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

Trial Summary

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.

What data supports the effectiveness of the treatment Cognitive Nutritional Supplement for cognition?

Research shows that certain components of nutritional supplements, like B-vitamins, can improve cognitive function in older adults, especially those with mild cognitive impairment. Additionally, a specific nutriceutical formulation has been shown to enhance memory and cognitive performance in adults without dementia. ^{1 2 3 4 5}

Is the Cognitive Nutritional Supplement generally safe for humans?

There are safety concerns with herbal dietary supplements used for cognitive enhancement, as reports indicate serious adverse reactions, including skin and heart issues, and liver problems. Additionally, some supplements may not contain the ingredients listed on their labels, which could pose risks to users. ^{2 6 7 8 9}

How does the Cognitive Nutritional Supplement treatment differ from other treatments for cognitive function?

The Cognitive Nutritional Supplement treatment is unique because it combines specific dietary components like cocoa extract, which contains flavanols, and multivitamins, which are being studied for their potential to improve cognitive function. Unlike standard treatments, this approach focuses on using natural ingredients to support brain health, although evidence on their effectiveness is still mixed. ^{1 5 10 11 12}

What is the purpose of this trial?

This is a double-blind, randomized, 12-week parallel study that aims to determine the effects of a cognitive nutritional supplement for 12 weeks on cognition parameters specific to attention/focus related domains, compared to a placebo control, in a general population of adult men and women in the United States.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

The Essentials of a Global Index for Cognitive Function. [2020]

2. England 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. [2019]

3. France pubmed.ncbi.nlm.nih.gov

A vitamin/nutriceutical formulation improves memory and cognitive performance in community-dwelling adults without dementia. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Three-week nutritional supplementation effect on long-term nutritional status of patients with mild Alzheimer disease. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of cocoa extract and a multivitamin on cognitive function: A randomized clinical trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Use of dietary supplements for cognitive health: results of a national survey of adults in the United States. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Cognitex supplementation in elderly adults with memory complaints: an uncontrolled open label trial. [2017]

8. England pubmed.ncbi.nlm.nih.gov

Suspected adverse reactions to performance enhancing dietary supplements: Spontaneous reports from the Italian phytovigilance system. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

A Public Health Issue: Dietary Supplements Promoted for Brain Health and Cognitive Performance. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Dietary Supplement Ingredients for Optimizing Cognitive Performance Among Healthy Adults: A Systematic Review. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Vitamin B-12 malabsorption and renal function are critical considerations in studies of folate and vitamin B-12 interactions in cognitive performance: NHANES 2011-2014. [2023]

12. Netherlands pubmed.ncbi.nlm.nih.gov

The effects of multivitamins on cognitive performance: a systematic review and meta-analysis. [2018]