Effects of an Omega-3 Fatty Acid-based Supplement on Healthy Ageing

Launched by HELSE STAVANGER HF · Nov 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a new omega-3 fatty acid-based supplement on healthy aging. Researchers want to see if this supplement can help improve aspects of health as people get older. To do this, they will compare results from participants taking the supplement with those taking a placebo, which looks like the supplement but doesn’t contain any active ingredients. Participants will need to be at least 55 years old, have a body mass index (BMI) between 25 and 30, and have a waist-to-hip ratio above certain levels. They should also have a low omega-3 index, which is a measure of omega-3 levels in the body.

If you join the trial, you will take the supplement or placebo for six months and visit the clinic three times during that period. At these visits, you will undergo physical exams, muscle function tests, cognitive tests (to evaluate your thinking skills), and complete questionnaires. You will also provide biological samples like blood and saliva. This study is currently looking for participants, so if you meet the eligibility criteria and are interested in helping with this important research, consider getting involved!

Gender

ALL

Eligibility 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