Effects of an Omega-3 Fatty Acid-based Supplement on Healthy Ageing
Tolerability and Effects of a New Omega-3 Fatty Acid-based Supplement on Clinical and Biological Markers of Healthy Ageing
Helse Stavanger HF
100 participants
Dec 8, 2023
INTERVENTIONAL
Conditions
Summary
The goal of this randomised, double-blind placebo controlled trial is to explore tolerability and the effects of a new omega-3 fatty acid-based supplement on biological and clinical aspects relevant for healthy ageing. Participants will be asked to take a supplement or a placebo for 6 months, and to attend the clinic a total of 3 times and to perform or submit the following: * Physical examination * Muscle function tests * Cognitive testing * Questionnaire completion * Biological samples, including blood, saliva and faeces. Researchers will compare the results from the group taking the supplement to the results of the group taking a placebo to see if the supplement has an effect on biological and clinical aspects associated with healthy ageing.
Eligibility
Inclusion Criteria4
- Aged 55 or more
- BMI between 25-30,
- Waist-to-hip ratio of at least 0.90 (males) or 0.85 (females)
- Omega-3 index \<6
Exclusion Criteria21
- Dementia
- Current clinically significant depression, i.e. major depression or GDS 15 score \>7
- Ischemic or haemorrhagic Stroke
- Acute myocardial infarction
- Any form of clinically significant atherosclerotic cardiovascular disease
- Unstable angina pectoris
- Hearth failure in need of treatment
- Diabetes mellitus type 1 or 2
- Clinically relevant kidney diseases that require dialysis, including clinically significant chronic kidney disease
- Liver cirrhosis or active hepatitis B or C
- Cancer of any kind; however, benign tumours are no exclusion criterium
- Clinically relevant inflammatory or autoimmune disorders with history of hospitalisation
- Any form of systemic lupus erythematosus (SLE), rheumatoid arthritis, Colitis ulcerosa, Crohn's disease, Morbus Parkinson, Multiple Sclerosis
- hsCRP \> 3.0 mg/L to exclude high risk individuals according to international criteria
- LDL-C \> 160mg/dL to exclude individuals with high risk for arterioscleratic coronary disease26
- HBa1C \< 6.5% to exclude diabetes
- Fasting Triglycerides \>200 mg/dL
- Omega 3 index \> 6 % (as they may not show any benefit from supplementation)
- Use of fish oil / omega 3 supplements over the last 6 months
- Fish allergy
- Antibiotic use in the last 24 weeks
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Interventions
5 capsules taken once daily with main meal
5 capsules taken once daily with main meal
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06150261