B-vitamins plus omega-3s to reduce brain atrophy markers
Official title: B-vitamins and ω-3 Fatty Acids to Modulate Brain Ageing in European Citizens Through Improved Nutrition: the BOOMERANG Project
Run by University of Oslo · NCT07312435 · Data updated 2026-11-12
We will test whether taking B‑vitamins together with a highly absorbable omega‑3 supplement lowers a blood marker of brain atrophy in adults over 65 who have low B‑vitamin status.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | University of Oslo Academic / other |
| Locations | 1 site (Oslo) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | March 1, 2027 |
| Study ends | June 1, 2028 |
| Registry record updated | December 31, 2025 |
| Trial ID | NCT07312435 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 65 with low plasma B‑vitamin status (tHcy >11 µmol/L), normal cognitive screening (MMSE >25), low habitual fatty fish intake, and willingness to stop other omega‑3 or B‑vitamin supplements for the study period.
✕Probably not a fit
People already taking daily omega‑3s or B‑vitamin supplements, those who regularly eat fatty fish (>2 times/week), or individuals with advanced cognitive impairment, significant renal disease, or active cancer are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a double‑blind, randomized controlled trial in older adults comparing combined B‑vitamin supplementation plus a highly bioavailable omega‑3 product (Lysoveta) versus control over three months. The primary outcome is change in plasma neurofilament light chain (NfL), a blood biomarker linked to brain atrophy and neurodegeneration. Secondary measures include plasma homocysteine, B‑vitamin and EPA/DHA levels, omega‑3 index, epigenetic biological age, gene expression and metabolite profiles, quality of life (SF‑36), and cognitive performance. Participants must be >65 years old with low baseline B‑vitamin status (tHcy >11 µmol/L) and normal MMSE (>25), and exclusion criteria include frequent fatty fish intake, current omega‑3 or B‑vitamin supplementation, certain renal thresholds, aspirin use, active cancer, and inability to consent.
Why it matters
Potential benefit: If successful, this combined supplement approach could slow biological signs of brain atrophy and potentially translate into preserved cognition or better quality of life for older adults with low B‑vitamin status.
How similar studies have gone: Previous trials of B‑vitamins or omega‑3s alone have shown mixed effects on cognition, and post‑hoc and experimental work suggests possible synergy, but this exact combined intervention has not been directly tested in humans before.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo
Oslo, Norway Recruiting
Study contacts
- Study coordinator: Stine M Ulven, PhD
- Email: smulven@medisin.uio.no
- Phone: +4722840208
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.