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

Not Applicable

Completed

• Conditions: Cognitive Change
• Interventions: Dietary Supplement: Lion's Mane; Dietary Supplement: AmaTea Guayusa Extract; Dietary Supplement: Placebo

• Registration Number: NCT06062186
• Lead Sponsor: The Center for Applied Health Sciences, LLC

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.

Study Timeline

• Study Start: 2023-04-05
• Primary Completion: 2023-08-28
• Status Verified: 2023-09
• Study Completion: 2023-09-15
• Study First Submitted: 2023-09-25
• Study First Submitted QC: 2023-09-29
• Last Update Submitted: 2023-09-29
• Study First Posted: 2023-10-02
• Last Update Posted: 2023-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lion's Mane	Lion's Mane	1000 mg of Lion's Mane, given as two capsules
AmaTea Max Guayusa extract	AmaTea Guayusa Extract	650 mg of AmaTea Guayusa Extract, given as two capsules
Placebo	Placebo	650 mg of placebo, given as two capsules containing maltodextrin

Primary Outcome Measures

Name	Time	Method
Cognitive Control	Change from baseline to 60 minutes and 120 minutes.	Cognitive control as measured by the Go/No-go Test.
Mood	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.
Productivity	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.
Attention	Change from baseline to 60 minutes and 120 minutes.	Attention as measured by the Serial Sevens Test.
Concentration	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.
Focus	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.
Happiness	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.
Mental Clarity	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.
Stress	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.
Working Memory	Change from baseline to 60 minutes and 120 minutes.	Working memory as measured by the N-back Test.

Secondary Outcome Measures

Name	Time	Method
Systolic blood pressure	Change from baseline to 60 minutes and 120 minutes.	Systolic blood pressure in mm of mercury.
Diastolic blood pressure	Change from baseline to 60 minutes and 120 minutes.	Diastolic blood pressure in mm of mercury.
Heart rate	Change from baseline to 60 minutes and 120 minutes.	Heart rate measured in beats per minute.

Trial Locations

Locations (1)

The Center for Applied Health Sciences; 🇺🇸 Canfield, Ohio, United States