About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age > 65 years
A low baseline B-vitamin status as assessed by plasma tHcy > 11 μmol/L
Normal MMSE score (>25)
Disqualifiers
Unable to give informed consent
Fatty fish intake > 2 times per week
daily omega-3 supplementation
daily B-vitamin supplementation
Trial design
Parallel
Treatments tested in this trial
Intervention
Dietary supplementThe 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
Other interventionThe 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)
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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).
Change in plasma homocysteine
Change in plasma homocysteine
B-vitamins
B-vitamins (B12, folate, B6 and riboflavin)
Omega-3
EPA, DHA, omega-3 index (the percentage of EPA and DHA in red blood cells)
Other outcomes
Biological age
Biological age using epigenetic clocks
Biomarkers of brain atrophy,
p-tau, inflammation,
Quality of life in older adults
Quality of life RAND SF-36
Transcriptome PBMC
Biomarker
Sponsors and contacts
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University of Oslo
Lead sponsor
Maastricht University
Collaborator
University of Dublin, Trinity College
Collaborator
Aker BioMarine
Collaborator
University of Ulster
Collaborator
Heinrich-Heine University, Duesseldorf
Collaborator