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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.
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.
For subjects of childbearing potential, a urine pregnancy test (UPT) will be administered to ensure the subject is not pregnant.
Subjects will fill out the Entry Survey on a computer tablet.
Subjects will participate in the PEBL testing battery on a laptop using a keyboard and mouse. The battery includes the following tests:
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.
Subjects will use the VR headset to play 3 songs in Beat Saber.
Subjects will fill out the Visit 1 Mid-Visit Snapshot Survey on a computer tablet.
Next, subjects will again participate in the PEBL testing battery using a mouse and keyboard. The tests will be the same as before.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental | Dietary Supplement | Brain Edge, a cognition supporting supplement beverage formulated from herbs, vitamins, and amino acids. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Attention Shifting | Assessed by changes in attention shifting score in the Berg-Wisconsin Card Sorting Task Test. | Prior to supplementation (Baseline) and 30 minutes after supplementation (Post) during each of the 3 clinical visits. |
| Working Memory |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Lamb, MD | Nature's Sunshine Products, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hughes Center for Research and Innovation | Lehi | Utah | 84043 | United States |
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| ID | Term |
|---|---|
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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Double Blind Placebo Controlled
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| Placebo | Other | A sensory-matched placebo beverage formulated from flavors, colors, fillers, and excipients. |
|
| Water | Other | Bottled Water |
|
Assessed by changes in score in Sternberg Scanning Task Test.
| Prior to supplementation (Baseline) and 30 minutes after supplementation (Post) during each of the 3 clinical visits. |
| Reaction Time | Assessed by changes in score in 9-cell reaction test. | Prior to supplementation (Baseline) and 30 minutes after supplementation (Post) during each of the 3 clinical visits. |
| Selective Attention | Assessed by changes in score in Stroop Task Test. | Prior to supplementation (Baseline) and 30 minutes after supplementation (Post) during each of the 3 clinical visits. |
| Executive Function | Assessed by a change in scores in a simple mathematics test | Prior to supplementation (Baseline) and 30 minutes after supplementation (Post) during each of the 3 clinical visits. |
| Visual Processing | Assessed by score in Matrix Rotation Test | Prior to supplementation (Baseline) and 30 minutes after supplementation (Post) during each of the 3 clinical visits. |
| Gaming Performance | Assessed by score changes in Beat Saber (Virtual Reality Rhythm game). | Prior to supplementation (Baseline) and 60 minutes after supplementation (Post) during each of the 3 clinical visits. |
| Subjective Mood and Emotional State | Assessed by relative changes in scored survey question results. | Prior to Supplementation (Baseline), 30 minutes after supplementation (Midpoint) and approximately 90 minutes after supplementation (Post) on each of the 3 clinical visits. |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |