Active capsule 1: Lower dose guayusa ingredient for Attention Difficulties

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Biofortis Innovation Services, Division of Merieux NutriSciences, Addison, IL
Attention Difficulties+2 More
Gel capsule - Other
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Attention Difficulties

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Attention Difficulties

Study Objectives

0 Primary · 0 Secondary · Reporting Duration: Change from pre-dose baseline to 60 minutes and 120 minutes post-guayusa consumption compared to placebo

Change from pre-dose baseline to 120 minutes post-guayusa consumption compared to placebo.
Mental alertness
Change from pre-dose baseline to 60 minutes and 120 minutes post-guayusa consumption compared to placebo
Cognitive memory test: Pictures
Cognitive memory test: Words
Cognitive test RVIP
Cognitive test Serial Subtraction
Energy & Fatigue State (EFS) Scales
Mental fatigue
Mood

Trial Safety

Safety Progress

1 of 3

Other trials for Attention Difficulties

Trial Design

3 Treatment Groups

Active capsule 1: Lower dose guayusa ingredient
1 of 3
Active capsule 2: Higher dose guayusa ingredient
1 of 3
Placebo capsule
1 of 3
Experimental Treatment
Non-Treatment Group

60 Total Participants · 3 Treatment Groups

Primary Treatment: Active capsule 1: Lower dose guayusa ingredient · Has Placebo Group · N/A

Active capsule 1: Lower dose guayusa ingredient
Other
Experimental Group · 1 Intervention: Gel capsule · Intervention Types: Other
Active capsule 2: Higher dose guayusa ingredient
Other
Experimental Group · 1 Intervention: Gel capsule · Intervention Types: Other
Placebo capsule
Other
PlaceboComparator Group · 1 Intervention: Gel capsule · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from pre-dose baseline to 60 minutes and 120 minutes post-guayusa consumption compared to placebo
Closest Location: Biofortis Innovation Services, Division of Merieux NutriSciences · Addison, IL
N/AFirst Recorded Clinical Trial
1 TrialsResearching Attention Difficulties
0 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a BMI of <30 kg/m2 at Visit 1 (Day -7).
You have poor attention during pre-screening phone call prior to Visit 1 (Day -7).
You are 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).
You are willing and able to abstain from caffeine for 24 h prior to Visits 1, 2, 3, and 4 (Days -7, 0, 7, and 14).
You are not currently using nicotine products (e.g., cigarettes, patches/gum, etc.
You are not a current or former user of marijuana or hemp products including CBD products.
You are willing to abstain from over-the-counter drugs or supplements that have stimulating (e.g., caffeine or guayusa), cognition boosting, or sedating (e.g.
You are willing to maintain your habitual diet, physical activity patterns, sleeping patterns, and body weight throughout the trial.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.