Status:
COMPLETED
Acute Effects of Naturally Occurring Tea and Coffee-based Ingredients on Cognitive Performance
Lead Sponsor:
The Center for Applied Health Sciences, LLC
Conditions:
Cognitive Change
Eligibility:
All Genders
18-50 years
Phase:
NA
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 as...
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 as...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06062186
Start Date
April 5 2023
End Date
September 15 2023
Last Update
October 2 2023
Active Locations (1)
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1
The Center for Applied Health Sciences
Canfield, Ohio, United States, 44406