Diabetes MellitusNCT04107207
Evaluating the Effects of Kombucha as a Hyperglycemic Therapeutic Agent Within Diabetic Human Subjects
A study testing Ginger Kombucha and Ginger Water in people with Diabetes Mellitus, run by Georgetown University at 1 site in United States.
Trial summary
This study's primary objective is to determine the ability of Kombucha to impact blood sugar levels in patients with diabetes mellitus type II. The secondary objective is to determine the ability of Kombucha to impact blood pressure, and quality of life measures as measured by uniform questionnaire that includes: gut… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Ginger Kombucha and Ginger Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2019to 1 Jul 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- S/he is above the age of 18
- S/he has the ability to read, speak and write English
- S/he has telephone access
- S/he is diabetic and willing to check blood sugar levels every day
- Hb A1c >7%
- Possesses a glucometer
Who cannot join
- Allergy to kombucha ingredients
- Drinks kombucha regularly (>3time per week)
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University MedStar Hospital
Washington D.C., District of Columbia, 20007
About this study
Official title: Pilot Study to Evaluate Effects of Kombucha as a Hyperglycemic Therapeutic Agent Within Diabetic Human Subjects
This study's primary objective is to determine the ability of Kombucha to impact blood sugar levels in patients with diabetes mellitus type II. The secondary objective is to determine the ability of Kombucha to impact blood pressure, and quality of life measures as measured by uniform questionnaire that includes: gut health, colds, infections, headaches, sleep, anxiety (GAD2), depression (PHQ2), skin health.
- Conditions
- Diabetes Mellitus
- Being tested
- Ginger Kombucha, Ginger Water
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginger KombuchaDietary supplement
Craft Ginger Kombucha, a fermented black tea
Ginger WaterDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Kombucha Intervention | Active comparator | Either ginger kombucha or placebo ginger water will be given to subjects for weeks 1-4 and then the reciprocal beverage for weeks 6-10. Receives: Dietary Supplement: Ginger Kombucha |
| Placebo Intervention | Placebo comparator | Either ginger kombucha or placebo ginger water will be given to subjects for weeks 1-4 and then the reciprocal beverage for weeks 6-10. Receives: Dietary Supplement: Ginger Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Sugar Levels
outcome measure: mg/dL
Measured: 10 weeks
Secondary outcomes (5)
Gut health
Worst ever | worse than usual | average | better than usual | best ever
Measured: 10 weeks
anxiety
How often have you been bothered by the following problems? 6.1. Feeling nervous, anxious or on edge Not at all | Several days | More than half the days | Nearly every day
Measured: 10 weeks
depression
How often have you been bothered by the following problems? 6.3. Little interest or pleasure in doing things Not at all | Several days | More than half the days | Nearly every day
Measured: 10 weeks
skin health
4.1. How would you rate your overall skin health? Worst ever | worse than usual | average | better than usual | best ever 5. How often do you experience skin problems such as dry skin, eczema, rashes, or acne? Not at all | Several days | More than half the days | Nearly every day
Measured: 10 weeks
vulvovaginal health
9.1. How would you rate your overall vulvovaginal health? Worst ever | worse than usual | average | better than usual | best ever
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start11 Nov 2019
- Primary completion20 May 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double blind crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107207
- Sponsor's protocol ID
- STUDY00001101
- Status last verified
- Jul 2020
- First submitted
- 1 Sep 2019
- Last updated
- 30 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mendelson C, Sparkes S, Merenstein DJ, Christensen C, Sharma V, Desale S, Auchtung JM, Kok CR, Hallen-Adams HE, Hutkins R. Kombucha tea as an anti-hyperglycemic agent in humans with diabetes - a randomized controlled pilot investigation. Front Nutr. 2023 Aug 1;10:1190248. doi: 10.3389/fnut.2023.1190248. eCollection 2023.
PubMed 37588049
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Effects of Kombucha as a Hyperglycemic Therapeutic Agent Within Diabetic Human Subjects
- ClinicalTrials.gov ID
- NCT04107207
- Acronym / sponsor ID
- STUDY00001101
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 27 Sep 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.
This study's primary objective is to determine the ability of Kombucha to impact blood sugar levels in patients with diabetes mellitus type II. The secondary objective is to determine the ability of Kombucha to impact blood pressure, and quality of life measures as measured by uniform questionnaire that includes: gut health, colds, infections, headaches, sleep, anxiety (GAD2), depression (PHQ2), skin health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double blind crossover
| Arm | Type | Receives |
|---|---|---|
| Kombucha Intervention | Active comparator | Dietary Supplement: Ginger KombuchaEither ginger kombucha or placebo ginger water will be given to subjects for weeks 1-4 and then the reciprocal beverage for weeks 6-10. |
| Placebo Intervention | Placebo comparator | Dietary Supplement: Ginger WaterEither ginger kombucha or placebo ginger water will be given to subjects for weeks 1-4 and then the reciprocal beverage for weeks 6-10. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- S/he is above the age of 18
- S/he has the ability to read, speak and write English
- S/he has telephone access
- S/he is diabetic and willing to check blood sugar levels every day
- Hb A1c >7%
Key exclusion criteria (2 listed)
- Allergy to kombucha ingredients
- Drinks kombucha regularly (>3time per week)
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 |
|---|---|---|
| Ginger KombuchaCraft Ginger Kombucha, a fermented black tea | Dietary supplement | Kombucha Intervention |
| Ginger WaterPlacebo | Dietary supplement | Placebo Intervention |
Primary outcome
Blood Sugar Levels
Time frame: 10 weeks
outcome measure: mg/dL
5 secondary outcomes
Gut health
Time frame: 10 weeks
anxiety
Time frame: 10 weeks
depression
Time frame: 10 weeks
skin health
Time frame: 10 weeks
vulvovaginal health
Time frame: 10 weeks
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 30 Jul 2020.
- Derived from this study: PubMed 37588049Mendelson C, Sparkes S, Merenstein DJ, Christensen C, Sharma V, Desale S, Auchtung JM, Kok CR, Hallen-Adams HE, Hutkins R. Kombucha tea as an anti-hyperglycemic agent in humans with diabetes - a randomized controlled pilot investigation. Front Nutr. 2023 Aug 1;10:1190248. doi: 10.3389/fnut.2023.1190248. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ginger Kombucha and Ginger Water in people with Diabetes Mellitus, run by Georgetown University 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 6 inclusion and 2 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 30 Jul 2020. 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?
Blood Sugar Levels (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04107207, which also lists 1 linked publication.
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 30 Jul 2020.