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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Oslo

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Intervention

    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

    Other intervention

    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)

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
3 months

Secondary outcomes

1

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).

Time frame
3 months
2

Change in plasma homocysteine

Change in plasma homocysteine

Time frame
3 months
3

B-vitamins

B-vitamins (B12, folate, B6 and riboflavin)

Time frame
3 months
4

Omega-3

EPA, DHA, omega-3 index (the percentage of EPA and DHA in red blood cells)

Time frame
3 months

Other outcomes

1

Biological age

Biological age using epigenetic clocks

Time frame
3 months
2

Biomarkers of brain atrophy,

p-tau, inflammation,

Time frame
3 months
3

Quality of life in older adults

Quality of life RAND SF-36

Time frame
3 months
4

Transcriptome PBMC

Biomarker

Time frame
3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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