LYPRINOL RESEARCH

July, 2002

  The human trials are as follows:

Published:

1.     Gibson Study in Glasgow - Treatment of Arthritis with Lyprinol (Complementary Therapies in Medicine (1998)).

 

2.     Steve Hooper - The Effect of Marine Oils on Markets of Thrombosis in the blood of healthy Females (October 1998).

 

3.   Sheila L M Gibson - The Effect of a Lipid Extract of the New Zealand Green - Lipped Mussel in Cases of Arthritis (The Journal of Alternative and Complementary Medicine, volume 6, Number 4, 2000).

 

4.   Clinical Efficacy and Safety of LYPRINOL, a patented Extract from New Zealand Green Lipped Mussel (Perna canaliculus) in Patients with osteoarthritis of the Hip and Knee: Multicentre Clinical Trial with a 2-Month Treatment Period published in the “Newest Medical Journal” (Korea) 2002 5.6 ISSN 0529-3804 (pages 27-33) and the European Annals of Allergology & Clinical Immunology of June 2003.

5.   A Emelyanov, P J Barnes - Treatment of asthma with lipid extract of New Zealand green-lipped mussel (The European Respiratory Journal, Vol. 20, Issue 3 - September 2002).

 
  1. Gibson R.G., Gibson S.L.M.  Green-lipped mussel extract in arthritis.  Lancet 1981;1:149.
 
  1. A N Naykhin, R Borland, L G Rudenko - LYPRINOL - A New Modulator of Human Immune Response to viral Antigen (submitted to the "Medical Research Journal of the Russian Academy of Medical Sciences" (Issue No. 4 October, 2003)).
 
  1. Treatment of knee osteoarthritis with Lyprinol, lipid extract of the green lipped mussel – double blind placebo – controlled study published in “Progress in Nutrition” Volume 6; Numero 1/2004; Issn 1129-8723 pages 17-31.


 

 Scientific and Medical Developments in Progress 
  1. Pavlov Medical University Study of Lyprinol™ and Moderate Asthma. This is an ongoing study being conducted by Professor A. Emelyanov of the Department of Allergy and Lung Diseases, Pavlov Medical University, St. Petersburg Russia.  The primary objective is to compare the efficacy in patients with moderate to severe asthma treated with Pulmicort Turbuhaler with and without the lipid extract of the New Zealand green lipped mussel (Lyprinol™).  This study is expected to be completed by the end of 2005. 
 
  1. Juvenile Asthma Study.  This is a clinical study to be conducted in cooperation with the New Zealand Asthma Foundation to investigate if Lyprinol can alter the pathogenesis in moderate to severe asthma as demonstrated by the reduction in the use of reliever medication, and minimization of the use of inhaled corticosteroids in children.  This study is a single centre, randomized, double blind, placebo controlled comparative study on 120 children between 6 and 13 years old, with persistent asthma to obtain the effect of Lyprinol in minimizing the requirement for inhaled corticosteroids (IHC) and the use of short acting beta2 agonists (SABAs) as reliever medication.  Estimation completed date June 2006. 
 
  1. The Efficacy of Lyprinol™ in the Prevention and Treatment of Delayed Onset Muscle Soreness (DOMS) and Muscle Damage in Sub-elite Athletes.  A randomised, double blind, placebo controlled trial that looks at Lyprinol™ and its effect on DOMS and muscle damage in sub-elite athletes.  Each athlete will be subjected to a downhill running protocol that inflicts DOMS through eccentric exercise.  Trial participants are randomly assigned the medicine Lyprinol or placebo after being matched based on an initial modified downhill running protocol, performance measurements and pain scales to prevent inter-individual variability.  All trials will be conducted at The Australian Institute of Sport under the direction of Kate Pumpa (PhD Scholar) and Associate Professor Kieran Fallon in Australia.  Completed but results being compiled.
 
  1. Modification of Inflammatory Activity in Rheumatoid Arthritis Patients Treated with Lyprinol™.  A double blind clinical study to be conducted by Dr. Daniel Lewis, Andrew Sinclair and G. Tooley. The Objective of this study is to examine the clinical and laboratory responses to the use of oral Lyprinol™ in addition to standard therapy in individuals with active rheumatoid arthritis.  The study will be a placebo controlled 12 week study program in 40 patients with active rheumatoid arthritis.  The study had been approved by the Ethics Committee at Deakin University in Australia.  To be completed September 2005.
 

Studies Completed and not yet submitted:

1.  Niels Hertz Study - Pilot Study 22 Patients with OA in the hip and knee.  Conducted in Denmark.


 

 LYPRINOL ABSTRACTS 1.  In Brief...Musseling in   

Annotated Title- Lyprinol , a New Zealand joint pain supplement, is being distributed in UK pharmacies; the product, derived from green lipped mussels, works by blocking metabolic pathways involved in inflammation

BNI   00-09   02317834  NDN- 173-0277-0152-7

 

JOURNAL NAME- Community Pharmacy   

1999-12-00   

PAGE- 36   

DOCUMENT TYPE- Journal; News Brief   

SOURCE DESCRIPTION- News Brief   

JOURNAL CODE- COMMPHMF   

ISSN- 0960-376X   

AVAILABILITY NOTE- THIS IS THE COMPLETE ARTICLE   

PUBLICATION COUNTRY- United Kingdom   

SOURCE OF ARTICLE(S)- Journal   

INDUSTRY- Pharmaceutical   

WORD COUNT- 66   

LANGUAGE- English   

 

NO-ABSTRACT

 

New Zealand joint pain supplement Lyprinol is being distributed into UK pharmacy.

 

Derived from the New Zealand green lipped mussel, this product is claimed to be 250 times more potent than unstabilised Green Lipped Mussel extracts.

 

Lyprinol is said to work by blocking metabolic pathways involved in the inflammation process and may be helpful in osteoarthritis and rheumatoid arthritis. It retails at UKPd24.95 for 50 capsules.

Copyright 1999 Miller-Freeman plc


 

 2.  Anti-inflammatory activity of a lipid fraction ( Lyprinol ) from the NZ green-lipped mussel.   

BIO   01-02   01-009763  NDN- 007-0639-3430-2

 

Whitehouse, M. W.; Macrides, T. A.; Kalafatis, N.; Betts, W. H.; Haynes, D. R.; Broadbent, J.   

 

JOURNAL NAME- Inflammopharmacology   

VOL. 5   

NO. 3   

1997   

PP. 237-246   

ISSN- 0925-4692   

AUTHOR AFFILIATION- Dep. Med., Univ. Queensland, Princess Alexandra Hosp., Brisbane, QLD 4102, Australia   

LITERARY INDICATOR(S)- RESEARCH ARTICLE   

PRINT PRODUCT NUMBER- Biological Abstracts Vol. 105 Iss. 001 Ref. 009763   

LANGUAGE- English   

 

A lipid-rich extract, prepared by supercritical fluid extraction of fresh stabilized mussel powder ( Lyprinol ), showed significant anti-inflammatory (AI) activity given therapeutically and prophylactically po to Wister and Dark Agouti rats developing either (a) adjuvant-induced polyarthritis or (b) collagen(II)-induced autoallergic arthritis, with ED-50 ltoreq 15 mg/kg; or various therapeutic oils (flaxseed, evening primrose, fish) gtoreq 1800 mg/kg given orally. Lyprinol showed little or no activity in acute irritation assays (carrageenan, kaolin, histamine) indicating it is not mimicking rapid-acting NSAIDs. Incorporating Lyprinol into arthritigenic adjuvants composed of heat-killed Mycobacterium. tuberculosis suspended in olive oil or squalane, effectively prevented arthritis development at a dose of 5 mg/rat. By contrast, 'dummy adjuvants' prepared with Mycobacterium tuberculosis and flaxseed, evening primrose or fish oils were still arthritigenic in Dark Agouti rats (doses of oil = 90 mg/rat). Lyprinol subfractions inhibited leukotriene-B-4 biosynthesis by stimulated human polymorphonuclear leukocytes in vitro, and prostaglandin-E-2 production by activated human macrophages in vitro. Much of this Al activity was associated with polyunsaturated fatty acids and natural antioxidants (carotenoids, etc). In contrast to NSAIDs, Lyprinol is non-gastrotoxic in disease-stressed rats at 300 mg/kg po and does not seem to affect platelet aggregation (human, rat). These data show Lyprinol to be a reproducible, relatively stable, source of bioactive lipids with much greater potency than plant/marine oils currently used as nutritional supplements to ameliorate signs of inflammation.   


 

 3.  Natural relief for inflammation of sprains, strains, and arthritis   

IPA   01-09   1226380  NDN- 118-0133-1293-9

 

Meletis, C. D.   

 

JOURNAL NAME- Alternative & Complementary Therapies (England)   

VOL. 6   

NO. Jun   

2000   

PP. 141-144   

   

An overview of natural remedies for the relief of inflammation of sprains, strains, and arthritis is presented, including the natural anti inflammatories lyprinol , bromelains (bromelain), curcumin, and flavonoids, and other clinical tips for the management of inflammation of sprains, strains, and arthritis.   

ABSTRACTOR'S NAME- M. Therese Gyi   

Bromelains   

 


 

 4.  Possible steroid-sparing effect in asthma of lyprinol , a shellfish lipid extract.   

MED   01-03   21032754  NDN- 222-0203-7035-0

 

Harbison, S. J.; Whitehouse, M. W.   

 

JOURNAL NAME- Med J Aust   

VOL. 173   

NO. 10   

2000 Nov 20   

PP. 560   

DOCUMENT TYPE- Letter   

JOURNAL CODE- M26; 0400714   

JOURNAL SUBSET- MEDJSIM   

ISSN- 0025-729X   

PUBLICATION COUNTRY- Australia   

LANGUAGE- English   

 

NO-ABSTRACT


 

 5.  Lyprinol inhibits LTB4 production by human monocytes.   

MED   01-03   20546382  NDN- 222-0203-2609-9

 

Dugas, B.   

 

JOURNAL NAME- Allerg Immunol (Paris)   

VOL. 32   

2000 Sep   

PP. 284-9   

DOCUMENT TYPE- Journal Article   

JOURNAL CODE- AEI; 0245775   

JOURNAL SUBSET- MEDJSIM   

ISSN- 0397-9148   

CORPORATE AUTHOR- Oxykine Therapeutics S.A., Paris, France.   

PUBLICATION COUNTRY- FRANCE   

LANGUAGE- English   

 

The effect of Lyprinol was evaluated on LTB4-induced human monocytes (normal and allergic donors) activation. Peripheral blood normal monocyte-derived monocytes when stimulated by Interleukin-4 (IL-4) produced high amounts of leukotriene B4 (LTB4) through the activation of the 5-lipoxygenase pathway. Maximal effect was observed in the presence of 10 ng/ml IL-4, and maximal LTB4 production was reached 40 min after the onset of stimulation. When stimulated for 48 h with IL-4, resting human monocytes expressed and released the low affinity receptor for IgE (CD23), and were inhibited in the presence of Lyprinol , or of the non redox 5-lipoxygenase inhibitor (BW B70C), suggesting that the production of LTB4 partially contributed to the IL-4-induced CD23 expression and release. In addition to these phenotypical changes, IL-4 primed the phorbol-12-myristate-13-acetate (PMA)-induced luminol-dependent chemiluminescence response (LDCL) by normal human monocytes; this priming effect was abrogated in the presence of Lyprinol , or of BW B70C. Monocyte-derived monocytes from allergic patients spontaneously produced high amounts of LTB4, expressed CD23 expression, and had an increased oxidative metabolism. In the presence of Lyprinol , or of BW B70C, the hyper-activation of monocytes from allergic patients was significantly suppressed. Taken together, these data indicated that the pharmacological control of the 5-lipoxygenase pathway in human monocytes can be achieved with Lyprinol , and that the activation of this pathway could upregulate the expression and release of CD23 and the respiratory burst of human monocytes.   


 

 6.  Lyprinol : anti-inflammatory and uterine-relaxant activities in rats, with special reference to a model for dysmenorrhea.   

MED   01-03   20546381  NDN- 222-0203-2608-7

 

Shiels, I. A.; Whitehouse, M. W.   

 

JOURNAL NAME- Allerg Immunol (Paris)   

VOL. 32   

2000 Sep   

PP. 279-83   

DOCUMENT TYPE- Journal Article   

JOURNAL CODE- AEI; 0245775   

JOURNAL SUBSET- MEDJSIM   

ISSN- 0397-9148   

CORPORATE AUTHOR- Department of Pharmacology, University of Queensland Brisbane, Australia.   

PUBLICATION COUNTRY- FRANCE    

LANGUAGE- English   

 

Lyprinol exhibits anti-inflammatory activity distinct from that of most NSAIDs, controlling chronic but not acute inflammation. Unlike Cox-1 inhibitors (aspirin, meclofenamic acid) it is not gastro-toxic. Predosing rats with Lyprinol can modify both (i) the spontaneous and (ii) the oxytocin-induced contractions of the uterus. In humans there is anecdotal evidence that Lyprinol can relieve dysmenorrhea. This report explores the concept that the uterotrophic actions of Lyprinol are conditioned by: the intrinsic profile of estrogenic hormones and progestagens and, certain extrinsic stimuli. Evidence from in vitro studies indicates that Lyprinol is not a smooth muscle relaxant and that its uterotrophic mechanism is not that of a cyclo-oxygenase inhibitor, but may mimic that of a leukotriene receptor antagonist.   


 

 7.  Anti-inflammatory effects of a stabilized lipid extract of Perna canaliculus ( Lyprinol ).   

MED   01-03   20546380  NDN- 222-0203-2607-5

 

Halpern, G. M.   

 

JOURNAL NAME- Allerg Immunol (Paris)   

VOL. 32   

2000 Sep   

PP. 272-8   

DOCUMENT TYPE- Journal Article; Review; Review, Tutorial   

JOURNAL CODE- AEI; 0245775   

JOURNAL SUBSET- MEDJSIM   

ISSN- 0397-9148   

CORPORATE AUTHOR- University of California, USA.   

PUBLICATION COUNTRY- FRANCE   

LANGUAGE- English   

 

A lipid-rich extract, prepared by supercritical fluid (CO2) extraction of freeze-dried stabilized NZ green-lipped mussel powder ( Lyprinol ) has shown significant anti-inflammatory (AI) activity when given to animals and humans. When treated p.o. with Lyprinol , Wister and Dark Agouti rats developed neither adjuvant-induced polyarthritis or collagen(II)-induced auto-allergic arthritis. This was achieved with doses 60 NSAIDs, and 200 times 60 of other seed or fish oils. Lyprinol subfractions inhibited LTB4 biosynthesis by PMN in vitro, and PGE2 production by activated macrophages. Much of this AI activity was associated with omega-3 PUFAs and natural antioxidants e.g. carotenoids . In contrast to NSAIDs, Lyprinol is non-gastro toxic in disease-stressed rats at 300 mg/kg p.o., and does not affect platelet aggregation human, rat . Clinical studies, either controlled or randomized, have demonstrated very significant AI activity in patients with osteoarthritis (OA), rheumatoid arthritis (RA), asthma, and other inflammatory conditions. Lyprinol is a reproducible, stable source of bioactive lipids with much greater potency than plant/marine oils currently used as nutritional supplements to ameliorate signs of inflammation.   


 

 8.  Marine lipids: overview "news insights and lipid composition of Lyprinol ".    MED   01-03   20546379  NDN- 222-0203-2606-3  

Sinclair, A. J.; Murphy, K. J.; Li, D.   

 

JOURNAL NAME- Allerg Immunol (Paris)   

VOL. 32   

2000 Sep   

PP. 261-71   

79 reference(s)   

DOCUMENT TYPE- Journal Article; Review; Review, Tutorial   

JOURNAL CODE- AEI; 0245775   

JOURNAL SUBSET- MEDJSIM   

ISSN- 0397-9148   

CORPORATE AUTHOR- Department of Food Science, RMIT University, Melbourne, Victoria, Australia.   

PUBLICATION COUNTRY- FRANCE   

LANGUAGE- English   

 

The omega 3 polyunsaturated fatty acids have had a major impact on thinking in medicine in the last twenty years. The parent fatty acid in the omega 3 fatty acid family is alpha-linolenic acid (ALA) which is an essential fatty acid found in high concentrations in certain plant oils, such as flaxseed oil, walnut oil and canola oil. Several longer chain or derived omega 3 fatty acids are formed from alpha-linolenic acid and these are mainly found in fish, fish oils and from other marine organisms. The main marine omega 3 fatty acids are eicosapentaenoic acid (EPA), docosapentaenoic acid and docosahexaenoic acid (DHA). It is of interest that DHA is specifically localised in the retina and the brain in humans and other mammals. The longer chain omega 3 fatty acids are rapidly incorporated into cell membrane phospholipids where it is regarded they influence the metabolism/metabolic events within the cells. The mechanisms by which these changes occur include alteration in the fluidity of membranes such that there are subtle changes in receptor function, alteration in cell signalling mechanisms, membrane-bound enzymes, regulation of the synthesis of eicosanoids, and regulation of gene expression. In this chapter, we report a comparison between the composition of the oil derived from the New Zealand Green Lipped Mussel ( Lyprinol ') and two other oils rich in omega 3 fatty acids, namely flaxseed oil and tuna oil. The main lipid classes in Lyprinol ' were sterol esters, triglycerides, free fatty acids, sterols and phospholipids while triglycerides were the main lipids in the other two oils. The main omega 3 fatty acids in Lyprinol ' were EPA and DHA, while in flaxseed oil and tuna oil the main omega 3 fatty acids were ALA and DHA, respectively. The main sterols in Lyprinol ' were cholesterol and desmosterol/brassicasterol, while in flaxseed oil and tuna oil the main sterols were beta-sitosterol and cholesterol, respectively. Epidemiological observations, populations' studies and basic research indicate the possibility of influencing the outcome of cardiovascular disease, inflammatory disorders and neural function by ingestion of the omega 3 polyunsaturated fatty acids.   


 

 9.  An anti-inflammatory from the South Seas: Lyprinol    

MED   01-03   20546378  NDN- 222-0203-2605-1

 

Halpern, G. M.   

 

JOURNAL NAME- Allerg Immunol (Paris)   

VOL. 32   

2000 Sep   

PP. 259-60   

DOCUMENT TYPE- Journal Article   

JOURNAL CODE- AEI; 0245775    

JOURNAL SUBSET- MEDJSIM   

ISSN- 0397-9148   

PUBLICATION COUNTRY- FRANCE   

LANGUAGE- French   

NO-ABSTRACT

   SCIENTIFIC AND MEDICAL DEVELOPMENTS  (a)  Pavlov Medical University Study of Lyprinol™ and Moderate Asthma. This is an ongoing study being conducted by Professor A. Emelyanov of the Department of Allergy and Lung Diseases, Pavlov Medical University, St. Petersburg Russia.  The primary objective is to compare the efficacy in patients with moderate to severe asthma treated with Pulmicort Turbuhaler with and without the lipid extract of the New Zealand green lipped mussel (Lyprinol™).  This study is expected to be completed by the end of  2004. (b)  Juvenile Asthma Study.  This is a clinical study to be conducted in cooperation with the New Zealand Asthma Foundation to investigate if Lyprinol can alter the pathogenesis in moderate to severe asthma as demonstrated by the reduction in the use of reliever medication, and minimization of the use of inhaled corticosteroids in children.  This study is a single centre, randomized, double blind, placebo controlled comparative study on 120 children between 6 and 13 years old, with persistent asthma to obtain the effect of Lyprinol in minimizing the requirement for inhaled corticosteroids (IHC) and the use of short acting beta2 agonists (SABAs) as reliever medication.  The study design has now been completed and will be submitted for Ethics Approval. Modification of Inflammatory Activity in Rheumatoid Arthritis Patients Treated with Lyprinol™.  A double blind clinical study to be conducted by Dr. Daniel Lewis,  Andrew Sinclair and G. Tooley. The Objective of this study is to examine the clinical and laboratory responses to the use of oral Lyprinol™ in addition to standard therapy in individuals with active rheumatoid arthritis.  The study will be a placebo controlled 12 week study program in 40 patients with active rheumatoid arthritis.  The study had been submitted for ethics approval at Deakin University in Australia. (c)  The Efficacy of Lyprinol™ in the Prevention and Treatment of Delayed Onset Muscle Soreness (DOMS) and Muscle Damage in Sub-elite Athletes.  A randomised, double blind, placebo controlled trial that looks at Lyprinol™ and its effect on DOMS and muscle damage in sub-elite athletes.  Each athlete will be subjected to a downhill running protocol that inflicts DOMS through eccentric exercise.  Trial participants are randomly assigned the medicine Lyprinol or placebo after being matched based on an initial modified downhill running protocol, performance measurements and pain scales to prevent inter-individual variability.  All trials will be conducted at The Australian Institute of Sport under the direction of Kate Pumpa (PhD Scholar) and Associate Professor Kieran Fallon in Australia. (d)  Modification of Inflammatory Activity in Rheumatoid Arthritis Patients Treated with Lyprinol™.  A double blind clinical study to be conducted by Dr. Daniel Lewis, Andrew Sinclair and G. Tooley. The Objective of this study is to examine the clinical and laboratory responses to the use of oral Lyprinol™ in addition to standard therapy in individuals with active rheumatoid arthritis.  The study will be a placebo controlled 12 week study program in 40 patients with active rheumatoid arthritis.  The study had been approved by the Ethics Committee at Deakin University in Australia.