Evaluating the Effects of Kombucha as a Hyperglycemic Therapeutic Agent Within Diabetic Human Subjects
Pilot Study to Evaluate Effects of Kombucha as a Hyperglycemic Therapeutic Agent Within Diabetic Human Subjects
1 other identifier
interventional
12
1 country
1
Brief 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 health, colds, infections, headaches, sleep, anxiety (GAD2), depression (PHQ2), skin health.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus
Started Nov 2019
Shorter than P25 for not_applicable diabetes-mellitus
1 active site
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
First Submitted
Initial submission to the registry
September 1, 2019
CompletedFirst Posted
Study publicly available on registry
September 27, 2019
CompletedStudy Start
First participant enrolled
November 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedJuly 30, 2020
July 1, 2020
6 months
September 1, 2019
July 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Blood Sugar Levels
outcome measure: mg/dL
10 weeks
Secondary Outcomes (5)
Gut health
10 weeks
anxiety
10 weeks
depression
10 weeks
skin health
10 weeks
vulvovaginal health
10 weeks
Study Arms (2)
Kombucha Intervention
ACTIVE COMPARATOREither 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 COMPARATOREither ginger kombucha or placebo ginger water will be given to subjects for weeks 1-4 and then the reciprocal beverage for weeks 6-10.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Allergy to kombucha ingredients
- Drinks kombucha regularly (\>3time per week)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Georgetown University MedStar Hospital
Washington D.C., District of Columbia, 20007, United States
Related Publications (1)
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.
PMID: 37588049DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2019
First Posted
September 27, 2019
Study Start
November 11, 2019
Primary Completion
May 20, 2020
Study Completion
July 1, 2020
Last Updated
July 30, 2020
Record last verified: 2020-07