A Clinical Trial to Measure the Biochemical Response of Kombucha Tea in Humans
A Clinical Trial to Measure the Biochemical Response of Kombucha Tea in Humans
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)
Inclusion Criteria:
Exclusion Criteria:
Currently use any type of nicotine product
A diagnosis of any of the following:
Pregnant or breastfeeding
Prescribed medication for insulin, glucose-lowering drugs, or steroids, such as prednisone
Have routinely taken prebiotic or probiotic supplements in the past 3 months
Have routinely consumed any of the following more than one time per week in the past month: kombucha, kefir, yogurt, kimchi, cottage cheese, raw apple cider vinegar (with the "mother"), sauerkraut, kvass.