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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Oslo

About this trial

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.

Eligibility criteria

Qualifiers

Age > 65 years

A low baseline B-vitamin status as assessed by plasma tHcy > 11 μmol/L

Normal MMSE score (>25)

Disqualifiers

Unable to give informed consent

Fatty fish intake > 2 times per week

daily omega-3 supplementation

daily B-vitamin supplementation

Trial design

Treatments tested in this trial

  • Intervention
  • Control

Treatment groups

96 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Oslo

Lead sponsor

Maastricht University

Collaborator

University of Dublin, Trinity College

Collaborator

Aker BioMarine

Collaborator

University of Ulster

Collaborator

Heinrich-Heine University, Duesseldorf

Collaborator