Actively Recruiting
B-vitamins and Omega-3 Fatty Acids and Biomarkers of Brain Atrophy.
Led by University of Oslo · Updated on 2025-12-31
96
Participants Needed
1
Research Sites
143 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
A poor nutrition status is a modifiable risk factor for cognitive decline and dementia. In particular, evidence links low status of certain B-vitamins and ω-3 fatty acids (ω-3 FA) with a greater risk of cognitive decline and dementia. Although these dietary components are typically investigated separately, post-hoc analyses of existing clinical trial data and experimental work indicate that B-vitamins and ω-3 FA may exert synergistic beneficial effects on processes related to brain health and cognition. However, this combination has not been tested directly in humans. In the proposed BOOMERANG project, we will study the effects of jointly supplementing with B-vitamins and a highly bioavailable ω-3 FA supplement, Lysoveta, on a robust biomarker of brain atrophy, the neurofilament light chain, in a double-blinded randomized controlled trial (RCT) over 3 months in older adults. We will also examine the secondary effects of the supplement of quality of life and cognitive function.
CONDITIONS
Official Title
B-vitamins and Omega-3 Fatty Acids and Biomarkers of Brain Atrophy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 65 years
- Low baseline B-vitamin status as shown by plasma homocysteine > 11 bcmol/L
- Normal cognitive function with Mini-Mental State Examination score > 25
You will not qualify if you...
- Unable to give informed consent
- Fatty fish intake more than 2 times per week
- Daily omega-3 supplementation
- Daily B-vitamin supplementation
- History of B12 injections
- Serum creatinine > 90 bcmol/L for women or > 105 bcmol/L for men
- Aspirin use
- Renal disease
- Active cancer
- Participants must agree not to take omega-3 or B-vitamin supplements during the study and wait 12 weeks after stopping before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
T
Tahreem G Siddiqui, PhD
CONTACT
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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