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

December 16, 2025 updated by: Stine Marie Ulven, University of Oslo

B-vitamins and ω-3 Fatty Acids to Modulate Brain Ageing in European Citizens Through Improved Nutrition: the BOOMERANG Project

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Tahreem G Siddiqui, PhD
  • Phone Number: +47 +4722840208
  • Email: tahreems@uio.no

Study Locations

  • Norway
      • Oslo, Norway
        • Recruiting
        • Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo
        • Sub-Investigator:
          • Tahreem G Siddiqui, PhD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stine G Ulven, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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).
Dietary supplement: 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.
Placebo Comparator: Control
The control group will receive daily supplementation of one placebo pill matching the B-vitamins and one placebo pill matching Lysoveta.
Other: 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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Neurofilament light chain (NfL)
Time Frame: 3 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cognitive function
Time Frame: 3 months
Neuropsychological tests of global and domain specific cognitive functions will be assessed using a test battery that includes the Mini-Mental state Examination, Cognistat, and Cerad test battery (working memory, verbal fluency, constructional praxis).
3 months
Change in plasma homocysteine
Time Frame: 3 months
Change in plasma homocysteine
3 months
B-vitamins
Time Frame: 3 months
B-vitamins (B12, folate, B6 and riboflavin)
3 months
Omega-3
Time Frame: 3 months
EPA, DHA, omega-3 index (the percentage of EPA and DHA in red blood cells)
3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Biological age
Time Frame: 3 months
Biological age using epigenetic clocks
3 months
Biomarkers of brain atrophy,
Time Frame: 3 months
p-tau, inflammation,
3 months
Quality of life in older adults
Time Frame: 3 months
Quality of life RAND SF-36
3 months
Transcriptome PBMC
Time Frame: 3 months
Biomarker
3 months
Metabolome in plasma
Time Frame: 3 months
Biomarker
3 months
Gut microbiome
Time Frame: 3 months
Biomarker
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oslo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Heinrich-Heine University, Duesseldorf
University of Ulster
Maastricht University
University of Dublin, Trinity College
Aker BioMarine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REK sør-øst A 912838

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We are not allowed to share IP data due to the Univerity of Oslos data protection and regional ethical comittee rules.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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