GlucoseNCT04051294
The Effect of Kombucha on Blood Sugar Levels in Humans
A study testing Commercial kombucha tea and Brewed kombucha tea in people with Glucose and Glucose Metabolism Disorders (Including Diabetes Mellitus), run by University of Missouri-Columbia at 1 site in United States.
Trial summary
As a phase 0 clinical trial, we will learn how kombucha influences glucose metabolism in humans. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose, Glucose Metabolism Disorders (Including Diabetes Mellitus), Blood Sugar; High
- What is being tested?
- Commercial kombucha tea and Brewed kombucha tea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2019to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Currently use any type of nicotine product
- A diagnosis of any of the following:
- Diabetes (type 1 or 2)
- Cancer
- COPD
- Chronic alcoholism
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial to Measure the Biochemical Response of Kombucha Tea in Humans
As a phase 0 clinical trial, we will learn how kombucha influences glucose metabolism in humans.
Read the 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)
- 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
- Being tested
- Commercial kombucha tea, Brewed kombucha tea, Control: Tea, Control: Water
- Keywords
- kombucha, kombucha tea, tea, fermented food
- Medical subject headings
- Glucose Metabolism Disorders, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercial kombucha teaDietary supplement
Commercially-available kombucha tea.
Brewed kombucha teaDietary supplement
Kombucha tea brewed
Control: TeaOther
Tea brewed in our lab.
Control: WaterOther
Tap water
| Study group | Role | What they receive |
|---|---|---|
| Intervention group 1: commercial kombucha | Experimental | 8oz Receives: Dietary Supplement: Commercial kombucha tea |
| Intervention group 2: brewed kombucha | Experimental | 8oz Receives: Dietary Supplement: Brewed kombucha tea |
| Control group 1: tea | Active comparator | 8oz Receives: Other: Control: Tea |
| Control group 2: water | Placebo comparator | 8oz Receives: Other: Control: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose level
Blood drawn following a 10-12 hour fast.
Measured: Baseline
Fasting insulin level.
Blood drawn following a 10-12 hour fast.
Measured: Baseline
Blood glucose level
Oral glucose tolerance test
Measured: 3 hour
Insulin level
Oral glucose tolerance test
Measured: 3 hour
Secondary outcomes (1)
Blood pressure
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start3 Jan 2019
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlucoseStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Kapp, University of Missouri-Columbia
- Investigators
- Julie M Kapp, MPH, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051294
- Sponsor's protocol ID
- 2014707
- Status last verified
- Sep 2023
- First submitted
- 7 Aug 2019
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Measure the Biochemical Response of Kombucha Tea in Humans
- ClinicalTrials.gov ID
- NCT04051294
- Acronym / sponsor ID
- 2014707
- Keywords
- kombucha, kombucha tea, tea, fermented food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As a phase 0 clinical trial, we will learn how kombucha influences glucose metabolism in humans.
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)
- 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention group 1: commercial kombucha | Experimental | Dietary Supplement: Commercial kombucha tea8oz |
| Intervention group 2: brewed kombucha | Experimental | Dietary Supplement: Brewed kombucha tea8oz |
| Control group 1: tea | Active comparator | Other: Control: Tea8oz |
| Control group 2: water | Placebo comparator | Other: Control: Water8oz |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (13 listed)
- Currently use any type of nicotine product
- A diagnosis of any of the following:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Commercial kombucha teaCommercially-available kombucha tea. | Dietary supplement | Intervention group 1: commercial kombucha |
| Brewed kombucha teaKombucha tea brewed | Dietary supplement | Intervention group 2: brewed kombucha |
| Control: TeaTea brewed in our lab. | Other | Control group 1: tea |
| Control: WaterTap water | Other | Control group 2: water |
Primary outcome
Fasting blood glucose level
Time frame: Baseline
Blood drawn following a 10-12 hour fast.
Fasting insulin level.
Time frame: Baseline
Blood drawn following a 10-12 hour fast.
Blood glucose level
Time frame: 3 hour
Oral glucose tolerance test
Insulin level
Time frame: 3 hour
Oral glucose tolerance test
1 secondary outcome
Blood pressure
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
Related trials for Glucose
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie M Kapp, MPH, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Commercial kombucha tea and Brewed kombucha tea in people with Glucose and Glucose Metabolism Disorders (Including Diabetes Mellitus), run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood glucose level (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.