Acute Cognitive Effects of Brain Edge

Launched by NATURE'S SUNSHINE PRODUCTS, INC. · Jun 10, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of a supplement called Brain Edge, which contains a mix of herbs and amino acids, on cognitive health and mood. The study will involve 50 healthy adults who are between 18 and 60 years old. It will be conducted in three sessions, where participants will undergo tests to assess their thinking and memory skills using computer programs, surveys, and virtual reality experiences. This is a double-blind study, meaning that neither the participants nor the researchers will know who is receiving the actual supplement and who is getting a placebo (a dummy treatment), to ensure unbiased results.

To be eligible for this trial, participants must be generally healthy, able to follow study guidelines, and willing to stick to a consistent diet and lifestyle during the study. Some people won't be able to participate, including those who are pregnant, have certain health conditions (like neurological issues or serious illnesses), or take specific medications. If you decide to join, you'll be asked to give your consent and will be closely monitored throughout the study to ensure your safety and comfort. This research aims to provide more information on how Brain Edge might affect cognitive abilities and mood.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.
• • Use of drugs of abuse (such as marijuana, cocaine, opiates and methamphetamine) 7 days prior to Day 1 and for the duration of the study.
• • Inability to comply with study and/or follow-up visits.
• • Any concurrent condition (including clinically significant abnormalities in medical history, physical examination, or laboratory evaluations) which, in the opinion of the PI, would preclude safe participation in this study or interfere with compliance.
• • Any sound medical, psychiatric and/or social reason which, in the opinion of the PI, would preclude safe participation in this Study or interfere with compliance.
• • Co-enrollment in other trials is restricted other than for observational studies. Study staff should be notified of co-enrollment as it may require the approval of the investigator.