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The Effect of Kombucha on Blood Sugar Levels in Humans

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ClinicalTrials.gov Identifier: NCT04051294
Recruitment Status : Not yet recruiting
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Julie Kapp, University of Missouri-Columbia

Brief Summary:
As a phase 0 clinical trial, we will learn how kombucha influences glucose metabolism in humans. This will be the third known empirical human subjects study of the effects of kombucha on human health outcomes; the first in the U.S.

Condition or disease Intervention/treatment Phase
Glucose Glucose Metabolism Disorders (Including Diabetes Mellitus) Blood Sugar; High Dietary Supplement: Commercial kombucha tea Dietary Supplement: Lab-brewed kombucha tea Other: Control: Tea Other: Control: Water Not Applicable

Detailed 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: lab brew 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: A Clinical Trial to Measure the Biochemical Response of Kombucha Tea in Humans
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group 1: commercial kombucha
8oz
Dietary Supplement: Commercial kombucha tea
Commercially-available kombucha tea.

Experimental: Intervention group 2: brewed kombucha
8oz
Dietary Supplement: Lab-brewed kombucha tea
Kombucha tea brewed in our lab.

Active Comparator: Control group 1: tea
8oz
Other: Control: Tea
Tea brewed in our lab.

Placebo Comparator: Control group 2: water
8oz
Other: Control: Water
Tap water




Primary Outcome Measures :
  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 Outcome Measures :
  1. Blood pressure [ Time Frame: Baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men or women ages 30-65 years old
  • English-speaking
  • Have transportation to campus
  • Overweight 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)
    • COPD
    • Chronic alcoholism
    • Peripheral vascular disease
    • Autoimmune disease
    • Chronic kidney disease
  • Pregnant or breastfeeding
  • Prescribed medication for hypertension, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051294


Contacts
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Contact: Julie M Kapp, MPH, PhD 5738843684 kappj@health.missouri.edu

Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Julie M Kapp, MPH, PhD University of Missouri-Columbia

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Responsible Party: Julie Kapp, Associate Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT04051294     History of Changes
Other Study ID Numbers: 2014707
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julie Kapp, University of Missouri-Columbia:
kombucha
kombucha tea
tea
fermented food
Additional relevant MeSH terms:
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Metabolic Diseases
Glucose Metabolism Disorders
Hyperglycemia