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The Effect of Kombucha on Blood Sugar Levels in Humans

University of Missouri (MU) logo

University of Missouri (MU)

Status

Completed

Conditions

Blood Sugar; High
Glucose Metabolism Disorders (Including Diabetes Mellitus)
Glucose

Treatments

Dietary Supplement: Brewed kombucha tea
Other: Control: Water
Dietary Supplement: Commercial kombucha tea
Other: Control: Tea

Study type

Interventional

Funder types

Other

Identifiers

NCT04051294
2014707

Details and patient eligibility

About

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

Full 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

Enrollment

33 patients

Sex

All

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

33 participants in 4 patient groups, including a placebo group

Intervention group 1: commercial kombucha
Experimental group
Description:
8oz
Treatment:
Dietary Supplement: Commercial kombucha tea
Intervention group 2: brewed kombucha
Experimental group
Description:
8oz
Treatment:
Dietary Supplement: Brewed kombucha tea
Control group 1: tea
Active Comparator group
Description:
8oz
Treatment:
Other: Control: Tea
Control group 2: water
Placebo Comparator group
Description:
8oz
Treatment:
Other: Control: Water

Trial contacts and locations

1

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Central trial contact

Julie M Kapp, MPH, PhD

Data sourced from clinicaltrials.gov

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