Actively Recruiting
Effects of an Omega-3 Fatty Acid-based Supplement on Healthy Ageing
Led by Helse Stavanger HF · Updated on 2025-01-14
100
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
Sponsors
H
Helse Stavanger HF
Lead Sponsor
E
Evonik Industries AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of an Omega-3 Fatty Acid-based Supplement on Healthy Ageing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 55 or more
- BMI between 25 and 30
- Waist-to-hip ratio of at least 0.90 for males or 0.85 for females
- Omega-3 index less than 6
You will not qualify if you...
- Dementia
- Current clinically significant depression (major depression or GDS 15 score greater than 7)
- Ischemic or hemorrhagic stroke
- Acute myocardial infarction
- Any clinically significant atherosclerotic cardiovascular disease
- Unstable angina pectoris
- Heart failure requiring treatment
- Type 1 or type 2 diabetes mellitus
- Clinically relevant kidney diseases requiring dialysis, including chronic kidney disease
- Liver cirrhosis or active hepatitis B or C
- Any cancer except benign tumors
- Clinically relevant inflammatory or autoimmune disorders with hospitalization history
- Systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, Parkinson's disease, or multiple sclerosis
- High hsCRP levels above 3.0 mg/L
- LDL cholesterol above 160 mg/dL
- Hemoglobin A1C below 6.5% to exclude diabetes
- Fasting triglycerides above 200 mg/dL
- Omega-3 index above 6%
- Use of fish oil or omega-3 supplements in the last 6 months
- Fish allergy
- Antibiotic use in the last 24 weeks
AI-Screening
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Trial Site Locations
Total: 1 location
1
Stavanger Universitetssjukehus
Stavanger, Norway
Actively Recruiting
Research Team
D
Dag Aarsland, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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