As a phase 0 clinical trial, we will learn how kombucha influences glucose metabolism in humans.
Consumption of kombucha, a fermented tea beverage, has been promoted for a wide range of health benefits. However, a systematic literature review (Kapp \& Sumner, 2019) revealed a lack of evidence for human health benefit. Despite the lack of evidence, U.S. retail sales of kombucha and other fermented beverages have increased 37.4% in 2017, and kombucha is the fastest growing product in the functional beverage market. As a phase 0 clinical trial, we will learn how kombucha influences glucose metabolism in humans. We plan for 20 subjects to take part in this study. This is a randomized-controlled counter-balanced study design. Subjects will be asked to complete 4 in-person visits over 2 months time (twice per month). At the first visit, subjects will be randomized into one of four groups. At each subsequent visit, subjects will be randomized into one of the remaining groups until they have completed each arm. Arms (at least 5 subjects in each arm, minimum total=20 subjects) 1. Intervention group 1: commercial kombucha: drink 8oz kombucha 2. Intervention group 2: brewed kombucha: drink 8oz kombucha 3. Control group: drink 8oz tea (the same type as used to brew the kombucha) 4. Control group 2: drink 8oz tap water
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
33
Commercially-available kombucha tea.
Kombucha tea brewed
Tea brewed in our lab.
University of Missouri
Columbia, Missouri, United States
Fasting blood glucose level
Blood drawn following a 10-12 hour fast.
Time frame: Baseline
Fasting insulin level.
Blood drawn following a 10-12 hour fast.
Time frame: Baseline
Blood glucose level
Oral glucose tolerance test
Time frame: 3 hour
Insulin level
Oral glucose tolerance test
Time frame: 3 hour
Blood pressure
Time frame: Baseline
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Tap water