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Completed

NCT Number: NCT04051294

The Effect of Kombucha on Blood Sugar Levels in Humans

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

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri

Columbia, Missouri, 65212, United States

About this study

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)

  • Intervention group 1: commercial kombucha: drink 8oz kombucha
  • Intervention group 2: brewed kombucha: drink 8oz kombucha
  • Control group: drink 8oz tea (the same type as used to brew the kombucha)
  • Control group 2: drink 8oz tap water

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Commercial kombucha tea

Dietary Supplement

Commercially-available kombucha tea.

Brewed kombucha tea

Dietary Supplement

Kombucha tea brewed

Control: Tea

Other

Tea brewed in our lab.

Control: Water

Other

Tap water

Primary outcomes

  1. Fasting blood glucose level

    Time frame: Baseline

    Blood drawn following a 10-12 hour fast.

  2. Fasting insulin level.

    Time frame: Baseline

    Blood drawn following a 10-12 hour fast.

  3. Blood glucose level

    Time frame: 3 hour

    Oral glucose tolerance test

  4. Insulin level

    Time frame: 3 hour

    Oral glucose tolerance test

Secondary outcomes

  1. Blood pressure

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

A Clinical Trial to Measure the Biochemical Response of Kombucha Tea in Humans

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2019
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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