Clinical trial NCT06062186: Acute Effects of Naturally Occurring Tea and Coffee-based Ingredients on Cognitive Performance
Official title: Acute Effects of Naturally Occurring Tea and Coffee-based Ingredients on Cognitive Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Lead sponsor: The Center for Applied Health Sciences, LLC
Sponsor class: INDUSTRY
First posted: 2023-10-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Concentration
timeFrame: Change from baseline to 60 minutes and 120 minutes.
measure: Mental Clarity
timeFrame: Change from baseline to 60 minutes and 120 minutes.
measure: Mood
timeFrame: Change from baseline to 60 minutes and 120 minutes.
measure: Focus
timeFrame: Change from baseline to 60 minutes and 120 minutes.
measure: Productivity
timeFrame: Change from baseline to 60 minutes and 120 minutes.
measure: Stress
timeFrame: Change from baseline to 60 minutes and 120 minutes.
measure: Happiness
timeFrame: Change from baseline to 60 minutes and 120 minutes.
measure: Cognitive Control
timeFrame: Change from baseline to 60 minutes and 120 minutes.
measure: Working Memory
timeFrame: Change from baseline to 60 minutes and 120 minutes.
measure: Attention
timeFrame: Change from baseline to 60 minutes and 120 minutes.
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: Change from baseline to 60 minutes and 120 minutes.
measure: Diastolic blood pressure
timeFrame: Change from baseline to 60 minutes and 120 minutes.
measure: Heart rate
timeFrame: Change from baseline to 60 minutes and 120 minutes.
Other outcomes:
Locations:
city: Canfield
country: United States
facility: The Center for Applied Health Sciences
state: Ohio
Study officials:
affiliation: The Center for Applied Health Sciences
name: Tim Ziegenfuss, PhD
role: PRINCIPAL_INVESTIGATOR
References: