Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2025-07-31
2025-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Crossover Arm 1: Brain Edge then Placebo
Participants will receive Water during Visit 1, Brain Edge during Visit 2, and the Placebo on Visit 3
Experimental
Brain Edge, a cognition supporting supplement beverage formulated from herbs, vitamins, and amino acids.
Placebo
A sensory-matched placebo beverage formulated from flavors, colors, fillers, and excipients.
Water
Bottled Water
Crossover Arm 2: Placebo then Brain Edge
Participants will receive Water during visit 1, the Placebo during Visit 2, and Brain Edge during Visit 3
Experimental
Brain Edge, a cognition supporting supplement beverage formulated from herbs, vitamins, and amino acids.
Placebo
A sensory-matched placebo beverage formulated from flavors, colors, fillers, and excipients.
Water
Bottled Water
Interventions
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Experimental
Brain Edge, a cognition supporting supplement beverage formulated from herbs, vitamins, and amino acids.
Placebo
A sensory-matched placebo beverage formulated from flavors, colors, fillers, and excipients.
Water
Bottled Water
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
64 Years
ALL
Yes
Sponsors
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Nature's Sunshine Products, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joseph Lamb, MD
Role: PRINCIPAL_INVESTIGATOR
Nature's Sunshine Products, Inc.
Locations
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The Hughes Center for Research and Innovation
Lehi, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NSP-CT-023
Identifier Type: -
Identifier Source: org_study_id
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