Actively Recruiting
B-vitamins and Omega-3 Fatty Acids to Modulate Brain Ageing in European Citizens Through Improved Nutrition: the BOOMERANG Project
Led by University of Oslo · Updated on 2025-12-31
96
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
Sponsors
U
University of Oslo
Lead Sponsor
M
Maastricht University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the combined effects of B-vitamins and omega-3 fatty acids on brain health in older adults. This study focuses on how these supplements may influence brain atrophy by measuring neurofilament light chain (NfL), a key biomarker linked to brain inflammation, atrophy, and cognitive decline. The study also explores secondary outcomes including changes in blood markers, gene expression, metabolite profiles, quality of life, and cognitive performance. Participants will be randomly assigned to one of two groups. The intervention group receives daily supplements consisting of one pill of B-vitamins (including B12, folate, B6, and riboflavin) plus six pills of Lysoveta, a bioavailable omega-3 fatty acid supplement derived from krill. The control group receives matching placebo pills. The study lasts for three months, during which participants take the supplements daily while remaining blinded to their group assignment. Throughout the study, participants will undergo blood tests to measure biomarkers such as NfL, homocysteine, and omega-3 levels, along with assessments of cognitive function and quality of life using standardized questionnaires. These evaluations help researchers understand the effects of the supplements on brain aging and cognitive health. The total participation time covers the three-month supplementation period and associated assessments.
CONDITIONS
Brief Title
B-vitamins and Omega-3 Fatty Acids and Biomarkers of Brain Atrophy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 65 years
- Low baseline B-vitamin status indicated by plasma homocysteine greater than 11 µmol/L
- Normal cognitive function with MMSE score above 25
You will not qualify if you...
- Unable to give informed consent
- Eating fatty fish more than twice per week
- Daily omega-3 supplementation
- Daily B-vitamin supplementation
- History of B12 injections
- High serum creatinine above 90 µmol/L for women and above 105 µmol/L for men
- Aspirin use
- Renal disease
- Active cancer
- Must agree to stop omega-3 or B-vitamin supplements and wait 12 weeks before screening if previously used
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants take daily supplements of either B-vitamins combined with omega-3 fatty acids or matching placebos to study their effects on biomarkers related to brain aging.
Monthly visits for supplement dispensing and monitoring
Duration - Up to 3 months after treatment
Participants undergo assessments to evaluate changes in cognitive function and biological markers after completing the supplementation period.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo
Oslo, Norway
Actively Recruiting
Research Team
S
Stine M Ulven, PhD
T
Tahreem G Siddiqui, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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