Multivitamin Intervention and Cognitive Function
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vitals+ (combined multivitamin and polyphenol supplement).
- Who it may be relevant to
- Registry conditions: Healthy Adult, Cognitive Measures. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Impact of a Multivitamin Combined Blueberry Polyphenol Supplement on Cognitive Function: A Pilot Study
Overview
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.
Interventions
- Dietary supplement Vitals+ (combined multivitamin and polyphenol supplement)
Multivitamin with 19 essential nutrients combined with Bilberry polyphenols
Primary outcome measures
- Cognitive Function [Time frame: 3 months]
Secondary outcome measures (2)
- Total homocysteine [Time frame: 3 months]
- Vitamin D [Time frame: 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United Kingdom · 2 centers
- Heights Research and Development — London
- Heights Research and Development — London
Identifiers
NCT: NCT06795789 · Vitals_CF_01