Guayusa: The Effect of an Herbal Extract on Alertness and Mental Fatigue

NCT05530915 | Completed

• 1 other identifier: PEP-2113
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

mental fatigue; alertness; cognitive; COMPASS; guayusa; energy; fatigue; mood; memory

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from pre-dose baseline to 60 minutes post-guayusa consumption compared to placebo

Other Outcomes (8)

• Mental alertness

  Change from pre-dose baseline to 120 minutes post-guayusa consumption compared to placebo.

• Mental fatigue

  Change from pre-dose baseline to 60 minutes and 120 minutes post-guayusa consumption compared to placebo

• Energy & Fatigue State (EFS) Scales

  Change from pre-dose baseline to 60 minutes and 120 minutes post-guayusa consumption compared to placebo

Study Arms (3)

Active capsule 1: Lower dose guayusa ingredient

EXPERIMENTAL

Oral administration of 175 mg guayusa extract providing 35 mg caffeine

Other: Gel capsule

Active capsule 2: Higher dose guayusa ingredient

EXPERIMENTAL

Oral administration of 300 mg guayusa extract providing 60 mg caffeine

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.

Other: Gel capsule

Interventions

Gel capsule OTHER

Single capsule per dose

Active capsule 1: Lower dose guayusa ingredient; Active capsule 2: Higher dose guayusa ingredient; Placebo capsule

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

Biofortis Innovation Services, Division of Merieux NutriSciences

Addison, Illinois, 60101, United States

Location

MeSH Terms

Conditions

Mental Fatigue; Fatigue

Interventions

Gels

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Dawn Beckman, MD

  Mérieux NutriSciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: July 27, 2022
• Primary Completion: November 7, 2022
• Study Completion: November 7, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)