Multivitamin Intervention and Cognitive Function

NCT ID: NCT06795789

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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

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Healthy Adult Cognitive Measures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Vitals+ (combined multivitamin and polyphenol supplement)

Participants to supplement with Vitals+ multivitamin combined polyphenol supplement for 3 months

Group Type EXPERIMENTAL

Vitals+ (combined multivitamin and polyphenol supplement)

Intervention Type DIETARY_SUPPLEMENT

Multivitamin with 19 essential nutrients combined with Bilberry polyphenols

Interventions

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Vitals+ (combined multivitamin and polyphenol supplement)

Multivitamin with 19 essential nutrients combined with Bilberry polyphenols

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Vitals+

Eligibility Criteria

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Inclusion Criteria

* Healthy Men and Women age \>18 years
* Newly subscribed to the nutritional supplement
* Access to a PC or laptop with internet connection

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Braincare Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harry R Jarrett, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Heights

Locations

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Heights Research and Development

London, , United Kingdom

Site Status

Heights Research and Development

London, , United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Harry R Jarrett, Ph.D

Role: CONTACT

020 3540 0354

Lisa Holton, MSc

Role: CONTACT

020 3540 0354

Facility Contacts

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Harry R Jarrett, Ph.D

Role: primary

020 3540 0354

Harry Jarrett, Ph.D

Role: primary

020 3540 0354

Lisa Holton, MS.c

Role: backup

020 3540 0354

Other Identifiers

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Vitals_CF_01

Identifier Type: -

Identifier Source: org_study_id

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