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Clinical Trial NCT07312435 (BOOMERANG) for Dementia, Cognitive Function is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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B-vitamins and Omega-3 Fatty Acids and Biomarkers of Brain Atrophy. (BOOMERANG) 96 Biomarker-Driven Randomized Double-Blind Dietary

Recruiting
Clinical Trial NCT07312435 (BOOMERANG) is an interventional study for Dementia, Cognitive Function that is recruiting. It started on September 1, 2025 with plans to enroll 96 participants. Led by University of Oslo, it is expected to complete by June 1, 2028. The latest data from ClinicalTrials.gov was last updated on December 31, 2025.
Brief 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 ...Show More
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, ...Show More
Official Title

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

Conditions
DementiaCognitive Function
Other Study IDs
  • BOOMERANG
  • REK sør-øst A 912838
NCT ID Number
NCT07312435
Start Date (Actual)
2025-09-01
Last Update Posted
2025-12-31
Completion Date (Estimated)
2028-06-01
Enrollment (Estimated)
96
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Nutrition
Omega3
B vitamins
older adults
cognition
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalIntervention
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).
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 ComparatorControl
The control group will receive daily supplementation of one placebo pill matching the B-vitamins and one placebo pill matching Lysoveta.
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
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Older Adult
Minimum Age
65 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • Age > 65 years
  • A low baseline B-vitamin status as assessed by plasma tHcy > 11 μmol/L
  • Normal MMSE score (>25)

  • 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.
University of Oslo logoUniversity of Oslo
Study Responsible Party
Stine Marie Ulven, Principal Investigator, Professor, University of Oslo
Study Central Contact
Contact: Stine M Ulven, PhD, +4722840208, [email protected]
Contact: Tahreem G Siddiqui, PhD, +4722840208, [email protected]
1 Study Locations in 1 Countries
Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway
Stine Ulven, PhD, Contact, +4722840208, [email protected]
Tahreem G Siddiqui, PhD, Contact, +4722840208, [email protected]
Stine G Ulven, PhD, Principal Investigator
Tahreem G Siddiqui, PhD, Sub-Investigator
Recruiting