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Completed

NCT Number: NCT04107207

Evaluating the 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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgetown University MedStar Hospital

Washington D.C., District of Columbia, 20007, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Allergy to kombucha ingredients
  • Drinks kombucha regularly (>3time per week)

Treatment and study plan

Ginger Kombucha

Dietary Supplement

Craft Ginger Kombucha, a fermented black tea

Ginger Water

Dietary Supplement

Placebo

Primary outcomes

  1. Blood Sugar Levels

    Time frame: 10 weeks

    outcome measure: mg/dL

Secondary outcomes

  1. Gut health

    Time frame: 10 weeks

    Worst ever | worse than usual | average | better than usual | best ever

  2. anxiety

    Time frame: 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

  3. depression

    Time frame: 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

  4. skin health

    Time frame: 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

  5. vulvovaginal health

    Time frame: 10 weeks

    9.1. How would you rate your overall vulvovaginal health? Worst ever | worse than usual | average | better than usual | best ever

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Registry information

Official study title

Pilot Study to Evaluate Effects of Kombucha as a Hyperglycemic Therapeutic Agent Within Diabetic Human Subjects

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 27, 2019
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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