The Effect of Kombucha on Blood Sugar Levels in Humans

Glucose Metabolism Disorders (Including Diabetes Mellitus) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04051294
• Other study ID #: 2014707
• Status: Completed
• Phase: N/A
• Start date: January 3, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2023
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Sugar; High
• Glucose
• Glucose Metabolism Disorders
• Glucose Metabolism Disorders (Including Diabetes Mellitus)
• Hyperglycemia
• Metabolic Diseases

Intervention

Dietary Supplement:
• Commercial kombucha tea
Commercially-available kombucha tea.
• Brewed kombucha tea
Kombucha tea brewed

Other:
• Control: Tea
Tea brewed in our lab.
• Control: Water
Tap water

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting blood glucose level	Blood drawn following a 10-12 hour fast.	Baseline
Primary	Fasting insulin level.	Blood drawn following a 10-12 hour fast.	Baseline
Primary	Blood glucose level	Oral glucose tolerance test	3 hour
Primary	Insulin level	Oral glucose tolerance test	3 hour
Secondary	Blood pressure		Baseline