Pilot Study to Evaluate Effects of Kombucha as a Hyperglycemic Therapeutic Agent Within Diabetic Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Blood Sugar Levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Allergy to kombucha ingredients
- •Drinks kombucha regularly (>3time per week)
研究组 & 干预措施
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.
干预措施: Ginger Kombucha (Dietary Supplement)
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.
干预措施: Ginger Water (Dietary Supplement)
结局指标
主要结局
Blood Sugar Levels
时间窗: 10 weeks
outcome measure: mg/dL
次要结局
- Gut health(10 weeks)
- anxiety(10 weeks)
- depression(10 weeks)
- skin health(10 weeks)
- vulvovaginal health(10 weeks)