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

NCT06062186 | Completed

• 1 other identifier: AFS-04-2023-003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Change

Outcome Measures

Primary Outcomes (10)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Cognitive Control

  Cognitive control as measured by the Go/No-go Test.

  Change from baseline to 60 minutes and 120 minutes.

• Working Memory

  Working memory as measured by the N-back Test.

  Change from baseline to 60 minutes and 120 minutes.

• Attention

  Attention as measured by the Serial Sevens Test.

  Change from baseline to 60 minutes and 120 minutes.

Secondary Outcomes (3)

• Systolic blood pressure

  Change from baseline to 60 minutes and 120 minutes.

• Diastolic blood pressure

  Change from baseline to 60 minutes and 120 minutes.

• Heart rate

  Change from baseline to 60 minutes and 120 minutes.

Study Arms (3)

Placebo

PLACEBO COMPARATOR

650 mg of placebo, given as two capsules containing maltodextrin

Dietary Supplement: Placebo

AmaTea Max Guayusa extract

EXPERIMENTAL

650 mg of AmaTea Guayusa Extract, given as two capsules

Dietary Supplement: AmaTea Guayusa Extract

Lion's Mane

EXPERIMENTAL

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

Dietary Supplement: Lion's Mane

Interventions

Placebo DIETARY_SUPPLEMENT

650 mg of placebo, given as two capsules containing maltodextrin

Placebo

AmaTea Guayusa Extract DIETARY_SUPPLEMENT

650 mg of AmaTea Guayusa Extract, given as two capsules

AmaTea Max Guayusa extract

Lion's Mane DIETARY_SUPPLEMENT

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

Lion's Mane

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Center for Applied Health Sciences, LLC: lead

Study Sites (1)

The Center for Applied Health Sciences

Canfield, Ohio, 44406, United States

Location

Study Officials

• Tim Ziegenfuss, PhD

  The Center for Applied Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 2, 2023
• Study Start: April 5, 2023
• Primary Completion: August 28, 2023
• Study Completion: September 15, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

US (1)