Clinical Trial

B-vitamins and Omega-3 Fatty Acids and Biomarkers of Brain Atrophy.

Study acronym: BOOMERANG
Recruiting
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Summary
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.
Trial Details
NCT Number NCT07312435
Lead Sponsor University of Oslo
Collaborators: Maastricht University, University of Dublin, Trinity College, Aker BioMarine, University of Ulster, Heinrich-Heine University, Duesseldorf
Conditions Dementia, Cognitive Function
Enrollment 96 participants
Start Date 2025-09-01
Primary Completion 2027-03-01 (estimated)
Study Completion 2028-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-31