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

Cognitive Change Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06062186
• Other study ID #: AFS-04-2023-003
• Status: Completed
• Phase: N/A
• Start date: April 5, 2023
• Est. completion date: September 15, 2023

Study information

• Verified date: September 2023
• Source: The Center for Applied Health Sciences, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 15, 2023
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Change

Intervention

Dietary Supplement:
• Placebo
650 mg of placebo, given as two capsules containing maltodextrin
• AmaTea Guayusa Extract
650 mg of AmaTea Guayusa Extract, given as two capsules
• Lion's Mane
1000 mg of Lion's Mane, given as two capsules

Locations

Country	Name	City	State
United States	The Center for Applied Health Sciences	Canfield	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Center for Applied Health Sciences, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration	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.
Primary	Mental Clarity	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.
Primary	Mood	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.
Primary	Focus	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.
Primary	Productivity	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.
Primary	Stress	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.
Primary	Happiness	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.
Primary	Cognitive Control	Cognitive control as measured by the Go/No-go Test.	Change from baseline to 60 minutes and 120 minutes.
Primary	Working Memory	Working memory as measured by the N-back Test.	Change from baseline to 60 minutes and 120 minutes.
Primary	Attention	Attention as measured by the Serial Sevens Test.	Change from baseline to 60 minutes and 120 minutes.
Secondary	Systolic blood pressure	Systolic blood pressure in mm of mercury.	Change from baseline to 60 minutes and 120 minutes.
Secondary	Diastolic blood pressure	Diastolic blood pressure in mm of mercury.	Change from baseline to 60 minutes and 120 minutes.
Secondary	Heart rate	Heart rate measured in beats per minute.	Change from baseline to 60 minutes and 120 minutes.