None listed
Conditions
Brief summary
This study is being conducted to assess the safety of a novel health supplement (PMB676) in healthy volunteers. The supplement is an extract of green-lipped mussels containing an ingredient called plasmalogens, which are a type of lipid naturally present in the cells of our bodies. Preliminary research has shown potential for a plasmalogen supplement to support cognitive decline in aging. The present study will not be investigating the effectiveness of the supplement but aims to investigate if it is safe to take and if changes in the lipid levels within the blood and blood cells can be seen after taking the supplement for 12 weeks.
Interventions
Trial Product: PMB676 (Purified green lipped mussel extract containing 5mg plasmalogens per capsule)
Dose Weeks 1-6: one capsule per day (5 mg)
Dose Weeks 7-12: two capsules per day (10 mg)
Route: oral
Duration: 12 weeks
Compliance monitored by return tablet count.
Sponsors
Southern Cross University
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
35 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adults 35 to 65 years 2. BMI between 18.5 to 35 kg/m2
Exclusion criteria
General -Current, clinically significant acute disease -Indicators of a current, unmanaged and clinically significant chronic disease (per PI review of participant self-reported medical history) -Current, clinically significant digestive absorption deficiency, i.e. Crohn’s Disease, ulcerative colitis, severe irritable bowel syndrome, any condition characterised by severe diarrhoea or severe constipation, or any digestive disease/disorder under investigation -Major physical trauma or surgical procedure within the 4 weeks prior to enrolment Pathology abnormalities - Screening pathology testing indicative of clinically significant, liver or kidney dysfunction or full blood count abnormalities (as determined by the PI) - Screening pathology testing of 25-hydroxy-vitamin D less than 30 nmol/L Mental Health / language barriers - Unable to speak or understand English or cannot understand the trial requirements Lifestyle - Current or recent (in last 28 days) alcoholism (>14 standard drinks per week) Medications - Current, regular use of any prescription anti-coagulant or antiplatelet medication (excluding low-dose aspirin). - Current, regular (more than once per week) use of prescription lipid-lowering medication, e.g., statins, fibrates - Current, regular use of any prescription anti-inflammatory medication or frequent (more than twice per week on average) use of over-the-counter NSAIDs - Regular clinically significant use of supplements with anti-inflammatory or antiplatelet activity - Polypharmacy (defined as five or more regular daily prescription medications) for chronic disease/condition management - Clinically significant (as per PI) changes to prescription medication usage within previous three months. - Current use of any supplement containing plasmalogens or seafood extracts including marine oils Other - Pregnant or breast-feeding or unwilling to use contraception during the trial - Unwilling to use effective contraception during the trial - Known, clinically significant allergy or intolerance to seafood, mussels or shellfish - Regularly consuming >200g oily fish (i.e. salmon or tuna) per week - Current or planned adherence to extreme diet restrictions, i.e. ketogenic or very low-fat diet - Any participant for whom trial participation would not be in the participant’s best interest or whose data would have questionable validity, as per PI discretion
Outcome results
None listed