B-vitamins and Omega-3 Fatty Acids and Biomarkers of Brain Atrophy.
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Dementia, Cognitive Function
In brief
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.
Key facts
- Study ID
- NCT07312435
- Run by
- University of Oslo
- People needed
- 96
- Starts
- 2025-09-01
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2025-12-31
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age > 65 years
- A low baseline B-vitamin status as assessed by plasma tHcy > 11 μmol/L
- Normal MMSE score (>25)
You may not qualify if…
- Unable to give informed consent
- Fatty fish intake > 2 times per week
- daily omega-3 supplementation
- daily B-vitamin supplementation
- history of B12-injections
- Serum creatinine > 90 μmol/L for women and > 105 μmol/L for men (above reference values)
- aspirin use
- renal disease
- active cancer
- Participants can be included if they accept to not take omega-3 supplementation or B-vitamin supplements during the study. They should stop using it and wait 12 weeks before they are invited to a screening visit.
Where it is running
- Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo — Oslo, Norway (enrolling)
Full record on ClinicalTrials.gov
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