Effects of an omega-3 supplement on healthy ageing
Tolerability and Effects of a New Omega-3 Fatty Acid-based Supplement on Clinical and Biological Markers of Healthy Ageing
This study is testing if a new omega-3 supplement can help people aged 55 and older stay healthy as they age by looking at their heart health, muscle strength, and brain function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 55 Years to 100 Years |
| Sex | All |
| Sponsor | Helse Stavanger HF Government |
| Locations | 1 site (Stavanger) |
| Trial ID | NCT06150261 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind placebo-controlled trial aims to evaluate the tolerability and effects of a new omega-3 fatty acid-based supplement on various biological and clinical aspects related to healthy ageing. Participants aged 55 and older will take either the supplement or a placebo for six months, during which they will undergo physical examinations, muscle function tests, cognitive assessments, and provide biological samples. The study seeks to determine if the omega-3 supplement can positively influence factors associated with healthy ageing, such as cardiovascular health, muscle function, and cognitive abilities.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 55 or older with a BMI between 25-30 and a waist-to-hip ratio indicating potential metabolic risk.
Not a fit: Patients with significant cardiovascular diseases, diabetes, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how omega-3 supplementation may enhance healthy ageing and reduce age-related decline.
How similar studies have performed: Other studies have indicated potential benefits of omega-3 fatty acids on health, suggesting this approach may yield promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Stavanger
- Stavanger Universitetssjukehus — Stavanger, Norway (Recruiting)
Study contacts
- Principal investigator: Dag Aarsland, PhD — Helse Stavanger HF
- Study coordinator: Dag Aarsland, PhD
- Email: dag.arsland@sus.no
- Phone: +47 51515062
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.