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

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: t
View:

• Age \> 65 years

• A low baseline B-vitamin status as assessed by plasma tHcy \> 11 μmol/L

• Normal MMSE score (\>25)

Locations
Other Locations
Norway
Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo
RECRUITING
Oslo
Contact Information
Primary
Stine M Ulven, PhD
smulven@medisin.uio.no
+4722840208
Backup
Tahreem G Siddiqui, PhD
tahreems@uio.no
+4722840208
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 96
Treatments
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).
Placebo_comparator: Control
The control group will receive daily supplementation of one placebo pill matching the B-vitamins and one placebo pill matching Lysoveta.
Related Therapeutic Areas
Sponsors
Collaborators: University of Dublin, Trinity College, University of Ulster, Heinrich-Heine University, Duesseldorf, Maastricht University, Aker BioMarine
Leads: University of Oslo

This content was sourced from clinicaltrials.gov