NCT04051294

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

3.7 years

First QC Date

August 7, 2019

Last Update Submit

September 6, 2023

Conditions

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

Keywords

kombuchakombucha teateafermented food

Outcome Measures

Primary Outcomes (4)

  • Fasting blood glucose level

    Blood drawn following a 10-12 hour fast.

    Baseline

  • Fasting insulin level.

    Blood drawn following a 10-12 hour fast.

    Baseline

  • Blood glucose level

    Oral glucose tolerance test

    3 hour

  • Insulin level

    Oral glucose tolerance test

    3 hour

Secondary Outcomes (1)

  • Blood pressure

    Baseline

Study Arms (4)

Intervention group 1: commercial kombucha

EXPERIMENTAL

8oz

Dietary Supplement: Commercial kombucha tea

Intervention group 2: brewed kombucha

EXPERIMENTAL

8oz

Dietary Supplement: Brewed kombucha tea

Control group 1: tea

ACTIVE COMPARATOR

8oz

Other: Control: Tea

Control group 2: water

PLACEBO COMPARATOR

8oz

Other: Control: Water

Interventions

Commercial kombucha teaDIETARY_SUPPLEMENT

Commercially-available kombucha tea.

Intervention group 1: commercial kombucha
Brewed kombucha teaDIETARY_SUPPLEMENT

Kombucha tea brewed

Intervention group 2: brewed kombucha
Control: TeaOTHER

Tea brewed in our lab.

Control group 1: tea
Control: WaterOTHER

Tap water

Control group 2: water

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Glucose Metabolism DisordersHyperglycemia

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Julie M Kapp, MPH, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 9, 2019

Study Start

January 3, 2019

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

September 8, 2023

Record last verified: 2023-09

Locations

US(1)