B-vitamins and Omega-3 Fatty Acids and Biomarkers of Brain Atrophy.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention, Control.
- Who it may be relevant to
- Registry conditions: Dementia, Cognitive Function. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
B-vitamins and ω-3 Fatty Acids to Modulate Brain Ageing in European Citizens Through Improved Nutrition: the BOOMERANG Project
Overview
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
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.
Interventions
- 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. - 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)
Primary outcome measures
- Neurofilament light chain (NfL) [Time frame: 3 months]
Secondary outcome measures (4)
- Cognitive function [Time frame: 3 months]
- Change in plasma homocysteine [Time frame: 3 months]
- B-vitamins [Time frame: 3 months]
- Omega-3 [Time frame: 3 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Norway · 1 center
- Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo — Oslo
Identifiers
NCT: NCT07312435 · REK sør-øst A 912838