Attention DifficultiesNCT05530915
Guayusa: The Effect of an Herbal Extract on Alertness and Mental Fatigue
A study testing Gel capsule in people with Attention Difficulties, run by PepsiCo Global R&D at 1 site in United States.
Trial summary
The primary objective of this randomized, double-blind, placebo-controlled, cross-over study is to assess the acute effects of a novel ingredient, guayusa on alertness and mental fatigue compared to a placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Difficulties
- What is being tested?
- Gel capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2022to 7 Nov 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, 18-55 years of age, inclusive at Visit 1 (Day -7).
- BMI <30 kg/m2 at Visit 1 (Day -7).
- Self-reported poor attention during pre-screening phone call prior to Visit 1 (Day -7).
- Willing to abstain from alcohol and vigorous physical activity 24 h prior to Visits 1, 2, 3, and 4 (Days -7, 0, 7, and 14).
- Willing to abstain from all exercise the morning of Visits 1, 2, 3, and 4 (Days -7, 0, 7, and 14).
- Willing and able to comfortably abstain from caffeine for 24 h prior to Visits 1, 2, 3, and 4 (Days -7, 0, 7, and 14).
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- Non-user of nicotine products (e.g., cigarettes, patches/gum, etc.) within 60 days of Visit 1 (Day-7).
- Non-user of marijuana and hemp products including CBD products within 60 days of Visit 1 (Day-7).
- Willing to abstain from over-the-counter drugs or supplements that have stimulating (e.g., containing caffeine or guayusa), cognition boosting, or sedating (e.g., sleeping aids, anti-histamines, decongestants) effects (Appendix 1) for 24 h prior to and during all visits.
- Willing to maintain habitual diet (including fluids, caffeine, and alcohol), physical activity patterns, sleeping patterns (3 days before each test visit), and body weight throughout the trial.
- Willing to maintain habitual intake of approved vitamins and supplements throughout the study except during Visits 2, 3, and 4 (Days 0, 7, and 14) whereby participants are required to abstain from any supplements until the end of the study visits.
- Has no health conditions that would prevent him or her from fulfilling the study requirements or affect study outcomes as judged by the Principal Investigator on the basis of medical history and routine laboratory test results.
- Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Principal Investigator.
Who cannot join
- Unable to understand and/or completely perform the practice test to standard minimum requirements and based on queries performed following the practice test at Visit 1 (Day -7).
- Visual impairments that cannot be corrected with glasses or contact lenses.
- Known intolerance, allergy, or sensitivity to caffeine or any of the other ingredients in the study products and/or any ingredients of the standardized snack provided, including shellfish, egg, fish, gluten, milk, peanuts, soy, tree nuts (coconut and walnut), and gelatin.
- Extreme dietary habits (e.g., intermittent fasting, low carbohydrate diet) that would affect study outcomes as judged by the Principal Investigator.
- Unstable dose of prescription medications (stable is defined as same dose for the past 90 d prior to Visit 1; Day -7).
- Use of prescription drugs (stable or unstable) that have stimulating (e.g., amphetamines [Adderall® and Dexedrine®], methylphenidate [Concerta® and Ritalin®], diet aids [such as Didrex®, Bontril®, Preludin®, Fastin®, Adipex P®, Ionomin®, and Meridia®], containing caffeine or guayusa), cognition boosting, or sedating (e.g., sleeping aids, drugs to treat mental health disorders) effects.
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- For females on hormone therapy (including oral contraceptives), the subject must be on a stable dose of hormones (defined as same dose for the past 90 d prior to Visit 1; Day -7).
- Signs or symptoms of an active infection of clinical relevance (e.g., urinary tract or respiratory) within 5 d prior to Visits 2, 3, and 4 (Days 0, 7, and 14). If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved (at the discretion of the Principal Investigator) at least 5 d prior to testing, unless the visit will be out of window. If the visit will be out of window, subjects should continue with testing and a protocol deviation will be required.
- Experienced evidence of delirium, confusion, or other disturbances of consciousness to the degree that could affect study outcomes, in the judgement of the Principal Investigator.
- History of learning and/or behavioral disorders such as dyslexia or diagnosed attention deficit hyperactive disorder (ADHD).
- Neurologic disorder that could produce cognitive deterioration including, but not limited to, Alzheimer's disease, Parkinson's disease, stroke, intracranial hemorrhage, local brain lesions including tumors, and normal pressure hydrocephalus.
- History of any infective or inflammatory brain disease, including those of viral, fungal, or syphilitic etiologies.
- History of frequent (≥ 1 occasion/month) migraines that require medication.
- History of repeated minor head injury (e.g., in boxing) or a single injury resulting in a period of unconsciousness for 1 h or more.
- History or presence of clinically uncontrolled important endocrine (including hyperparathyroidism, type 1 or 2 diabetes mellitus and/or hypoglycemia), cardiovascular (including, but not limited to history of myocardial infarction, peripheral arterial disease,), pulmonary (including uncontrolled asthma), hepatic, renal, gastrointestinal, hematologic, immunologic, dermatologic, rheumatic (including gout), and/or biliary, that, in the opinion of the Principal Investigator, could interfere with the interpretation of the study results.
- History or presence of cancer in the prior two years, except for non-melanoma skin cancer.
- History of major physical trauma (e.g., required hospitalization) or mental trauma (e.g., abuse) within 6 months of Visit 1 (Day -7).
- Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the blood pressure measured at Visit 1 (Day -7). One re-test will be allowed on a separate day prior to Visit 2 (Day 0), for subjects with abnormal blood pressure.
- Heavy consumer of caffeinated beverages (>400 mg caffeine/d from caffeine-containing products; Appendix 2).
- Sleep disorder (e.g., sleep apnea) or occupation where sleep during the overnight hours is irregular (e.g., 3rd shift of overnight workers).
- Female who is pregnant, planning to be pregnant during the study period, or lactating,
- Female of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
- Exposure to any non-registered drug product or has participated in another intervention study within 30 d prior to Visit 1 (Day -7).
- Recent history of (within 12 months of screening; Visit 1; Day -7) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Has a condition the Principal Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Innovation Services, Division of Merieux NutriSciences
Addison, Illinois, 60101
About this study
The primary objective of this randomized, double-blind, placebo-controlled, cross-over study is to assess the acute effects of a novel ingredient, guayusa on alertness and mental fatigue compared to a placebo. This trial will utilize the COMPASS cognitive task and cognitive demand battery (CDB) and mood, motivation, and energy measures with assessments taking place at baseline, 60- and 120-minutes post treatment on three separate testing days separated by ~7 days.
- Conditions
- Attention Difficulties
- Being tested
- Gel capsule
- Keywords
- mental fatigue, alertness, cognitive, COMPASS, guayusa, energy, fatigue, mood, memory
- Medical subject headings
- Mental Fatigue, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gel capsuleOther
Single capsule per dose
| Study group | Role | What they receive |
|---|---|---|
| Active capsule 1: Lower dose guayusa ingredient | Experimental | Oral administration of 175 mg guayusa extract providing 35 mg caffeine Receives: Other: Gel capsule |
| Active capsule 2: Higher dose guayusa ingredient | Experimental | Oral administration of 300 mg guayusa extract providing 60 mg caffeine Receives: Other: Gel capsule |
| Placebo capsule | Placebo comparator | Oral administration of 0 mg guayusa extract, 0 mg caffeine. Capsule color-matched to actives 1 and 2 to disguise potential differences in color of contents. Receives: Other: Gel capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental alertness
Current subjective alertness rating on a Visual Analog Scale (VAS) in the COMPASS Cognitive Demand Battery (CDB) by marking on a 100-mm line with the end points labelled "not at all" (left hand end) and "extremely" (right hand end). Scores are calculated as percentage along the line from left to right. Increased alertness is better.
Measured: Change from pre-dose baseline to 60 minutes post-guayusa consumption compared to placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start27 Jul 2022
- Primary completion7 Nov 2022
- Study completion7 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention DifficultiesStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dawn Beckman, MD, Principal investigator, Mérieux NutriSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530915
- Sponsor's protocol ID
- PEP-2113
- Status last verified
- Nov 2022
- First submitted
- 2 Sep 2022
- Last updated
- 14 Nov 2022
- 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 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guayusa: The Effect of an Herbal Extract on Alertness and Mental Fatigue
- ClinicalTrials.gov ID
- NCT05530915
- Acronym / sponsor ID
- PEP-2113
- Conditions
- Attention Difficulties
- Keywords
- mental fatigue, alertness, cognitive, COMPASS, guayusa, energy, fatigue, mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 7 Sep 2022 (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.
The primary objective of this randomized, double-blind, placebo-controlled, cross-over study is to assess the acute effects of a novel ingredient, guayusa on alertness and mental fatigue compared to a placebo. This trial will utilize the COMPASS cognitive task and cognitive demand battery (CDB) and mood, motivation, and energy measures with assessments taking place at baseline, 60- and 120-minutes post treatment on three separate testing days separated by ~7 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active capsule 1: Lower dose guayusa ingredient | Experimental | Other: Gel capsuleOral administration of 175 mg guayusa extract providing 35 mg caffeine |
| Active capsule 2: Higher dose guayusa ingredient | Experimental | Other: Gel capsuleOral administration of 300 mg guayusa extract providing 60 mg caffeine |
| Placebo capsule | Placebo comparator | Other: Gel capsuleOral administration of 0 mg guayusa extract, 0 mg caffeine. Capsule color-matched to actives 1 and 2 to disguise potential differences in color of contents. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Male or female, 18-55 years of age, inclusive at Visit 1 (Day -7).
- BMI <30 kg/m2 at Visit 1 (Day -7).
- Self-reported poor attention during pre-screening phone call prior to Visit 1 (Day -7).
- Willing to abstain from alcohol and vigorous physical activity 24 h prior to Visits 1, 2, 3, and 4 (Days -7, 0, 7, and 14).
- Willing to abstain from all exercise the morning of Visits 1, 2, 3, and 4 (Days -7, 0, 7, and 14).
Key exclusion criteria (25 listed)
- Unable to understand and/or completely perform the practice test to standard minimum requirements and based on queries performed following the practice test at Visit 1 (Day -7).
- Visual impairments that cannot be corrected with glasses or contact lenses.
- Known intolerance, allergy, or sensitivity to caffeine or any of the other ingredients in the study products and/or any ingredients of the standardized snack provided, including shellfish, egg, fish, gluten, milk, peanuts, soy, tree nuts (coconut and walnut), and gelatin.
- Extreme dietary habits (e.g., intermittent fasting, low carbohydrate diet) that would affect study outcomes as judged by the Principal Investigator.
- Unstable dose of prescription medications (stable is defined as same dose for the past 90 d prior to Visit 1; Day -7).
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 |
|---|---|---|
| Gel capsuleSingle capsule per dose | Other | Active capsule 1: Lower dose guayusa ingredient, Active capsule 2: Higher dose guayusa ingredient, Placebo capsule |
Primary outcome
Mental alertness
Time frame: Change from pre-dose baseline to 60 minutes post-guayusa consumption compared to placebo
Current subjective alertness rating on a Visual Analog Scale (VAS) in the COMPASS Cognitive Demand Battery (CDB) by marking on a 100-mm line with the end points labelled "not at all" (left hand end) and "extremely" (right hand end). Scores are calculated as percentage along the line from left to right. Increased alertness is better.
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 14 Nov 2022.
- 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.
Dawn Beckman, MD principal investigator
Mérieux NutriSciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gel capsule in people with Attention Difficulties, run by PepsiCo Global R&D 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 13 inclusion and 25 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 14 Nov 2022. 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. Some participants in this study may receive a placebo. 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?
Mental alertness (time frame: Change from pre-dose baseline to 60 minutes post-guayusa consumption compared to placebo). 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 14 Nov 2022.