Diabetes Mellitus
Conditions
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.
Interventions
DIETARY_SUPPLEMENTGinger Kombucha
Craft Ginger Kombucha, a fermented black tea
DIETARY_SUPPLEMENTGinger Water
Placebo
Sponsors
Georgetown University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Double blind crossover
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Sugar Levels | 10 weeks | outcome measure: mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gut health | 10 weeks | Worst ever \| worse than usual \| average \| better than usual \| best ever |
| anxiety | 10 weeks | 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 |
| depression | 10 weeks | 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 |
| skin health | 10 weeks | 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 |
| vulvovaginal health | 10 weeks | 9.1. How would you rate your overall vulvovaginal health? Worst ever \| worse than usual \| average \| better than usual \| best ever |
Countries
United States
Outcome results
None listed