Evaluating the Effects of Kombucha as a Hyperglycemic Therapeutic Agent Within Diabetic Human Subjects

NCT ID: NCT04107207

Last Updated: 2020-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-11

Study Completion Date

2020-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double blind crossover
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Kombucha Intervention

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.

Group Type ACTIVE_COMPARATOR

Ginger Kombucha

Intervention Type DIETARY_SUPPLEMENT

Craft Ginger Kombucha, a fermented black tea

Placebo Intervention

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.

Group Type PLACEBO_COMPARATOR

Ginger Water

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Ginger Kombucha

Craft Ginger Kombucha, a fermented black tea

Intervention Type DIETARY_SUPPLEMENT

Ginger Water

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. S/he is above the age of 18
2. S/he has the ability to read, speak and write English
3. S/he has telephone access
4. S/he is diabetic and willing to check blood sugar levels every day
5. Hb A1c \>7%
6. Possesses a glucometer

Exclusion Criteria

1. Allergy to kombucha ingredients
2. Drinks kombucha regularly (\>3time per week)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Georgetown University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Georgetown University MedStar Hospital

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37588049 (View on PubMed)

Other Identifiers

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STUDY00001101

Identifier Type: -

Identifier Source: org_study_id

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