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New Zealand Green Lipped Mussel2021-10-12T16:43:05+05:30

New Zealand Green Lipped Mussel

What is Green Lipped Mussel Extract (GLME)?

The green lipped mussel is a shellfish that’s native to New Zealand (Perna canaliculus). Its name comes from the green lip around the edge of its shell. The green lipped mussel is one of the largest mussel species in existence, and can grow up to 240 mm in length.

The green lipped mussels are grown in dedicated farms in the pristine waters of New Zealand, usually in sheltered waters close to the shore. The mussel industry operates within some of the stringent quality standards in the world. Both the mussels and seawater around the farms are tested for Biotoxins, bacteria, and heavy metals. In addition, the water quality is constantly monitored with tests carried out to the standards set by the U.S Food and Drug Administration, European Union, and NZ Food Safety Authority.

New Zealand’s indigenous Maori people have claimed for centuries that consuming green lipped mussels has helped them maintain good health.

GLME or Green Lipped Mussel Extract performs two distinct anti-inflammatory activities.

The principal anti-inflammatory activity is due to a carbohydrate complex that has the ability to inhibit the emigration of neutrophils from the blood vessels. What this means, in everyday terms, is that soldier cells (neutrophils) are inhibited from attacking our own cells when an inflammatory stimulus is present. Preventing inflammation with its associated pain and reduced mobility symptoms is a primary requirement for an arthritis treatment.

Another valuable feature of the product is that it has been found to have natural gastro-protective properties. This means that, not only does it not damage the delicate stomach lining; it actually provides a protective function for it. Thus the product is able to relieve the inflammatory symptoms associated with arthritic diseases whilst protecting the stomach from the damaging effect of some pain-killers should a person need to be taking these at the same time.

What is the significance and effect of Green Lipped Mussel Extract (GLME) for bone and joint health?

GLME is a potent marine product that contains the components that the body requires to effectively relieve the symptoms of arthritis without inducing the classical adverse effects associated with many drug therapies. It is a reliable dietary supplement that works without causing any unpleasant effects. Even it has natural gastro-protective properties. It protects the delicate stomach lining. Thus the product is able to relieve the inflammatory symptoms associated with arthritic diseases whilst protecting the stomach from the damaging effect of some pain-killers should a person need to be taking these at the same time.

Following are the major benefits of GLME:

  • It improves the joint lubrication and therefore it increases the mobility of joints that are affected by the arthritis.
  • Cartilage is the slippery tissue which coats the ends of bones joint is formed. It prevents the cartilage decline and aids the repair of damaged cartilage. Therefore it is known to carry chondro protective actions.
  • It has gastro-protective actions. Therefore it protects stomach lining from the harsh medications that damage the delicate stomach lining of stomach used during the painful conditions of arthritis.
  • It has great anti-inflammatory actions. Therefore it decreases the pain, inflammation, and stiffness through different mechanisms.

How GLME is Better than Traditional Medicines?

The GLME is natural product with multi compounds. It has chondro-protective, gastro-protective and anti-inflammatory actions. It is effective in both osteoarthritis and rheumatoid arthritis. It has long-chain fatty acids and a wide range of therapeutic polysaccharides. Its higher doses will never show adverse effects. It produces the long lasting effects. A great care and wide safety measures are taken to acquire a higher quality of this product. Starting from the raw material till the extraction a great effort is done to avoid contamination with Biotoxins, microorganisms, pesticides and heavy metal contaminants. The GLM of licensed marine farms is used for extraction. Therefore the GLM extracts which are available to you are of highest international standards. While the traditional medicines or the herbal medicines available do not meet such standards of processing. Even the raw material in traditional medicines is not checked for the contamination. The medicinal parts of herbal medicines are generally not checked for the percentage of the active ingredients and components. Therefore there is great risk of side effects by using these medicines. Moreover it may take a long time to get relieved by using these medicines and there action may only be temporary.

The therapeutic effect results from the complementary effects of the unique combination of biologically active compounds found in the green-lipped mussel as follows:

Glycosaminoglycans (GAG) Synthesis

GLM Extract contains Glucosamine, Chondroitin sulphate, Hyaluronic acid and Dermantan Sulphate. GLM Extract is a natural source of glucosamine – not free glucosamine – a component of joint cartilage and of synovial fluid that has been shown to slow the structural damage within arthritic joints. Chondroitin sulphate makes up the basic ground substance of both, the bone and cartilage and may inhibit catabolic cytokine initiated degradation of the cartilage. Hyaluronic acid is a nonsulphated GAG found in the proteoglycans structure and it also contributes to the viscosity of the synovial fluid.

Inhibition of Cytokine Function

Cytokines are chemical messengers produced by cells in response to a variety of stimuli. Catabolic cytokines present in arthritic joints perform a number of detrimental functions, which result in an accelerated breakdown of cartilage and enhanced inflammation. The catabolic cytokines, Interleukin-1 (IL-1), Interleukin-2 (IL-2) and Tumor Necrosis Factor – alpha (TNF-) are the ones mainly associated with destructive function in the arthritic joint due to their influence on neutrophils infiltration, matrix metalloproteinase and proinflammatory prostaglandin production. Studies using arthritic rats have demonstrated the inhibitory effect of GLM Extract on neutrophils activity and pro-inflammatory prostaglandin synthesis along with the inhibition of catabolic cytokine activity at the cellular level.

Selective COX-2 Inhibition

GLM Extract is a selective inhibitor of cyclo-oxygenase type 2. Inhibiting the activity of cycloxygenase enzymes, which convert cell membrane phospholipids into pro-inflammatory prostaglandins, is an important anti-inflammatory mechanism. However, there are two isozyme of cycloxygenase, designated as COX-1 and COX-2. The COX-1 isozyme is a constitutional enzyme that has an important role in maintaining the health and integrity of the digestive system, kidney function and platelet aggregation whereas, COX-2 isozyme is induced in response to an inflammatory stimulus. The fact that GLM Extract is able to inhibit COX-2 selectivity without inhibiting COX-1 activity means that the product does not have any damaging effects on the stomach and does not adversely affect kidney function or platelet aggregation.

5-Lipoxygenase Inhibition

In addition to cyclo-oxygenase inhibitory activity, GLM Extract has been shown to inhibit 5-Lipoxygenase activity in stimulated human polymorphonuclear leukocytes in vitro. 5-Lipoxygenase activity is similar to cycloxygenase enzymic activity involving the conversion of endogenous arachidonic acid to proinflammatory and broncho-constrictive leukotrienes. These leukotrienes are adversely indicated in arthritic and asthmatic disorders and inhibition of their function is important for the control of these disorders.

Apoptosis Reduction

Apoptosis is a term used to describe programmed cell death. This is a normal physiological function but can become uncontrolled in some disease states. In arthritis, an elevated level of apoptosis can occur in the body′s white blood cells (T-lymphocytes). T-lymphocytes have been shown to be important mediators in the tissue destruction seen in rheumatoid arthritis. Animal studies have shown that GLM Extract inhibits the accumulation of T-lymphocytes at inflammatory sites. However, this is still to be proven in the case of human lymphocytes.

Inhibition of Histamine Production

Histamine production is normally associated with allergy reactions. However, it is also a component of the acute phase of inflammation and its control is therefore influential in the symptomatic relief of inflammatory disorders such as arthritis. Japanese researchers discovered that GLM Extract naturally contains an active anti-histamine component in the form of Phospholipid Lysolecithin. Although anti-histamine preparations are not a standard part of treatment of arthritic diseases, their complementary function in inhibiting the acute-mediator driven phase of inflammation is beneficial.

Micronutrients

GLM Extract is prepared from marine mussels, which have naturally assimilated micronutrients from their sea environment, in a manner, which retains all the components in a stable and functional state. Some minerals such as boron, manganese and copper have influence as anti-inflammatory agents either directly or synergistically with other mediators. Fat-soluble vitamins such as A, D, E and K are not in excess in GLM Extract and there is no danger of hypervitaminosis or biosynthesis of excess calcium.

Usages

  • Improves joint lubrication.
  • Prevents cartilage deterioration.
  • Promotes repair of damaged cartilage.
  • Improves mobility and range of motion of the affected joint.
  • Gastro-protective i.e. it protects stomach lining.
  • It appears to impact on the inflammatory process of arthritis via multiple mechanisms thereby reducing pain, stiffness and inflammation.

How GLME is better than NSAIDs?

NSAIDs (Non-steroidal anti-inflammatory drugs) are the drugs which are commonly used to get relief from pain, reduce fever or reduce inflammation in different conditions including arthritis. Also there are some strong NSAIDs which can improve your condition immediately but they causes severe side effects. It is true that NSAIDs provide rapid action but it is also true that they only provide temporary relief while the GLM provides you long lasting effects even if it′s action is slow. NSAIDs can damage your cartilage, can arouse stomach ulceration, and can cause renal dysfunction or hemorrhage. It may also dilute your blood by influencing the platelets, may increase your blood pressure, can increase the chances of heart attacks, and can stimulate the skin problems.

While the GLM extract aids you to regenerate and recover the cartilage. It is gastro-protective and do not effect adversely on platelets and renal function. It does not aggravate your blood pressure nor does it cause the risk of heart attacks. It may help you to treat the condition of psoriasis.

Therefore you can easily find that NSAIDS can show serious adverse effects while the GLM extract is completely safe.

How GLME is better than Glucosamine?

The GLME is natural product with multi compounds. It has chondro-protective, gastro-protective and anti-inflammatory actions. It is effective in both osteoarthritis and rheumatoid arthritis. It has long-chain fatty acids and a wide range of therapeutic polysaccharides. Its higher doses will never show adverse effects. On the other hand, glucosamine is a single compound product. It has only mild anti-inflammatory activity and provides joint and cartilage protection. It is beneficial in Osteoarthritis only. It contains no long-chain fatty acids and contains only one therapeutic polysaccharide. Its higher doses can cause serious unpleasant effects.

 

What are the Side Effects of GLME?

GLME does not show any side effects. However taking the GLME in following conditions will worsen your condition and will show unfavorable effects:

  • The use of GLME in the conditions of gouty arthritis worse the condition of a patient as it will elevate the levels of uric acid which is the major reason behind the gout.
  • The people who ever had suffered hypersensitivity to seafood should never use GLME as this will produce severe side effects.
  • The use of GLME along with the medications as blood thinners or monoamine oxidase in inhibitory drugs will show adverse effects.
  • GLME should never be used in the gestation or lactation period. It can be harmful for fetus and the nursing baby.
  • The use of GLME in children is not approved therefore keep it away from the reach of children.

What Are the Contraindications of Green Lipped Mussel Extract?

  • The people who are hypersensitive to the use of seafood should never use the Seatone.
  • The excess dosage of Seatone can cause nausea, fluid retention, rash or stomach disturbance.
  • People who are recommended by the doctor to use salt-free diet should abstain from the use of Seatone as it contains small amounts of natural sea salt and minerals.
  • Gout patients should not use the Seatone.
  • This product should not be used by the children and the women who are pregnant or lactating.
  • This product should not be administered by the people who are under the therapy of blood thinners or any other medications without the consultation of doctor.

What are the components of GLME?

Green lipped mussel (GLM) is an excellent source of essential nutrients. A great nutritional value of GLME is due to the presence of natural lipids, protein, and mineral content that are due to its marine origin. These nutrients make it highly beneficial for health. GLME also contains the natural omega-3 fatty acids and unique types of sterols. The wide range of minerals that are present in it makes it balanced marine nutritional product. It contains:

  • Protein: 40-50%
  • Carbohydrates: 5-20%
  • Lipids: 6-12%
  • Moisture: less than 5%

All these nutrients have unique properties that make it highly beneficial for health. It contains immune modulators, anti-inflammatory agents, and many essential building blocks that are required to rebuild collagen, synovial fluid and proteoglycans present in the joints, tendons and ligaments. The different components present in GLME have different roles as follows:

  • Glycosaminoglycans: The glycosaminoglycans present in it aids in the lubrication of joints, absorption of shocks and maintenance of articular cartilage.
  • Polysaccharide Glycogen: The Polysaccharide Glycogen present in the GLME inhibits the immune activation at the inflammation sites.
  • Poly unsaturated fatty acids: The Poly unsaturated fatty acids known as PUFA′s are the secondary anti-inflammatory agents.
  • Phospholipid Lysolecithin: The Phospholipid Lysolecithin has anti-histamine effects that decrease the acute phase inflammatory responses.
  • Lipid Fractions: The Lipid Fractions protects your stomach lining from the harsh medications and drugs.

How Glme is Obtained?

To obtain the best quality of GLME specific steps are required because only grounding up frozen and cooked mussel powder minimizes and destroys the effectiveness of the product. Therefore the best GLME is obtained after following steps:

Raw Material

Seatone is unique from other GLME as it is extracted only from the premium, fresh mussels when they are in peak condition only with the intention of producing a therapeutic product for joints.

Harvesting

The Company keeps full control of the practice, to make sure that harvesting is done at the best times of each year. Other companies do not take this much control so they use mussels of food-industry grade. Therefore they harvest the mussels year round rather than harvesting them at their peak condition.

Processing

In earlier research it was found that only simply drying and then encapsulating mussels will not produce a reliable product. Moreover the non-active components present in the mussels dilute the activity. Seatone is produced by using following two methods to prevent this issue:

  • Cold extraction method: Firstly cold extraction method is followed that removes the fresh mussel out of the shell and rapidly extracts and stabilizes the active component.
  • Freeze-drying method: Freeze-drying is done to preserve the product and stabilize it.

The Science Behind Biolane® GLME

Benefits of Biolane® GLME is supported by published double-blind, peer-reviewed clinical trials.

Biolane® GLME is also supported by cellular and animal research that helps explain the different mechanisms of action.

Biolane® GLM Extract covers over 20 Research studies conducted by reputable scientist and medical research institutes around the world.

Over 35 years of research has shown that Biolane® GLME is an effective anti-arthritic agent.

The Research was specifically conducted utilizing Biolane® active GLME. Due to the unique Biolane® manufacturing protocol, This research can only be applied to Biolane® GLM Extract and is not valid for other Green Lipped Mussel ingredients or products.

This section contains short summaries of the research studies that show Biolane® Extract’s effectiveness for joint health. Click here to read.

Clinical Studies & Trials

Cheras PA. Vascular Mechanisms in Osteo-arthritis: Rationale for Treatment with a Marine-Based Complementary Medicine, Osteo-arthritis and Cartilage 2005, Volume 13, page S95.

Cheras PA, Stevenson L, Myers SP. In-vitro Biological Activities of Biolane: A comparative study. ACCMER (Australia), Sep 2005

Study Aim

In vitro laboratory studies were undertaken by the Australian Centre for Complementary Medicine Education and Research (ACCMER), a joint venture of the University of Queensland and Southern Cross University. The aim of the studies was to compare selected biological activities of Healtheries′ Biolaneâ„¢ Green Lipped Mussel Extract versus the biological activities in a range of well known complementary anti-arthritic agents.

Sample Preparation

All samples were subjected to two enzyme digestions to simulate in vivo digestive processes. Various components of gastrointestinal secretions may have an impact on potential actives within a product. In this study we used a two stage in vitro model based on gastric and duodenal secretions. The digests prepared from the samples were a pepsin digest containing the prominent gastric enzyme pepsin and a complete digest where the sample was exposed to pepsin followed by pancreatic enzymes.

Assays

Assays assessed:
  • cholesterol synthesis inhibition
  • anti oxidant capacity
Inhibition of the following components of inflammatory pathways
  • tissue necrosis factor alpha (a)
  • Cox-2 expression
  • prostaglandin E2 (PGE2)
  • phospholipase A2 (PLA 2) – also associated with platelet aggregabillity
  • platelet aggregation inhibitory activity
  • fibrinolytic activity

Synopsis of Results

Comparison of aggregate in vitro data – Chondroitin Sulphate (CS) vs Glucosamine Sulphate (GS) vs Glucosamine sulphate:Chondroitin sulphate (GS/CS) vs LyprinolT vs Healtheries Biolaneâ„¢ Green Lipped Mussell Extract (GLME)

Test Anti-arthritic agent
CS GS GS/CS LYP GLME
Cholesterol biosynthesis inhibition
TNFa inhibition
Cox-2 inhibition ND
PGE2 inhibition
PLA2 inhibition *
Oxygen radical absorbance capacity – antioxidant (ORAC)
Fibrinolytic activity
Anti-platelet aggregation activity

Note denotes activity present denotes activity not found

* denotes activity not found at low concentration but present at higher concentration

ND = not done (test unable to be performed due to assay artefact)

The results show that Healtheries Biolaneâ„¢ Green Lipped Mussel Extract (GLME) demonstrates the most comprehensive range of activities across the suite of in vitro tests performed when compared with the other agents that were tested.

Relevance of the in vitro BiolaneT green lipped mussel extract (GLME) findings to putative Osteoarthritis pathomechanisms

The vascular theory of osteoarthritis causation is based on epidemiological, laboratory, experimental and clinical findings that support the concept that compromised microcirculation in affected joints initiated through a combination of inflammation and imbalance between coagulation and fibrinolysis can initiate and perpetuate the disease. One implication of this theory is that in order to treat more than just painful symptoms ie to slow or halt the disease process will require a range of biochemical activities to effectively break the web of pathology. It has been proposed that these should include a number of key activities such as anti-inflammatory, anticoagulant, fibrinolytic and lipolytic activities. If these are realised then chondroprotection is likely to ensue.

The use of highly potent anti-inflammatory agents, particularly the Cox-2 inhibitors would appear to be at odds with the known data showing that patients with osteoarthritis are at greater risk of thrombotic episodes than those without the disease. Cox-2 inhibitors pose a theoretical risk of increased thrombotic complications in many patients with osteoarthritis who already have cardiovascular risk factors. The recent removal of Vioxx from the market and restrictions governing the use of Celebrex – the Cox-2 market leaders, based on these concerns would appear to support this proposition.

A successful anti-arthritic agent should have multiple low level activities that address a range of disease drivers while avoiding the serious side effects that frequently accompany massive disruption of major biochemical pathways such as total Cox-2 inhibition.

The current in vitro study has shown that GLME has a range of activities that the vascular theory of osteoarthritis causation predicts as desirable for disease treatment. These include anti-inflammatory activity through its inhibition of TNFa, PGE2, Cox-2 and PLA2 in addition to its anti-oxidant activity. It is not critical for these activities to be at extremely high levels. In fact it is advantageous from the perspective of a low side effect profile that they should not be so. It is the multiplicity of activities that is of greater importance. In addition to anti-inflammatory activity, GLME also has in vitro activities that can reduce thrombotic risk (decreased PLA2 and cholesterol biosynthesis inhibition activity in addition to decreased platelet aggregability – that is also assisted through cholesterol biosynthesis inhibition) and enhance the removal of blood clots (mild fibrinolytic activity).

The results obtained in this study indicate that GLME has in vitro activities in key areas associated with arthritis pathophysiology. In addition, across the range of in vitro tests performed in this comparative study, Healtheries BiolaneT green lipped mussel extract demonstrated a more extensive range of potential anti-arthritic activities in comparison to the other agents tested.

It is important to note that these results apply specifically to BiolaneT Green Lipped Mussel Extract and can not be extrapolated to include other green lipped mussel extracts.

Advisory: This is not intended for the diagnosis or treatment of medical complaints. It is for information purposes only.

Kendall RV, Lawson JW, Hurley LA. New research and a clinical report on the use of Perna canaliculus (Biolane) in the management of arthritis. Townsend Letter for Doctors and Patients, July 2000; 99-111

Introduction

This paper includes the results of a laboratory research into the mechanisms of action of the mussel extract and also those from a 4-year clinical study involving 120 patients suffering osteo arthritis. The results, which originate from a university and also a clinical practice in the USA are once again excellent and fully support all the earlier positive data for the product.

Sixty-four males and fifty-six females made up this group with most patients in the age group of 60-70. Several of them had been referred total knee replacement. All patients in the study were provided information on the use of Green Lipped Mussel (GLM) for degenerative joint disease. They were advised that GLM Extract had been shown to have an anti-inflammatory effect equal to that of Indocin but more importantly it had a nutritive metabolic effect. The importance of mucopolysacharrides (glycosaminoglycans) in the formation of basic proteoglycans cartilage was stressed.

Patients with a known allergy to seafood, shellfish and alfalfa were excluded from the study but patients who were taking some form of NSAIDs or pain medication were allowed to continue but were requested to keep a record of all medications required.

Pain Assessment

The Huskinson visual analogue pain scale was used to assess pain where the pain intensity ranged from ” no pain” to “worst possible pain “. (Intensity Scale Fig. 1.)

Inflammatory Index

An estimate of overall inflammatory activity of the joints based upon clinical evidence of swelling, trauma, redness, heat and pain was made. A history of ” minutes of morning stiffness” as well as daily activity, participation in sports etc. was recorded by the patients.

The patient′s opinion of their condition in comparison to their initial state (same, a little better, a lot better, worse, much worse) was recorded. The physician′s evaluation was also made at the time of each visit (excellent, good, no change).

Notes were made as to tolerance of GLM Extract and compliance. Notes were also made in reference to the use of NSAID′s, pain medication, tropical cream and ointments.

The patients were prescribed 3 GLM Extract capsules (a total of 1500mg extract) per day taken with food and then 2 capsules daily as a permanent maintenance dose. The product used in the study contained 500mg GLM and 100mg alfalfa. The study was designed to last one year and out of 120 patients, only eleven were eventually elected for total knee replacement.

X-RAY evaluation

X-Rays of the patients were graded on the basis of a scale of I to IV using the Kellgren and Lawrence system – degree of osteoarthritis progressing by grade from grade I (minimal, least, severe) to grade IV (bone on bone).

The response to management in these groups of patients studied became evident at the time of the first follow-up visit. Many grade I & II patients who had presented with an initial analogue of 7 reported a 0 – 2. These patients continued to remain comfortable and active during the rest of the study.

Evidence of pain, heat and swelling was noted to be significantly diminished or absent during the remaining visits.

The two patients who were using canes no longer required them. A significant number of patients were able to reduce their NSAID intake by 50% or more. Most patients reported that their condition was much improved. No patient complained that his condition was worse.

Patient′s and Practitioner′s Assessments

95 patients reported of much improvement and 16 reported of some improvement. 9 patients reported of no change.

According to the practitioner, 19 patients (27%) had shown no improvement, 38 patients (31%) had shown good improvement and 63 patients (52%) had made excellent progress.

11 patients did eventually come for joint replacement therapy but felt that GLM protocol had bought them some more time.

Advisory: This is not intended for the diagnosis or treatment of medical complaints. It is for information purposes only.

Lambert M, Semark A, Grobler L. The ergogenic properties of Seatone (Biolane). Research Report by MRC/UCT Bioenergetics of Exercise Research Unit, UCT Medical School, Sport Science Institute of South Africa, 31st August 1998

In this study, conducted at the UCT Medical School in South Africa, the effects of Biolane GLME on recovery from muscle injury were compared with those of placebo in 20 highly trained athletes (cyclists). The cyclists took Biolane GLME for 3 weeks before muscle injury was induced. Peak power was greater and recovery of peak power faster in the group who were taking Biolane GLME than in those taking placebo. This is the first study to suggest that Biolane GLME can aid in the recovery of soft tissue injury in healthy individuals.

Advisory: This is not intended for the diagnosis or treatment of medical complaints. It is for information purposes only.

Audeval, B, Bouchacourt, P. Double blind, placebo-controlled study of the mussel Perna canaliculus (Biolane) in gonarthrosis (arthritis of the knee).
La Gazette Medicale 1986; 93 (38):111-115

Introduction

This double blind clinical study was conducted to the full European protocol as detailed in the European Directive on clinical trials of New Drugs Against Rheumatism. It was a very well conducted trial, involving 53 carefully matched patients over a period of six months. The trial was conducted at two Rheumatology centers in Paris and produced positive results indicating the effectiveness of the mussel extract for this condition.

The patient′s conditions were confirmed by a radiographic analysis and they had clinically experienced a steady pain for several weeks. The study lasted 6 months using 6 capsules (2100mg of GLM Extract per day) versus a matched placebo.

Ten efficacy measures were employed and patients were examined monthly. Results showed that the GLM Extract group was statistically superior to the placebo group in 4 of the 10 test areas:

  • Pain and discomfort
  • Functional index ARA
  • Patient′s opinion on results of treatment
  • Treatment effectiveness judged by the doctor

The placebo group showed a greater reduction in ′morning stiffness′ as compared to the GLM extract group.

Results

The results were also influenced by the severity of the illness. GLM Extract appeared to be more effective in less serious and moderate cases and not as effective in the more advanced stages.

The researchers concluded that GLM was effective by influencing the evolution of the arthritic illness – stopping the deterioration and enhancing the repair mechanism rather than by just working as an analgesic or purely as symptomatic anti-inflammatory agent.

Advisory: This is not intended for the diagnosis or treatment of medical complaints. It is for information purposes only.

Audeval, B, Bouchacourt, P. Double blind, placebo-controlled study of the mussel Perna canaliculus (Biolane) in gonarthrosis (arthritis of the knee).

La Gazette Medicale 1986; 93 (38):111-115

The study was conducted in two phases using four groups of five male and female Fischer rats.

Phase one involved monitoring the response of the rats to a single high dose (8g per kg bodyweight) of Seatone. No signs of toxicity were found and all amimals were alive and healthy 2 weeks after administration of the Seatone.

In phase two the rats were fed Seatone at a daily dose of 2g per kg bodyweight per day administered orally for 14 day. No signs of toxicity were found.

The animals were examined daily over a period of fourteen days. At the end of fourteen days the animals were euthanized and a post mortem conducted with heart, lungs, stomach and intestines being examined. Blood samples were also taken from the animals involved in the phase two experiment for determination of haematological parameters.

After two weeks all animals in both phases of the experiments were alive and healthy and it was found that Seatone did not exhibit acute toxicity. Due to the absence of toxic effects it was not possible to establish the LD50 for Seatone and the author concluded that the experiments demonstrated the Seatone does not exhibit acute toxicity when tested in rats.

In body weight terms of a 70 kg human, this would be equivalent to 120 gram per day. The recommended human dose in humans is 1 -1.2 gram per day.

FOOTNOTE: Long Term Toxicity.
The absence of toxic effects due to daily ingestion of Seatone over the long term has since been demonstrated by the fact that the product has been subjected to a number of clinical studies of duration up to six months in human subjects with no incidence of adverse events. In addition, widespread international use of the product by humans for more than 30 years has not resulted in any reports of toxic events.

Advisory: This is not intended for the diagnosis or treatment of medical complaints. It is for information purposes only.

Authors: TE Miller, HWu.

Dept of Medicine, University of Auckland, New Zealand. May 1981

The study monitored the teratogenic effects of Seatone using 20 breeding pairs of Dark Agouti rats for each of the test and control groups over a period of 6 months. The rats were fed either a standard diet or the diet containing Seatone for 90 days prior to mating.

The control animals were fed powdered pellets of a standard diet, and active group animals were fed Seatone blended in to a formulation that was estimated to equate to 50 time the recommended dosage for humans. Subsenquent analysis indicated that the formulation represented 54 times the recommended human dosage.

Autopsies were carried out on progeny from both groups at 21 days of age, test group, control group with rats from both groups also being processed for histological examination. Additionally, examination of near term (20 days) foetuses from the second litters of both groups, were examined for skeletal abnormalities and malformations.

No teratogenic effects were observed at the doses consumed (54 times normal)

The litter sizes in the Seatone fed group were significantly smaller although the average weight of the Seatone progeny was greater at both 4 and 21 days.

The study concluded that Seatone delayed conception. There were no skeletal abnormalities or malformations in either group but delayed skeletal development was observed in a greater number of animals in the Seatone group to those in the control group.

Advisory: This is not intended for the diagnosis or treatment of medical complaints. It is for information purposes only.

Gibson RG, Gibson SL, Conway V, Chappell D. Perna Canaliculus (Biolane) in the treatment of arthritis.
The Practitioner September 1980, 955-960

Introduction

This was the first long term double blind clinical study to be conducted on the mussel extract and it produced very exciting results. The results indicated that the product was not only successful in treating the rheumatoid forms of arthritis but also osteo arthritis.

In a preliminary test carried out with 86 patients, 55 had rheumatoid arthritis and 31 had osteo arthritis. The trial results indicated that 67.9% of the rheumatoid patients and 39.5% of the osteo patients benefited from GLM supplementation . An interesting point relating to these figures is that they agreed with those compiled from unsolicited anecdotal reports originating from people in countries all around the world.

This was followed by a double blind, placebo controlled study involving an additional 66 patients. Of these, 28 had rheumatoid and 38 had clinical and radiological evidence of osteo arthritis. All patients were taking some form of NSAIDs.

Clinical assessments like the ones mentioned below were monitored before and after a 3-month trial period where the test group received 1050mg of GLM extract per day and the control group received the placebo:

  • Joint mobility
  • Pain index
  • Swelling
  • Function tests
  • Laboratory indices

Results

Results of the study, after removing eight patients who dropped out due to unrelated reasons, were as follows: 76% of the rheumatoid and 45% of the osteo arthritis group reported improvement in the form of reduced pain/ stiffness. A total of 23 out of 58 (40%) in the study showed no improvement. Grip strength did not significantly improve in the in the treatment group. Side- effects were minimal, apart from initial exacerbation of symptoms experienced by six of the 66 patients in the trial from two to four weeks after starting the study. This increased sensitivity lasted from one to two weeks after which the individuals generally reported improvement in their symptoms. Dosage of GLM Extract dropped to 750mg per day once a positive response was seen.

Advisory: This is not intended for the diagnosis or treatment of medical complaints. It is for information purposes only.

Pollard B, Guilford WG, Ankenbauer-Perkins KL, Hedderley D. Clinical efficiency and tolerance of Biolane GLME in dogs presumptively diagnosed with degenerative joints disease. New Zealand Veterinary Journal 54 (3) 114-118, 2006

81 dogs diagnosed with DJD were treated orally daily with either GLME or placebo for 56 days in a double blind, placebo-controlled study.

In conclusion, the results of this study suggest that Biolane containing treatment used was well tolerated and had a significant beneficial effect on the clinical signs of dogs diagnosed with DJD.

Advisory: This is not intended for the diagnosis or treatment of medical complaints. It is for information purposes only.

GLME FAQs

Find out from the company you are purchasing product from where their product is made. Do they manufacture themselves or is the product contract manufactured and packed off by themselves. Speak to the person in charge of quality control procedures. Find out their qualifications and find out to what lengths the company goes to ensure the quality of their products. How much is spent and how many people are employed to carry out quality control procedures. Find out what back up services this company provides. Are there experts available to advise you if you have problems? Are your questions dealt with promptly and thoroughly?

Most supplements are best taken straight after a meal. Because they are concentrated they should be mixed with food in your stomach. Herbs are best taken 20 minutes before a meal if taken to improve digestion or otherwise 20 minutes after meals. Amino acids should be taken between meals for increased absorption. Minerals such as Calcium and Magnesium, which have natural relaxing properties, are best taken with water or fruit juice on an empty stomach before bed. If you require Calcium, Iron and Zinc, take all 3 at separate meals to avoid competition for absorption.

Store them in a cool dry place below 30°C. Do not refrigerate as moisture can adversely affect stability of tablets and capsules. Do not throw away the moisture absorbing sachet present in the bottle until the product is finished.

Do not take them all at once. Take them in divided doses up to 3 times daily to ensure a regular level is present in the blood.

RDA refers to ′Recommended Daily Allowance′ and RDI ′Recommended Daily Intake′. The first RDA′s were developed in the USA in 1941 by the Food and Nutrition Board of the National Academy of Sciences. The USA Government faced with entering World War II and anticipating food rationing and problems with food supplies to the armed forces, wanted to ensure proper nutrition within a limited availability of food, avoiding deficiency diseases such as scurvy, pellagra or beriberi.

RDA′s are a broad guideline for measuring adequate national dietary intakes and the overall nutritional status of the whole population and vary from country to country. They should not be confused with individual requirements which have many variables such as those brought about by illness, e.g. arthritis, asthma, eczema, diabetes, heart disease, etc; vegetarians, vegans, medication users, heavy alcohol users, smokers, pregnant or breastfeeding, teenagers who have not completed their own growth process and those who have injuries or are overcoming surgery. Although the use of RDA′s have almost eliminated deficiency diseases such as scurvy, beriberi and pellagra, it is not a good measure of the health of the population as it does not take into account an individual′s needs.

Vitamin and mineral deficiencies adversely affect our health. Initially, the deficiency reduces our tissue stores leading to reduced enzyme activity and causing abnormal metabolism as vitamins and minerals are essential for enzyme activation. As the deficiency progresses there can be unspecific changes occurring such as reduced immunity, fatigue, or changes in behavior such as irritability or depressed feelings. Ultimately classical deficiency signs and symptoms occur such as broken blood capillaries, easy bruising, bleeding gums (Vitamin C) and if deficiency continues physiological changes resulting in death can occur, as occurred in scurvy.

Today it is rare to see cases of scurvy because most people get some Vitamin C in their diet. However, it is not uncommon to see clinical signs occurring as a result of insufficient Vitamin C as caused by reduced dietary intake of fresh fruit and vegetables or as a result of increased need for Vitamin C caused by smoking or medications such as Prednisone. Not only do our food choices affect our nutrient intake, but also agricultural methods, food storage, processing, and meal preparation.

Our lifestyle choices e.g. smoking, alcohol or endurance sports as well as the presence of any health condition or regular use of medication, e.g. contraceptive pill, affect our particular need for specific vitamins and minerals.

Supplements provide vitamins and minerals normally found in food. Some medications increase the need for specific nutrients, particularly Vitamin C, folic acid or B complex and liver supporting herbs such as Milk Thistle. There are occasions, however, when supplements interfere with some medications e.g. taking calcium, magnesium, iron or other minerals with the antibiotic tetracycline. You should also avoid nutrients or herbs that have blood thinning effects such as Vitamin E, Omega 3, Co Enzyme Q10, Horse chestnut, Sweet clover (mellilotus), Ginkgo biloba and high dose Garlic or Ginger, if taking anticoagulants such as warfarin.

Adverse drug-nutrient interactions are actually quite rare and the over-whelming majority of interactions are positive. Drugs like Sulfasalazine used to treat colitis or rheumatoid arthritis deplete folic acid. Aspirin depletes Vitamin C and folic acid, diuretics deplete minerals and the contraceptive pill depletes the B complex vitamins and a range of minerals. The list is extensive so finding a doctor who can give you advice on both conventional and nutritional medicine, or seeing a naturopath or checking with your pharmacist that what you are taking won’t interfere with your medication is advisable. If none of these options are helpful contact the company whose products you are taking and request the appropriate information.

Vitamin A, D and Selenium when taken in excess can cause toxicity. When combining products ensure you (adults) do not take more than the following on a daily basis:

Vitamin A (retinol) 3000mcg (10,000 IU) Vitamin D 25mcg (1,000 IU) Selenium 200mcg (the limit per tablet in NZ is 150mcg, however there is no evidence of toxicity at 200mcg daily or less per adult dose)

We also recommend you do not exceed the following on a daily basis: Copper 5mg Iron 24mg (unless anemic or low iron stores) Zinc 15mg

It is advised that men should not take iron tablets unless diagnosed by a blood test to be low in iron. Vitamin A supplementation during pregnancy should not exceed 2500 IU, as high dose Vitamin A has been shown to cause fetal abnormality.

Tablets can be crushed and capsules can be cut, the contents squeezed out and blended with fruit juice and fruit if you have difficulty swallowing supplements.

Dietary supplements are best taken just after a meal with either water or fruit juice.

It has long been thought that dietary supplements are not needed by people who eat varied diets. However, in the past 10 years there is increasing nutritional research showing the potential benefits of nutrients above the RDA′s in reducing the risk of diseases not recognized as classic deficiency diseases, e.g.

  • Calcium 1000mg-2000mg: Slows the decline of bone density reducing the risk of osteoporosis. [Calcium RDA is 800mg]
  • Folic Acid 400mcg+: Before conception and in early pregnancy decreases the risk of baby developing neural tube defects, e.g. spina bifida.
  • Vitamin E 400 IU daily or greater, significantly decreased low density lipoprotein (LDL) cholesterol oxidation in blood compared with 200 IU or less of Vitamin E which showed no such effects.
  • Vitamin E 400 IU-800 IU daily showed a significant decrease of non fatal heart attacks in people who were at high risk. [Vitamin E RDA is 10 IU]
  • Selenium 200mcg daily significantly decreased total incidence and lung cancer deaths and total colorectal and prostate cancer incidence.

The length of time you will require dietary supplementation depends on the reason you are taking them, e.g. if your diet is deficient in iron, you will require iron supplementation until your blood tests are normal. After which time if you have increased your intake of iron containing foods, ongoing supplementation won′t be necessary.

However, if you are on medication that affects nutrient levels or you have a specific health problem, ongoing supplementation maybe beneficial. If you have any doubts about what you are taking, we suggest you consult a naturopath or contact the company whose products you are taking.

This is due to the presence of the B-Complex Vitamin riboflavin. It is a sign that your body is absorbing the B vitamins well and that any excess to your needs is passing out in your urine.

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