DementiaBOOMERANGNCT07312435
B-vitamins and Omega-3 Fatty Acids and Biomarkers of Brain Atrophy.
A study testing Intervention in people with Dementia and Cognitive Function, run by University of Oslo at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Cognitive Function
- What is being tested?
- Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2025to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age > 65 years
- A low baseline B-vitamin status as assessed by plasma tHcy > 11 μmol/L
- Normal MMSE score (>25)
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo
Oslo
Stine Ulven, PhD, +4722840208, smulven@medisin.uio.no
Tahreem G Siddiqui, PhD, +4722840208, tahreems@uio.no
About this study
Official title: B-vitamins and ω-3 Fatty Acids to Modulate Brain Ageing in European Citizens Through Improved Nutrition: the BOOMERANG Project
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.
Read the 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.
- Conditions
- Dementia, Cognitive Function
- Being tested
- Intervention, Control
- Keywords
- Nutrition, Omega3, B vitamins, older adults, cognition
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionDietary 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.
ControlOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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). Receives: Dietary Supplement: Intervention |
| Control | Placebo comparator | The control group will receive daily supplementation of one placebo pill matching the B-vitamins and one placebo pill matching Lysoveta. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (4)
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).
Measured: 3 months
Change in plasma homocysteine
Change in plasma homocysteine
Measured: 3 months
B-vitamins
B-vitamins (B12, folate, B6 and riboflavin)
Measured: 3 months
Omega-3
EPA, DHA, omega-3 index (the percentage of EPA and DHA in red blood cells)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Sep 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University, University of Dublin, Trinity College, Aker BioMarine, University of Ulster, Heinrich-Heine University, Duesseldorf
- Responsible party
- Principal investigator, Stine Marie Ulven, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312435
- Sponsor's protocol ID
- REK sør-øst A 912838
- Acronym
- BOOMERANG
- Status last verified
- Sep 2025
- First submitted
- 16 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not allowed to share IP data due to the Univerity of Oslos data protection and regional ethical comittee rules.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B-vitamins and ω-3 Fatty Acids to Modulate Brain Ageing in European Citizens Through Improved Nutrition: the BOOMERANG Project
- ClinicalTrials.gov ID
- NCT07312435
- Acronym / sponsor ID
- BOOMERANG / REK sør-øst A 912838
- Conditions
- Dementia, Cognitive Function
- Keywords
- Nutrition, Omega3, B vitamins, older adults, cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Maastricht University, University of Dublin, Trinity College, Aker BioMarine, University of Ulster, Heinrich-Heine University, Duesseldorf
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: InterventionThe 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). |
| Control | Placebo comparator | Other: ControlThe control group will receive daily supplementation of one placebo pill matching the B-vitamins and one placebo pill matching Lysoveta. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age > 65 years
- A low baseline B-vitamin status as assessed by plasma tHcy > 11 μmol/L
- Normal MMSE score (>25)
Key exclusion criteria (10 listed)
- Unable to give informed consent
- Fatty fish intake > 2 times per week
- daily omega-3 supplementation
- daily B-vitamin supplementation
- history of B12-injections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionThe 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. | Dietary supplement | Intervention |
| ControlThe 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) | Other | Control |
Primary outcome
Neurofilament light chain (NfL)
Time frame: 3 months
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: No. We are not allowed to share IP data due to the Univerity of Oslos data protection and regional ethical comittee rules.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Dementia and Cognitive Function, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stine M Ulven, PhD (+4722840208, smulven@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurofilament light chain (NfL) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.