NCT07018674

Acute Cognitive Effects of Brain Edge

Evaluation of Acute Cognitive Effects of Brain Edge on Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Nature's Sunshine Products, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

A double-blind placebo-controlled crossover study exploring the cognitive effects of Brain Edge; a supplement consisting of a blend of herbs and amino acids. 50 healthy adult subjects will be evaluated over 3 sessions. Evaluation of cognitive performance will be determined by computer-based software, surveys, and VR headset experiences.

Detailed description

Clinical visits will take place in the mornings over 3 days. Subjects will meet with principal investigator or study staff at all clinical visits. During the clinical visits, the study clinician will assess for signs and symptoms of adverse events, dispense study products, administer the cognitive tests, and answer any questions from the subjects. Visit 1 is characterized by subject screening, familiarizing participants with the cognitive tests, and establishing baseline performance values. After Subject Consent has been obtained, subjects will be assigned a Subject Identification Number (ID) and be randomly assigned to a study arm. 1. For subjects of childbearing potential, a urine pregnancy test (UPT) will be administered to ensure the subject is not pregnant. 2. Subjects will fill out the Entry Survey on a computer tablet. 3. Subjects will participate in the PEBL testing battery on a laptop using a keyboard and mouse. The battery includes the following tests: 1. Matrix Pattern Rotation 2. Stroop Task 3. Sternberg Scanning Task 4. Berg Wisconsin Card Sorting 5. 9-Cell reaction test 6. Math Test 4. Subject will be offered some water to drink. On visit 2 and 3, study staff will provide subject with a prepared sample of either Brain Edge, or Placebo. Samples will be administered in a double blinded manner. 5. Subjects will use the VR headset to play 3 songs in Beat Saber. 1. Rum N Bass 2. Burning Sands 3. A song designated by study staff. 6. Subjects will fill out the Visit 1 Mid-Visit Snapshot Survey on a computer tablet. 7. Next, subjects will again participate in the PEBL testing battery using a mouse and keyboard. The tests will be the same as before. 8. The participant will again use the VR headset to play some songs. 2 of the songs will be the same as previous (Rum N Bass and Burning Sands), while the third song will be different. 9. Each participant will then be given the Visit Exit survey to fill out. Principal investigator or study staff will be available to provide explanations for the tests, answer any questions about the study or product, and to provide technical support for any of the devices. The test results from this day will provide a set of baseline values that will be used as a reference point for the tests on subsequent days. Visit 2 marks the beginning of the experimental crossover portion of the study. Principal investigator or Study staff will answer questions and resolve subjects' concerns as needed. Subjects will repeat the same testing procedures as the previous visit, with the addition of taking either the placebo or the Brain Edge sample immediately before playing the first round of Beat Saber. Samples will be double blinded. Visit 3 will be the crossover portion of the study. If participants received a placebo during visit 2, the study sample for visit 3 will be Brain Edge. Conversely, those who received Brain Edge during visit 2 will receive a placebo during visit 3. Study testing procedures will proceed in the same manner as previous visits. Visit 3 is the final visit of the study. However, to ensure that all adverse events are captured and recorded, subjects will be asked to fill out a final survey on the day following their last visit.

Conditions

• Cognitive Health
• Mood

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Experimental	Brain Edge, a cognition supporting supplement beverage formulated from herbs, vitamins, and amino acids.
OTHER	Placebo	A sensory-matched placebo beverage formulated from flavors, colors, fillers, and excipients.
OTHER	Water	Bottled Water

Timeline

• Start date: 2025-08-20
• Primary completion: 2025-11-16
• Completion: 2025-11-20
• First posted: 2025-06-12
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States