Healthy AdultNCT06795789
Multivitamin Intervention and Cognitive Function
A study testing Vitals+ (combined multivitamin and polyphenol supplement) in people with Healthy Adult and Cognitive Measures, run by Braincare Limited at 2 sites in United Kingdom.
Trial summary
The purpose of this trial is to learn how a multivitamin combined blueberry polyphenol supplement (Vitals+) influences cognitive function in healthy adults. A secondary aim is to see how the biochemical level of nutritional factors change with the supplement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult, Cognitive Measures
- What is being tested?
- Vitals+ (combined multivitamin and polyphenol supplement)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Mar 2025to 1 Dec 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Men and Women age >18 years
- Newly subscribed to the nutritional supplement
- Access to a PC or laptop with internet connection
Who cannot join
- Unable to give informed consent
- Consumed a nutritional supplement in past 3 months
- Consuming > 4 portions of B-vitamin fortified foods a week
- Pregnant or breastfeeding
- Diagnosis of a neurological condition, such as Dementia, depression or anxiety
- Prescribed vitamin B12 injections
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites
Heights Research and Development
London, W1D 2LG
Harry R Jarrett, Ph.D, 020 3540 0354, harry@yourheights.com
Harry R Jarrett, Ph.D
Heights Research and Development
London, W1D 2LG
Harry Jarrett, Ph.D, 020 3540 0354, harry@yourheights.com
Lisa Holton, MS.c, 020 3540 0354, lisa@yourheights.com
About this study
Official title: The Impact of a Multivitamin Combined Blueberry Polyphenol Supplement on Cognitive Function: A Pilot Study
The purpose of this trial is to learn how a multivitamin combined blueberry polyphenol supplement (Vitals+) influences cognitive function in healthy adults. A secondary aim is to see how the biochemical level of nutritional factors change with the supplement.
This study will be completed fully remote (from the participants home without in-person visits). Participants will be asked to compete three steps over the course of 3 months:
Read more
Step 1:
Participants will be asked to complete an online cognitive function game (45 minutes)
Step 2:
Participants will receive a fingertip blood sample kit in the post to measure nutritional markers in the body (requiring 8 drops of blood). They will then be asked to complete the same online cognitive function game and answer some questions about their general health (50 minutes). After this, participants will be requested to start their multivitamin (Vitals+) subscription, once a day for 3 months.
Step 3:
This final step is the same as step 2. After 3 months participants will receive another fingertip blood sample kit in the post (requiring 8 drops of blood) and asked to complete the cognitive function games again (50 minutes). This will mark the end of the study.
How these measurements responded to the multivitamin supplement will then be measured.
Read the detailed description
This study will investigate the influence of a 3 month multivitamin combined blueberry polyphenol supplement (Vitals+) on cognitive function, as measured by a validated online cognitive function test. The secondary outcome of this study is to evaluate nutritional biomarker response to the intervention. Specifically, elevated homocysteine concentrations have been reported as a risk factor for cognitive impairment and Dementia. Significant improvements in biomarker status of B-vitamins involved in homocysteine metabolism were found following intervention with this supplement (Vitals+). Therefore, it is hypothesised that the intervention will lead to reductions in homocysteine levels.
Furthermore, Vitamin D is a nutrient of concern, with deficient or suboptimal biomarker status reported across many European populations (particularly in winter months). Whilst vitamin D intervention has been shown to improve cognitive function in healthy adults. Therefore, a secondary hypothesis is that the supplement will lead to increased Vitamin D biomarker status.
It is hypothesised that any observed changes in cognitive function will be associated with changes in the biomarker response of homocysteine and Vitamin D.
- Conditions
- Healthy Adult, Cognitive Measures
- Being tested
- Vitals+ (combined multivitamin and polyphenol supplement)
- Keywords
- Multivitamin, Polyphenols, Blueberry, Cognitive Function, Homocysteine, B-vitamins, Vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitals+ (combined multivitamin and polyphenol supplement)Dietary supplement
Also called Vitals+
Multivitamin with 19 essential nutrients combined with Bilberry polyphenols
| Study group | Role | What they receive |
|---|---|---|
| Vitals+ (combined multivitamin and polyphenol supplement) | Experimental | Participants to supplement with Vitals+ multivitamin combined polyphenol supplement for 3 months Receives: Dietary Supplement: Vitals+ (combined multivitamin and polyphenol supplement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function
A validated online Cognitive Function test will be used to assess cognition pre-post intervention
Measured: 3 months
Secondary outcomes (2)
Total homocysteine
Total homocysteine concentrations will be measured through blood spot samples by isotopic dilution and high-performance liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS)
Measured: 3 months
Vitamin D
Vitamin D concentrations will be measured through blood spot samples by isotopic dilution and high-performance liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS)
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 posted28 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Braincare Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harry R Jarrett, Ph.D, Principal investigator, Heights
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795789
- Sponsor's protocol ID
- Vitals_CF_01
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Multivitamin Combined Blueberry Polyphenol Supplement on Cognitive Function: A Pilot Study
- ClinicalTrials.gov ID
- NCT06795789
- Acronym / sponsor ID
- Vitals_CF_01
- Conditions
- Healthy Adult, Cognitive Measures
- Keywords
- Multivitamin, Polyphenols, Blueberry, Cognitive Function, Homocysteine, B-vitamins, Vitamin D
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Braincare LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 28 Jan 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.
The purpose of this trial is to learn how a multivitamin combined blueberry polyphenol supplement (Vitals+) influences cognitive function in healthy adults. A secondary aim is to see how the biochemical level of nutritional factors change with the supplement.
This study will be completed fully remote (from the participants home without in-person visits). Participants will be asked to compete three steps over the course of 3 months:
Step 1:
Participants will be asked to complete an online cognitive function game (45 minutes)
Step 2:
Participants will receive a fingertip blood sample kit in the post to measure nutritional markers in the body (requiring 8 drops of blood). They will then be asked to complete the same online cognitive function game and answer some questions about their general health (50 minutes). After this, participants will be requested to start their multivitamin (Vitals+) subscription, once a day for 3 months.
Step 3:
This final step is the same as step 2. After 3 months participants will receive another fingertip blood sample kit in the post (requiring 8 drops of blood) and asked to complete the cognitive function games again (50 minutes). This will mark the end of the study.
How these measurements responded to the multivitamin supplement will then be measured.
Detailed description
This study will investigate the influence of a 3 month multivitamin combined blueberry polyphenol supplement (Vitals+) on cognitive function, as measured by a validated online cognitive function test. The secondary outcome of this study is to evaluate nutritional biomarker response to the intervention. Specifically, elevated homocysteine concentrations have been reported as a risk factor for cognitive impairment and Dementia. Significant improvements in biomarker status of B-vitamins involved in homocysteine metabolism were found following intervention with this supplement (Vitals+). Therefore, it is hypothesised that the intervention will lead to reductions in homocysteine levels.
Furthermore, Vitamin D is a nutrient of concern, with deficient or suboptimal biomarker status reported across many European populations (particularly in winter months). Whilst vitamin D intervention has been shown to improve cognitive function in healthy adults. Therefore, a secondary hypothesis is that the supplement will lead to increased Vitamin D biomarker status.
It is hypothesised that any observed changes in cognitive function will be associated with changes in the biomarker response of homocysteine and Vitamin D.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitals+ (combined multivitamin and polyphenol supplement) | Experimental | Dietary Supplement: Vitals+ (combined multivitamin and polyphenol supplement)Participants to supplement with Vitals+ multivitamin combined polyphenol supplement for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy Men and Women age >18 years
- Newly subscribed to the nutritional supplement
- Access to a PC or laptop with internet connection
Key exclusion criteria (6 listed)
- Unable to give informed consent
- Consumed a nutritional supplement in past 3 months
- Consuming > 4 portions of B-vitamin fortified foods a week
- Pregnant or breastfeeding
- Diagnosis of a neurological condition, such as Dementia, depression or anxiety
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 |
|---|---|---|
| Vitals+ (combined multivitamin and polyphenol supplement)Also: Vitals+Multivitamin with 19 essential nutrients combined with Bilberry polyphenols | Dietary supplement | Vitals+ (combined multivitamin and polyphenol supplement) |
Primary outcome
Cognitive Function
Time frame: 3 months
A validated online Cognitive Function test will be used to assess cognition pre-post intervention
2 secondary outcomes
Total homocysteine
Time frame: 3 months
Vitamin D
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 28 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Harry R Jarrett, Ph.D principal investigator
Heights
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitals+ (combined multivitamin and polyphenol supplement) in people with Healthy Adult and Cognitive Measures, run by Braincare Limited at 2 sites in United Kingdom.
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 6 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: opening soon, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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. 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 Harry R Jarrett, Ph.D (020 3540 0354, harry@yourheights.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function (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 28 Jan 2025.