The Effect of Kombucha on Blood Sugar Levels in Humans

NCT ID: NCT04051294

Last Updated: 2023-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-03

Study Completion Date

2022-09-30

Brief Summary

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

Detailed Description

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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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention group 1: commercial kombucha

8oz

Group Type EXPERIMENTAL

Commercial kombucha tea

Intervention Type DIETARY_SUPPLEMENT

Commercially-available kombucha tea.

Intervention group 2: brewed kombucha

8oz

Group Type EXPERIMENTAL

Brewed kombucha tea

Intervention Type DIETARY_SUPPLEMENT

Kombucha tea brewed

Control group 1: tea

8oz

Group Type ACTIVE_COMPARATOR

Control: Tea

Intervention Type OTHER

Tea brewed in our lab.

Control group 2: water

8oz

Group Type PLACEBO_COMPARATOR

Control: Water

Intervention Type OTHER

Tap water

Interventions

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Commercial kombucha tea

Commercially-available kombucha tea.

Intervention Type DIETARY_SUPPLEMENT

Brewed kombucha tea

Kombucha tea brewed

Intervention Type DIETARY_SUPPLEMENT

Control: Tea

Tea brewed in our lab.

Intervention Type OTHER

Control: Water

Tap water

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Julie Kapp

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie M Kapp, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

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University of Missouri

Columbia, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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2014707

Identifier Type: -

Identifier Source: org_study_id

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