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

NCT ID: NCT07312435

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2028-06-01

Brief Summary

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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.

Detailed Description

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We will 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 older adults. The primary outcome is the change in plasma NfL, which is a marker related to inflammation, brain atrophy, and worsening of cognitive performance. The secondary outcomes are related to change in plasma homocysteine, B-vitamins, EPA, DHA, omega-3 index (the percentage of EPA and DHA in red blood cells), and biological age using epigenetic markers. These are biomarkers that can tell us about the effect of the supplement in the body. We also want to study the effect of the intervention on gene expression profiles and metabolite profiles. In addition, we will include secondary outcome measures of quality of life (SF-36) that include affective symptoms, as these can be a forerunner to developing cognitive impairment. We are also collecting data on their cognitive performance, as this is related to brain atrophy and neurological conditions.

Conditions

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Dementia Cognitive Function

Keywords

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Nutrition Omega3 B vitamins older adults cognition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Intervention

Intervention Type 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.

Control

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type 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)

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oslo

OTHER

Sponsor Role lead

Maastricht University

OTHER

Sponsor Role collaborator

University of Dublin, Trinity College

OTHER

Sponsor Role collaborator

Aker BioMarine

UNKNOWN

Sponsor Role collaborator

University of Ulster

OTHER

Sponsor Role collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role collaborator

Responsible Party

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Stine Marie Ulven

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Stine M Ulven, PhD

Role: CONTACT

Phone: +4722840208

Email: [email protected]

Tahreem G Siddiqui, PhD

Role: CONTACT

Phone: +4722840208

Email: [email protected]

Facility Contacts

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Stine Ulven, PhD

Role: primary

Tahreem G Siddiqui, PhD

Role: backup

Other Identifiers

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REK sør-øst A 912838

Identifier Type: -

Identifier Source: org_study_id