The Effect of Kombucha on Blood Sugar Levels in Humans

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    20
  • sponsor
    University of Missouri-Columbia
Updated on 21 February 2022
Accepts healthy volunteers

Summary

As a phase 0 clinical trial, we will learn how kombucha influences glucose metabolism in humans.

Description

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

Details
Condition Glucose, Glucose Metabolism Disorders (Including Diabetes Mellitus), Blood Sugar; High
Treatment Commercial kombucha tea, Brewed kombucha tea, Control: Tea, Control: Water
Clinical Study IdentifierNCT04051294
SponsorUniversity of Missouri-Columbia
Last Modified on21 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Men or women ages 30-65 years old
English-speaking
Have transportation to campus
Overweight (BMI >= 25 kg/m2) or obese (BMI >=30 kg/m2)

Exclusion Criteria

Currently use any type of nicotine product
A diagnosis of any of the following
Diabetes (type 1 or 2)
Cancer
COPD
Chronic alcoholism
Peripheral vascular disease
Autoimmune disease
Chronic kidney disease
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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