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

NCT07312435 | Recruiting

• 1 other identifier: REK sør-øst A 912838
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Function; Dementia

Keywords

Nutrition; Omega3; B vitamins; older adults; cognition

Outcome Measures

Primary Outcomes (1)

• Neurofilament light chain (NfL)

  To assess the effects of combined supplementation of B-vitamins and omega-3 fatty acids on neurofilament light chain (NfL), a biomarker of brain atrophy in a group of elderly

  3 months

Secondary Outcomes (4)

• Cognitive function

  3 months

• Change in plasma homocysteine

  3 months

• B-vitamins

  3 months

• Omega-3

  3 months

Other Outcomes (6)

• Biological age

  3 months

• Biomarkers of brain atrophy,

  3 months

• Quality of life in older adults

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

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).

Dietary Supplement: Intervention

Control

PLACEBO COMPARATOR

The control group will receive daily supplementation of one placebo pill matching the B-vitamins and one placebo pill matching Lysoveta.

Other: Control

Interventions

Intervention DIETARY_SUPPLEMENT

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.

Intervention

Control OTHER

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)

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age \> 65 years
• A low baseline B-vitamin status as assessed by plasma tHcy \> 11 μmol/L
• Normal MMSE score (\>25)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University: collaborator
• University of Dublin, Trinity College: collaborator
• Aker BioMarine: collaborator
• University of Ulster: collaborator
• Heinrich-Heine University, Duesseldorf: collaborator
• University of Oslo: lead

Study Sites (1)

Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Dementia

Interventions

Methods

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Stine M Ulven, PhD

CONTACT

+4722840208; smulven@medisin.uio.no

Tahreem G Siddiqui, PhD

CONTACT

+4722840208; tahreems@uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 31, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 31, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)