Actively Recruiting
Effects and Tolerability of a New Omega-3 Fatty Acid Supplement on Clinical and Biological Markers of Healthy Ageing in Adults Aged 55 and Older
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
Researchers are examining the tolerability and effects of a new omega-3 fatty acid-based supplement on biological and clinical factors related to healthy aging. This randomized, double-blind, placebo-controlled trial focuses on adults aged 55 to 100 years with specific health criteria. The study aims to understand how the supplement impacts mental and physical abilities that contribute to wellbeing as people age, including muscle function and brain health. Participants will take either the omega-3 supplement called AvailOm or a placebo, both consisting of 5 capsules taken once daily with the main meal, over a period of six months. The trial is designed with parallel groups to compare the supplement's effects against the placebo. The omega-3 fatty acids in the supplement include EPA and DHA, which are essential nutrients thought to promote healthy aging. During the study, participants will visit the clinic three times to undergo physical exams, muscle function tests, cognitive assessments, and complete questionnaires. Biological samples such as blood, saliva, and feces will be collected. Researchers will monitor adherence and safety while measuring outcomes like changes in DNA methylation and other markers related to aging. The total study duration for each participant is six months.
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
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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