Clinical trial NCT06795789: Multivitamin Intervention and Cognitive Function
Official title: The Impact of a Multivitamin Combined Blueberry Polyphenol Supplement on Cognitive Function: A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Adult
Cognitive Measures
Keywords: Multivitamin
Polyphenols
Blueberry
Cognitive Function
Homocysteine
B-vitamins
Vitamin D
Lead sponsor: Braincare Limited
Sponsor class: INDUSTRY
First posted: 2025-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive Function
timeFrame: 3 months
Secondary outcomes:
measure: Total homocysteine
timeFrame: 3 months
measure: Vitamin D
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Heights Research and Development
city: London
country: United Kingdom
facility: Heights Research and Development
Study officials:
affiliation: Heights
name: Harry R Jarrett, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: