Cognitive Nutritional Supplement for Cognition

Overseen By Elizabeth A Antoo, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pharmavite LLC

Must not be taking: Antidepressants, ADHD medications

Disqualifiers: Neurological disorders, Mental health disorders, Cancer, Pregnancy, others

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

422 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new nutritional supplement to determine if it can improve attention and focus over 12 weeks. Participants will receive either the cognitive nutritional supplement or a placebo (a pill with no active ingredients) for comparison. It suits adults in the U.S. without neurological or mental health disorders who can follow simple instructions, such as using an iPad and taking capsules daily. Volunteers should also avoid tobacco and nicotine products and maintain a stable daily routine. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in cognitive health.

Will I have to stop taking my current medications?

Yes, if you are currently using medications for mental health disorders or ADHD, you will need to stop taking them to participate in this trial. You can continue taking a regular multivitamin, but other dietary supplements must be stopped during the screening period.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the safety of brain health supplements remains uncertain. Some studies have identified side effects such as headaches, nausea, upset stomach, diarrhea, dizziness, and skin reactions, though these are usually mild. Dietary supplements do not undergo the same rigorous FDA testing as medicines, so some ingredients might lack thorough research. While some evidence suggests these supplements could benefit brain health, the overall safety evidence is weak. Consulting a healthcare provider before starting any new supplement is essential. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike other treatments for cognitive decline that often rely on pharmaceuticals, the Cognitive Nutritional Supplement offers a unique approach by using a blend of nutrients specifically targeting brain health. Researchers are excited because this supplement is designed to enhance cognitive function through a natural mechanism, potentially reducing the risk of side effects common with conventional medications. This treatment could provide a safer, more holistic alternative to standard cognitive enhancers, appealing to individuals seeking non-pharmaceutical options.

What evidence suggests that this cognitive nutritional supplement might be an effective treatment for cognition?

Research has shown that nutritional supplements can enhance brain functions such as memory and attention. One study found that a daily multivitamin slowed brain aging by about two years compared to a placebo. Other research suggests that supplements with multiple nutrients can boost brain development. Reviews highlight that nutrients, especially those providing energy and active ingredients, support brain health throughout life. These findings suggest that the cognitive nutritional supplement under study in this trial might improve attention and focus. Participants will receive either the cognitive nutritional supplement or a placebo to evaluate its effectiveness. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adult men and women in the general US population who are interested in improving attention, focus, or cognition. Specific eligibility criteria details were not provided.

Inclusion Criteria

Willing to refrain from exclusionary medications, supplements, and products throughout the study

English is the primary spoken language

Willing to review and follow all training materials provided

Exclusion Criteria

Color blindness or uncorrectable visual impairments

Use of exclusionary dietary supplements during the study period

I have been diagnosed with depression or an anxiety disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a cognitive nutritional supplement or placebo for 12 weeks to assess cognitive effects

12 weeks

3 visits (in-person) at Week 0, Week 6, and Week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Nutritional Supplement

Trial Overview The study tests a cognitive nutritional supplement's effects on attention and cognition over 12 weeks against a placebo. Participants won't know which one they're taking (double-blind) and will be randomly assigned to either group.

How Is the Trial Designed?

Group I: Placebo Active Control 1 Intervention

Intervention is pills of matching placebo

Group II: Cognitive Nutritional Supplement Placebo Group 1 Intervention

Intervention is pills of cognitive nutrient

Who Is Running the Clinical Trial?

Pharmavite LLC

Lead Sponsor

Trials

12

Recruited

27,200+

BioFortis

Collaborator

Trials

39

Recruited

4,800+

Balchem Corporation

Industry Sponsor

Trials

4

Recruited

2,000+

Biofortis, Inc. (a Mérieux NutriSciences company)

Collaborator

Published Research Related to This Trial

A 3-week nutritional supplementation significantly improved the nutritional status of undernourished patients with mild Alzheimer's disease, as indicated by a notable increase in the Mini Nutritional Assessment (MNA) score.

These improvements were not only immediate but also sustained over a 90-day follow-up period, suggesting that short-term nutritional interventions can have lasting benefits for Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-week nutritional supplementation effect on long-term nutritional status of patients with mild Alzheimer disease. de Sousa, OL., Amaral, TF.[2015]

A systematic review of 25 studies involving older adults (mean age ≥65 years) found that while some B-vitamin supplements showed cognitive benefits, the overall evidence for nutraceuticals improving cognition is not compelling, with only five studies demonstrating notable effects.

Specifically, B-vitamins were linked to improved cognitive function in certain populations, such as those with high homocysteine levels or higher baseline n-3 fatty acid status, but more research is needed to explore interactions with lifestyle and genetic factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of long-term nutraceutical and dietary supplement use on cognition in the elderly: a 10-year systematic review of randomised controlled trials. D'Cunha, NM., Georgousopoulou, EN., Dadigamuwage, L., et al.[2019]

A study analyzing 110 reports of adverse reactions to herbal dietary supplements in Italy found that 23 serious reactions occurred, with 21 requiring hospitalization, highlighting significant safety concerns regarding these products.

Dermatological and cardiovascular issues were the most common reactions, and 9 out of 10 serious hepatic reactions were reported, indicating that the quality and supervision of these supplements are critical for consumer safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suspected adverse reactions to performance enhancing dietary supplements: Spontaneous reports from the Italian phytovigilance system. Ippoliti, I., Menniti-Ippolito, F., Mazzanti, G., et al.[2021]

A review of 12 dietary supplements marketed for brain health revealed that 67% had ingredients listed on their labels that were not detected in the actual product, indicating potential misbranding.

Additionally, 83% of the products contained compounds that were not reported on the labels, and many scientific claims made by these products lacked scientific support, highlighting the need for consumer education and regulatory improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Public Health Issue: Dietary Supplements Promoted for Brain Health and Cognitive Performance. Crawford, C., Boyd, C., Avula, B., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10746024/

Improving Cognitive Function with Nutritional Supplements in ... This review focuses on outcomes such as memory enhancement, attention improvement, executive function support, and neuroprotection.

2. massgeneralbrigham.org massgeneralbrigham.org/en/about/newsroom/press-releases/multivitamins-improve-memory-and-slow-cognitive-aging

Third Major Study Finds Evidence that Daily Multivitamin ... The authors estimate that the daily multivitamin slowed global cognitive aging by the equivalent of two years compared to placebo. “Cognitive ...

3. nature.com nature.com/articles/s41598-017-11023-4

Impact of nutritional supplements on cognitive ... Childhood nutritional supplementation could improve children's cognitive development (d 0.08, 95% CI 0.03–0.13) and those with ≥5 nutrients was ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772408524001376

The dynamic influence of nutrition on prolonged cognitive ... This review explores the impact of nutrition, specifically energy and bioactive components, on cognitive health across different life stages.

5. jgerontology-geriatrics.com jgerontology-geriatrics.com/article/download/109/141

Effectiveness of a specific nutritional supplement on cognitive The results confirmed the data from RCT about the effectiveness of dietary supplementation with a medical food on cognitive symptoms of AD and MCI and also ...

6. nccih.nih.gov nccih.nih.gov/health/providers/digest/dietary-supplements-and-cognitive-function-dementia-and-alzheimers-disease-science

Dietary Supplements and Cognitive Function, Dementia, and ... Safety. Side effects of ginkgo supplements may include headache, nausea, gastrointestinal upset, diarrhea, dizziness, or allergic skin reactions. More severe ...

7. uspharmacist.com uspharmacist.com/article/examining-the-safety-of-brainhealth-enhancers

Examining the Safety of Brain-Health Enhancers Of concern, 67% of the products analyzed had at least one ingredient listed on the Supplement Facts label that was not detected through the ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40077790/

Exploring the Efficacy and Safety of Nutritional ... The growing body of evidence suggests that some supplements may help reduce cognitive decline, inflammation, and target mechanisms behind AD.

9. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-023-02301-6

A systematic review of the safety and efficacy on cognitive ... This review found that there is a low quality of evidence regarding the efficacy of cognitive function and safety of herbal and nutritional medicines for older ...

10. alzdiscovery.org alzdiscovery.org/cognitive-vitality/blog/watch-out-for-brain-health-pseudomedicine

Watch Out for Brain Health Pseudomedicine It is important to remember that dietary supplements are not tested for safety or efficacy by the FDA like drugs are. And, just because a ...