Multivitamin Intervention and Cognitive Function

Braincare Limited

Status: Not yet enrolling

Conditions: Cognitive Measures; Healthy Adult

Treatments: Dietary Supplement: Vitals+ (combined multivitamin and polyphenol supplement)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06795789

Vitals_CF_01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Vitals+ (combined multivitamin and polyphenol supplement)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Vitals+ (combined multivitamin and polyphenol supplement)