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Clinical Trials in Norway / NCT07312435
Recruiting Not applicable

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

NCT07312435 · tracked via the Priya Life Science Norway tracker
Sponsor
University of Oslo
Phase
Not applicable
Started
2025-09-01
Last updated
2025-12-31

Condition(s) studied

DementiaCognitive Function

Investigational drug(s) / intervention(s)

InterventionControl

Intervention: The intervention group will receive daily supplementation of one pill of B-vitamins (0.5 mg B12, 0.8 mg folate, 10 mg B6 and 10 mg riboflavin) + six pills of 500 mg Lysoveta, in total 3 g Lysoveta (480 mg EPA, 240 mg DHA). Lysoveta is an LPC-bound EPA/DHA supplement from krill which Aker BioMarine has recently developed.

Control: The control group will receive daily supplementation of one placebo pill matching the B-vitamins and one placebo pill matching Lysoveta. the placebo capsules will contain 500 mg of mixed vegetable oil (comprising a blend of olive-, maize-, and palm kernel oil and medium-chain triglycerides, in a ratio of 4:4:3:2)

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Age \> 65 years * A low baseline B-vitamin status as assessed by plasma tHcy \> 11 μmol/L * Normal MMSE score (\>25) Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo Oslo Norway Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07312435 on ClinicalTrials.gov ↗ ← All trials in Norway