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

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: Recruiting
• Conditions: Dementia; Cognitive Function
• Intervention / Treatment: Dietary supplement: Intervention; Other: Control

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: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stine M Ulven, PhD; Phone Number: +4722840208; Email: smulven@medisin.uio.no
• 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: Stine Ulven, PhD; Phone Number: +4722840208; Email: smulven@medisin.uio.no
    • Contact: Tahreem G Siddiqui, PhD; Phone Number: +4722840208; Email: tahreems@uio.no
    • Principal Investigator: Stine G Ulven, PhD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function	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	Change in plasma homocysteine	3 months
B-vitamins	B-vitamins (B12, folate, B6 and riboflavin)	3 months
Omega-3	EPA, DHA, omega-3 index (the percentage of EPA and DHA in red blood cells)	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological age	Biological age using epigenetic clocks	3 months
Biomarkers of brain atrophy,	p-tau, inflammation,	3 months
Quality of life in older adults	Quality of life RAND SF-36	3 months
Transcriptome PBMC	Biomarker	3 months
Metabolome in plasma	Biomarker	3 months
Gut microbiome	Biomarker	3 months

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: Heinrich-Heine University, Duesseldorf; University of Ulster; Maastricht University; University of Dublin, Trinity College; Aker BioMarine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: older adults; cognition; Nutrition; B vitamins; Omega3
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Investigative Techniques; Methods
• Other Study ID 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