Brain Edge for Cognitive Health

Overseen By David Graham, PSM

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Nature's Sunshine Products, Inc.

Must not be taking: Stimulants, Anxiolytics

Disqualifiers: Pregnancy, Neurological conditions, Cardiovascular disease, Serious mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 2 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a supplement called Brain Edge, composed of herbs and amino acids, affects cognitive performance. Participants will receive different combinations of Brain Edge and a placebo (a substance with no active ingredients) over three sessions. Their mental abilities will be evaluated through computer tests, surveys, and virtual reality exercises. The trial is designed for healthy adults who are willing to maintain a consistent lifestyle during the study. As an unphased trial, it offers participants the opportunity to contribute to innovative research on cognitive enhancement.

Will I have to stop taking my current medications?

Yes, you will need to maintain a consistent medication routine throughout the study. If you've changed any prescription or non-prescription medications within 7 days before the study starts, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that many brain supplements, such as Brain Edge, often lack long-term safety information due to less stringent regulation compared to medicines. Quality issues can arise with these products. However, less regulation does not necessarily mean they are unsafe.

Specific information about Brain Edge's side effects or safety is unavailable, leaving uncertainty about its tolerability. Generally, brain supplements may cause mild side effects like upset stomach or headaches, but these can vary among individuals.

When considering participation in a study like this, it's important to weigh the potential benefits against the unknowns about safety. If Brain Edge resembles other brain supplements, most people might tolerate it well, but consulting a healthcare professional about any concerns is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Brain Edge because it offers a new approach to enhancing cognitive health, which is different from standard treatments like cognitive behavioral therapy or prescription medications such as donepezil. Unlike these existing options that often take weeks to show effectiveness, Brain Edge could potentially deliver noticeable results much faster. Additionally, while traditional treatments generally focus on managing symptoms or slowing cognitive decline, Brain Edge might offer a novel mechanism by directly boosting cognitive performance. This fresh angle on cognitive health has the potential to reshape how we think about enhancing brain function.

What evidence suggests that Brain Edge might be an effective treatment for cognitive health?

Research shows that Brain Edge, a supplement made from herbs and amino acids, might help improve thinking skills. Participants in earlier studies demonstrated better memory, reasoning, and processing abilities over time. This trial will test Brain Edge in two sequences: one group will receive Brain Edge first, followed by a placebo, while another group will receive the placebo first, followed by Brain Edge. Although few studies focus specifically on Brain Edge, research has linked its ingredients to brain benefits. These findings suggest that Brain Edge might sharpen the mind and support overall brain health. ^{1 6 7 8 9}

Who Is on the Research Team?

Joseph Lamb, MD

Principal Investigator

Nature's Sunshine Products, Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adults interested in the cognitive effects of a supplement called Brain Edge, which targets depression and cognitive health. Specific eligibility criteria are not provided.

Inclusion Criteria

Generally healthy

Ability to understand and willingness to follow study procedures

I am willing to keep my diet, medications, vitamins, and lifestyle the same during the study.

Exclusion Criteria

Serious, unstable illnesses in various medical domains

Concurrent conditions that may preclude safe participation in the study or interfere with compliance

Any medical, psychiatric, or social reason that may preclude safe participation in the study or interfere with compliance

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Baseline Assessment

Participants are familiarized with cognitive tests and baseline performance values are established

1 day

1 visit (in-person)

Treatment

Participants undergo cognitive testing and receive either Brain Edge or placebo in a double-blind manner

2 days

2 visits (in-person)

Follow-up

Participants are monitored for adverse events and complete a final survey

7 days

What Are the Treatments Tested in This Trial?

Interventions

• Brain Edge

Trial Overview The study tests Brain Edge against water and a placebo in a double-blind setup where neither participants nor researchers know who gets what. It's done over three sessions using computer software, surveys, and VR to measure cognition.

How Is the Trial Designed?

Group I: Crossover Arm 2: Placebo then Brain Edge Experimental Treatment 3 Interventions

Participants will receive Water during visit 1, the Placebo during Visit 2, and Brain Edge during Visit 3

Group II: Crossover Arm 1: Brain Edge then Placebo Experimental Treatment 3 Interventions

Participants will receive Water during Visit 1, Brain Edge during Visit 2, and the Placebo on Visit 3

Who Is Running the Clinical Trial?

Nature's Sunshine Products, Inc.

Lead Sponsor

Trials

4

Recruited

150+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07018674

NCT07018674 | Acute Cognitive Effects of Brain Edge A double-blind placebo-controlled crossover study exploring the cognitive effects of Brain Edge; a supplement consisting of a blend of herbs ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4822500/

Brain Health: The Importance of Recognizing Cognitive ... Participants in this intervention showed improvement in memory, reasoning, and processing even after 5 years of follow-up, although transfer of cognitive ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1386505623002885

Brain health scores to predict neurological outcomes from ... Simple risk scores derived from routinely collected EHR accurately quantify the risk of developing common neurologic and psychiatric diseases.

4. abbeyneuropsychologyclinic.com abbeyneuropsychologyclinic.com/cognitive-edge/

Cognitive Edge Cognitive Edge offers a comprehensive program designed to enhance cognitive abilities through scientifically-backed methods.

5. nature.com nature.com/articles/s41598-023-37128-7

Decoding information about cognitive health from the ... Sleep electroencephalogram (EEG) signals likely encode brain health information that may identify individuals at high risk for age-related brain diseases.

6. stgeorgeutah.com stgeorgeutah.com/news/can-brain-boosting-supplements-give-america-a-cognitive-edge/article_0ec63027-bd03-43ca-927e-f94a8f82a368.html

Can brain-boosting supplements give America a cognitive ... However, America is grappling with serious cognitive health concerns. According to data from the Centers for Disease Control and Prevention and ...

7. health.harvard.edu health.harvard.edu/blog/court-ruling-curbs-unfounded-claims-for-memory-supplement-201905311887

Court ruling curbs unfounded claims for memory supplement The makers of Prevagen are prohibited from claiming that the supplement can improve brain function or memory.

8. nextmsc.com nextmsc.com/blogs/brain-health-supplements-evidence-benefits-risks

Brain Health Supplements: Evidence, Benefits & Risks Lack of long-term safety data is common for newer compounds. Regulatory oversight is weaker for supplements; quality issues are possible ...

9. nih.gov nih.gov/news-events/nih-research-matters/healthful-diet-linked-reduced-risk-cognitive-decline

Healthful diet linked to reduced risk of cognitive decline A heart-healthy eating pattern called the MIND diet was associated with a lower risk of cognitive decline or impairment.