Status:
RECRUITING
Effects of an Omega-3 Fatty Acid-based Supplement on Healthy Ageing
Lead Sponsor:
Helse Stavanger HF
Collaborating Sponsors:
Evonik Industries AG
Conditions:
Healthy Aging
Ageing Well
Eligibility:
All Genders
55-100 years
Phase:
NA
Brief 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 f...
Detailed Description
Healthy ageing is the process of developing and maintaining the functional ability that is associated with wellbeing across the life course and comprises mental and physical capacities such as the abi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06150261
Start Date
December 8 2023
End Date
December 31 2025
Last Update
January 14 2025
Active Locations (1)
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1
Stavanger Universitetssjukehus
Stavanger, Norway