Cognitive HealthNCT07018674
Acute Cognitive Effects of Brain Edge
A study testing Experimental and Water in people with Cognitive Health and Mood, run by Nature's Sunshine Products, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Health, Mood
- What is being tested?
- Experimental and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2025to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Hughes Center for Research and Innovation
Lehi, Utah, 84043
About this study
Official title: Evaluation of Acute Cognitive Effects of Brain Edge on Healthy Volunteers
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.
Read the 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.
- 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:
- Matrix Pattern Rotation
- Stroop Task
- Sternberg Scanning Task
- Berg Wisconsin Card Sorting
- 9-Cell reaction test
- Math Test
- 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.
- Rum N Bass
- Burning Sands
- A song designated by study staff.
- 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.
- Conditions
- Cognitive Health, Mood
- Being tested
- Experimental, Placebo, Water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalDietary supplement
Brain Edge, a cognition supporting supplement beverage formulated from herbs, vitamins, and amino acids.
PlaceboOther
A sensory-matched placebo beverage formulated from flavors, colors, fillers, and excipients.
WaterOther
Bottled Water
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Experimental; Other: Placebo; Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days after final clinical visit
Secondary outcomes (8)
Attention Shifting
Assessed by changes in attention shifting score in the Berg-Wisconsin Card Sorting Task Test.
Measured: Prior to supplementation (Baseline) and 30 minutes after supplementation (Post) during each of the 3 clinical visits.
Working Memory
Assessed by changes in score in Sternberg Scanning Task Test.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: Prior to Supplementation (Baseline), 30 minutes after supplementation (Midpoint) and approximately 90 minutes after supplementation (Post) on each of the 3 clinical visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start20 Aug 2025
- Primary completion16 Nov 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double Blind Placebo Controlled
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nature's Sunshine Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Lamb, MD, Principal investigator, Nature's Sunshine Products, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018674
- Sponsor's protocol ID
- NSP-CT-023
- Status last verified
- Apr 2026
- First submitted
- 14 May 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Acute Cognitive Effects of Brain Edge on Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07018674
- Acronym / sponsor ID
- NSP-CT-023
- Conditions
- Cognitive Health, Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nature's Sunshine Products, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 16 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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:
- Matrix Pattern Rotation
- Stroop Task
- Sternberg Scanning Task
- Berg Wisconsin Card Sorting
- 9-Cell reaction test
- Math Test
- 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.
- Rum N Bass
- Burning Sands
- A song designated by study staff.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Double Blind Placebo Controlled
| Arm | Type | Receives |
|---|---|---|
| Crossover Arm 1: Brain Edge then Placebo | Experimental | Dietary Supplement: Experimental, Other: Placebo, Other: WaterParticipants 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 | Dietary Supplement: Experimental, Other: Placebo, Other: WaterParticipants will receive Water during visit 1, the Placebo during Visit 2, and Brain Edge during Visit 3 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalBrain Edge, a cognition supporting supplement beverage formulated from herbs, vitamins, and amino acids. | Dietary supplement | Crossover Arm 1: Brain Edge then Placebo, Crossover Arm 2: Placebo then Brain Edge |
| PlaceboA sensory-matched placebo beverage formulated from flavors, colors, fillers, and excipients. | Other | Crossover Arm 1: Brain Edge then Placebo, Crossover Arm 2: Placebo then Brain Edge |
| WaterBottled Water | Other | Crossover Arm 1: Brain Edge then Placebo, Crossover Arm 2: Placebo then Brain Edge |
Primary outcome
Number of participants with supplementation-related adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0).
Time frame: 7 days after final clinical visit
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.
8 secondary outcomes
Attention Shifting
Time frame: Prior to supplementation (Baseline) and 30 minutes after supplementation (Post) during each of the 3 clinical visits.
Working Memory
Time frame: Prior to supplementation (Baseline) and 30 minutes after supplementation (Post) during each of the 3 clinical visits.
Reaction Time
Time frame: Prior to supplementation (Baseline) and 30 minutes after supplementation (Post) during each of the 3 clinical visits.
Selective Attention
Time frame: Prior to supplementation (Baseline) and 30 minutes after supplementation (Post) during each of the 3 clinical visits.
Executive Function
Time frame: Prior to supplementation (Baseline) and 30 minutes after supplementation (Post) during each of the 3 clinical visits.
Visual Processing
Time frame: Prior to supplementation (Baseline) and 30 minutes after supplementation (Post) during each of the 3 clinical visits.
Gaming Performance
Time frame: Prior to supplementation (Baseline) and 60 minutes after supplementation (Post) during each of the 3 clinical visits.
Subjective Mood and Emotional State
Time frame: Prior to Supplementation (Baseline), 30 minutes after supplementation (Midpoint) and approximately 90 minutes after supplementation (Post) on each of the 3 clinical visits.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Lamb, MD principal investigator
Nature's Sunshine Products, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental and Water in people with Cognitive Health and Mood, run by Nature's Sunshine Products, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with supplementation-related adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0). (time frame: 7 days after final clinical visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.