- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06062186
Acute Effects of Naturally Occurring Tea and Coffee-based Ingredients on Cognitive Performance
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a double-blind, randomized, three-arm, single-dose, placebo-controlled crossover trial of forty (40) apparently healthy male and female participants. The objective of this study is to assess the effects of AmaTea Max Organic Guayusa Extract and Lion's Mane on cognitive responses including mental clarity, mood, focus, concentration, productivity, anxiety/stress, happiness, and accuracy. Since these dietary supplements are on the market for consumer use, it is important to investigate and confirm their potential benefits, comparisons, and safety through further research.
Subjects will attend 4 study visits. During Visit 1, subjects will be screened for participation (i.e., medical history, routine blood work, background baseline diet). During Visits 2, 3 and 4, at 3 time points (pre-ingestion, 60 and 120 minutes post ingestion), participants will complete subjective baseline testing including questionnaires that assess mental clarity, mood, focus, concentration, productivity, anxiety/stress, and the Happiness Scale in addition to completing a series of objective neuropsychological tests (e.g., Go/no-go test, N-back test, Serial Sevens test) to assess cognitive performance. Safety will be monitored via vital signs (heart rate, blood pressure) and adverse events (AE) throughout study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Canfield, Ohio, United States, 44406
- The Center for Applied Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Provide voluntary signed and dated informed consent.
- Be in good health and able to participate in cognitive performance testing as determined by assessment, medical history and routine blood chemistries.
- Between the of 18 and 50 years of age (inclusive).
- Body Mass Index of 18.5-39.9 (inclusive).
- Body weight of at least 110 pounds.
- Normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
- Normal supine, resting heart rate (<90 per minute).
- Able to provide an adequate blood draw.
- Habitually consumes ≤ 240 mg caffeine/day (equivalent of 3 cups of coffee). Dietary supplementation consistent over one month and able to maintain supplementation throughout study.
- If dietary supplement initiated within the past month, participant is willing to discontinue supplement use followed by a 2-week washout prior to participation in the study.
- Willing to duplicate their previous 24-hour diet, refrain from caffeine for 12 hours, refrain from exercise for 24 hours prior to each trial, and fast for 8 hours prior each of the treatments.
Exclusion Criteria:
- Current smoker or other nicotine use (i.e. vape, patch, etc.).
- History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
- Prior gastrointestinal bypass surgery (Lapband, etc.).
- Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g. electrolyte abnormalities, diabetes, thyroid disease, adrenal disease, hypogonadism, short bowel syndrome, diarrheal illnesses, history of colon resection, gastric ulcer, reflux disease, gastroparesis, Inborn-Errors-of-Metabolism (such as PKU).
- Chronic inflammatory condition or disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.).
- History of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
- History of cognitive disorder.
- History of psychiatric disorder.
- Known sensitivity to any ingredient in the test formulations as listed in the Certificates-of-Analysis.
- Women currently pregnant, trying to become pregnant or breastfeeding a child.
- Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoint or place the subject at increased risk of harm if they were to participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
650 mg of placebo, given as two capsules containing maltodextrin
|
650 mg of placebo, given as two capsules containing maltodextrin
|
Experimental: AmaTea Max Guayusa extract
650 mg of AmaTea Guayusa Extract, given as two capsules
|
650 mg of AmaTea Guayusa Extract, given as two capsules
|
Experimental: Lion's Mane
1000 mg of Lion's Mane, given as two capsules
|
1000 mg of Lion's Mane, given as two capsules
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration
Time Frame: Change from baseline to 60 minutes and 120 minutes.
|
Concentration as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better concentration.
|
Change from baseline to 60 minutes and 120 minutes.
|
Mental Clarity
Time Frame: Change from baseline to 60 minutes and 120 minutes.
|
Mental clarity as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better mental clarity.
|
Change from baseline to 60 minutes and 120 minutes.
|
Mood
Time Frame: Change from baseline to 60 minutes and 120 minutes.
|
Mood as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better mood.
|
Change from baseline to 60 minutes and 120 minutes.
|
Focus
Time Frame: Change from baseline to 60 minutes and 120 minutes.
|
Focus as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better focus.
|
Change from baseline to 60 minutes and 120 minutes.
|
Productivity
Time Frame: Change from baseline to 60 minutes and 120 minutes.
|
Productivity as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better productivity.
|
Change from baseline to 60 minutes and 120 minutes.
|
Stress
Time Frame: Change from baseline to 60 minutes and 120 minutes.
|
Stress as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater stress.
|
Change from baseline to 60 minutes and 120 minutes.
|
Happiness
Time Frame: Change from baseline to 60 minutes and 120 minutes.
|
Happiness as measured by The Subjective Happiness Scale, where values can range from 4 to 28, and higher values represent greater happiness.
|
Change from baseline to 60 minutes and 120 minutes.
|
Cognitive Control
Time Frame: Change from baseline to 60 minutes and 120 minutes.
|
Cognitive control as measured by the Go/No-go Test.
|
Change from baseline to 60 minutes and 120 minutes.
|
Working Memory
Time Frame: Change from baseline to 60 minutes and 120 minutes.
|
Working memory as measured by the N-back Test.
|
Change from baseline to 60 minutes and 120 minutes.
|
Attention
Time Frame: Change from baseline to 60 minutes and 120 minutes.
|
Attention as measured by the Serial Sevens Test.
|
Change from baseline to 60 minutes and 120 minutes.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic blood pressure
Time Frame: Change from baseline to 60 minutes and 120 minutes.
|
Systolic blood pressure in mm of mercury.
|
Change from baseline to 60 minutes and 120 minutes.
|
Diastolic blood pressure
Time Frame: Change from baseline to 60 minutes and 120 minutes.
|
Diastolic blood pressure in mm of mercury.
|
Change from baseline to 60 minutes and 120 minutes.
|
Heart rate
Time Frame: Change from baseline to 60 minutes and 120 minutes.
|
Heart rate measured in beats per minute.
|
Change from baseline to 60 minutes and 120 minutes.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tim Ziegenfuss, PhD, The Center for Applied Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AFS-04-2023-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cognitive Change
-
University Ramon LlullAinhoa Nieto Guisado; Mònica Solana-TramuntUnknownCognitive Change | Proprioception Change | Balance ChangeSpain
-
Applied Science & Performance InstituteRecruitingCognitive Change | Mood Change | Mental ProcessesUnited States
-
National Council of Scientific and Technical Research...CompletedSleep | Cognitive Change | Mood Change | CreativityArgentina
-
Wake Forest UniversityNot yet recruiting
-
Biruni UniversityCompletedCognitive ChangeTurkey
-
University of MemphisCalerie LLCCompletedCognitive ChangeUnited States
-
Oregon Health and Science UniversityCompleted
-
University of MiamiUnited States Department of DefenseCompleted
-
Northumbria UniversityPerfetti van Melle SPACompletedCognitive ChangeUnited Kingdom
-
Universidad de GranadaCompleted
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States