NCT07312435 B-vitamins and Omega-3 Fatty Acids and Biomarkers of Brain Atrophy.
| NCT ID | NCT07312435 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oslo |
| Condition | Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 96 participants in total. It began in 2025-09-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07312435 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07312435 currently recruiting?
Yes, NCT07312435 is actively recruiting participants. Contact the research team at smulven@medisin.uio.no for enrollment information.
Where is the NCT07312435 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT07312435 clinical trial?
NCT07312435 is sponsored by University of Oslo. The trial plans to enroll 96 participants.