Acute Effects of Naturally Occurring Tea and Coffee-based Ingredients on Cognitive Performance

NCT ID: NCT06062186

Last Updated: 2023-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-05
• Study Completion Date: 2023-09-15

Brief Summary

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.

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.

Conditions

Cognitive Change

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Placebo

650 mg of placebo, given as two capsules containing maltodextrin

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

650 mg of placebo, given as two capsules containing maltodextrin

AmaTea Max Guayusa extract

650 mg of AmaTea Guayusa Extract, given as two capsules

Group Type: EXPERIMENTAL

AmaTea Guayusa Extract

Intervention Type: DIETARY_SUPPLEMENT

650 mg of AmaTea Guayusa Extract, given as two capsules

Lion's Mane

1000 mg of Lion's Mane, given as two capsules

Group Type: EXPERIMENTAL

Lion's Mane

Intervention Type: DIETARY_SUPPLEMENT

1000 mg of Lion's Mane, given as two capsules

Interventions

Placebo

650 mg of placebo, given as two capsules containing maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

AmaTea Guayusa Extract

650 mg of AmaTea Guayusa Extract, given as two capsules

Intervention Type: DIETARY_SUPPLEMENT

Lion's Mane

1000 mg of Lion's Mane, given as two capsules

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Center for Applied Health Sciences, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tim Ziegenfuss, PhD

Role: PRINCIPAL_INVESTIGATOR

The Center for Applied Health Sciences

Locations

The Center for Applied Health Sciences

Canfield, Ohio, United States

Countries

United States

Other Identifiers

AFS-04-2023-003

Identifier Type: -

Identifier Source: org_study_id