Acute Cognitive Effects of Brain Edge

NCT07018674 | Completed

• 1 other identifier: NSP-CT-023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognitive Health; Mood

Outcome Measures

Primary Outcomes (1)

• Number of participants with supplementation-related adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0).

  Data collected at individual study visits will be used to assess participants for any adverse events associated with the study procedures or products. Subjects with ongoing adverse events will be followed until resolution at the discretion of the PI.

  7 days after final clinical visit

Secondary Outcomes (8)

• Attention Shifting

  Prior to supplementation (Baseline) and 30 minutes after supplementation (Post) during each of the 3 clinical visits.

• Working Memory

  Prior to supplementation (Baseline) and 30 minutes after supplementation (Post) during each of the 3 clinical visits.

• Reaction Time

  Prior to supplementation (Baseline) and 30 minutes after supplementation (Post) during each of the 3 clinical visits.

• Selective Attention

  Prior to supplementation (Baseline) and 30 minutes after supplementation (Post) during each of the 3 clinical visits.

• Executive Function

  Prior to supplementation (Baseline) and 30 minutes after supplementation (Post) during each of the 3 clinical visits.

Study Arms (2)

Crossover Arm 1: Brain Edge then Placebo

EXPERIMENTAL

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

Dietary Supplement: Experimental; Other: Placebo; Other: Water

Crossover Arm 2: Placebo then Brain Edge

EXPERIMENTAL

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

Dietary Supplement: Experimental; Other: Placebo; Other: Water

Interventions

Experimental DIETARY_SUPPLEMENT

Brain Edge, a cognition supporting supplement beverage formulated from herbs, vitamins, and amino acids.

Crossover Arm 1: Brain Edge then Placebo; Crossover Arm 2: Placebo then Brain Edge

Placebo OTHER

A sensory-matched placebo beverage formulated from flavors, colors, fillers, and excipients.

Crossover Arm 1: Brain Edge then Placebo; Crossover Arm 2: Placebo then Brain Edge

Water OTHER

Bottled Water

Crossover Arm 1: Brain Edge then Placebo; Crossover Arm 2: Placebo then Brain Edge

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men, women and non-binary adults, ≥18 and \<60 years old
• Generally healthy
• Ability to understand and the willingness to follow the study procedures.
• Willing to maintain a consistent diet (including medications, vitamins and supplements) and lifestyle routine throughout the study.
• Willing to give written informed consent to participate in the study.

You may not qualify if:

• Pregnant or nursing.
• Minors below the age of majority.
• Taking any prescription stimulants or anxiolytics.
• Typical caffeine intake above 250 mg/day.
• Neurological conditions including epilepsy, color blindness, ADD / ADHD, Learning disabilities, or dementia.
• Change in prescription, non-prescription, nutritional supplements and/or medical foods within 7 days prior to Day 1 and for the duration of the study.
• Use of prescriptions medications and/or nonprescription medications for acute and semi-acute medical conditions 30 days prior to Day 1 and for the duration of the study.
• Use of an investigational drug or participation in an investigational study within 30 days prior to Day 1 and for the duration of the study.
• Routine use of high dose caffeine \>250mg products within 7 days prior to Day 1 and for the duration of the study.
• Subjects with a history of allergy or intolerance to any ingredient in study product. Specific details of each product will be included in the formal Study Informed Consent.
• Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, immunologic, or hematologic disease.
• Subjects with a current diagnosis or personal history of:
• Any cardiovascular disease including myocardial infarction, angina, cardiovascular surgery, congestive heart failure, cardiac arrhythmias or conduction abnormalities, cerebrovascular accident, transient ischemic attack (TIA), or peripheral vascular disease, deep vein thrombosis or pulmonary embolus.
• Any neurological condition including ADD, ADHD, Epilepsy, Narcolepsy, insomnia, or autism spectrum disorders.
• Any serious mental illness including a history of attempted suicide.

Sponsors & Collaborators

• Nature's Sunshine Products, Inc.: lead

Study Sites (1)

The Hughes Center for Research and Innovation

Lehi, Utah, 84043, United States

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Joseph Lamb, MD

  Nature's Sunshine Products, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double Blind Placebo Controlled

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 12, 2025
• Study Start: August 20, 2025
• Primary Completion: November 16, 2025
• Study Completion: November 20, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)