None listed
Conditions
Brief summary
With the general ageing of the population attributed to Baby Boomers and the increase in life expectancy, attention of health consumers is turning from simply the treatment of chronic illness to increasing the span of good health (healthspan) as people age. The inflamma-ageing hypothesis proposes that much of the ageing process per se as well as chronic disease, even in healthy persons, is underpinned by chronic low-level inflammation. In pilot human studies undertaken by NatMed Research looking at their proprietary green-lipped mussel-based products as an anti-inflammatory treatment of osteoarthritis, the observation was made of changes in body composition in those persons receiving active medication. The current proposal is to undertake an open-label trial in middle-aged healthy women (without osteoarthritis) to determine if improvements in body composition and strength can be determined.
Interventions
Blend of two marine oils PCSO-524 (green-lipped mussel) and ESPO-572 (krill)
Two 200mg capsules will be taken orally twice daily for 26 weeks
Adherence will be done via capsule count and also by checking the level of red blood cell fatty acids
Approximately half of participants will have a dual X-ray absorptiometry scan - selection will be voluntary stratified into two groups, pre-menopausal and post-menopausal.
Sponsors
Pharmalink International Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Pre- and post menopausal women Not physically or mentally impacted by a severe acute or chronic medical condition Persons with Type 2 diabetes, well-controlled with or without medication, for greater than six months, will be eligible Persons on stable blood pressure or lipid medication for greater than three months will be eligible as long there is no diagnosis of a major cardiovascular disease. BMI greater than 18 and less than 35
Exclusion criteria
Women with osteoporosis Peri-menopausal women Having a pacemaker or other metallic implants Smokers, including vaping Allergy to shellfish, green-lipped mussels or Antarctic krill Pregnant or breast-feeding or planning to become pregnant in the next 6 months. Alcohol or drug addiction. Inability to cease taking current alternative medicines for the duration of the trial. Persons with kidney disease or impaired kidney function Persons with oedema Persons with severe vertigo
Outcome results
None listed