Multivitamin Intervention and Cognitive Function

January 27, 2025 updated by: Braincare Limited

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:

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, W1D 2LG
        • Heights Research and Development
        • Principal Investigator:
          • Harry R Jarrett, Ph.D
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitals+ (combined multivitamin and polyphenol supplement)
Participants to supplement with Vitals+ multivitamin combined polyphenol supplement for 3 months
Dietary supplement: Vitals+ (combined multivitamin and polyphenol supplement)
Multivitamin with 19 essential nutrients combined with Bilberry polyphenols
Other Names:
  • Vitals+

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Function
Time Frame: 3 months
A validated online Cognitive Function test will be used to assess cognition pre-post intervention
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total homocysteine
Time Frame: 3 months
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)
3 months
Vitamin D
Time Frame: 3 months
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)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Braincare Limited

Investigators

  • Principal Investigator: Harry R Jarrett, Ph.D, Heights

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Vitals_CF_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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