NCT06062186

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: The Center for Applied Health Sciences, LLC · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cognitive Change

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	650 mg of placebo, given as two capsules containing maltodextrin
DIETARY_SUPPLEMENT	AmaTea Guayusa Extract	650 mg of AmaTea Guayusa Extract, given as two capsules
DIETARY_SUPPLEMENT	Lion's Mane	1000 mg of Lion's Mane, given as two capsules

Timeline

• Start date: 2023-04-05
• Primary completion: 2023-08-28
• Completion: 2023-09-15
• First posted: 2023-10-02
• Last updated: 2023-10-02

Locations

1 site across 1 country: United States