Phase 1 Study That Will Compare 12 Weeks of Supplementation With Cinnamon Extract on the Action of Insulin and Blood Sugar (Glucose) With 12 Weeks of Supplementation With a Placebo.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Insulin sensitivity measured by the euglycemic hyperinsulinemic clamp
研究概览
简要总结
The purpose of this study is to determine whether Cinnamon from the Cassae Plant is effective in the body as insulin could lower blood sugar levels.
详细描述
Insulin resistance is a condition in which body cells do not fully respond to the action of insulin, a hormone that controls the amount of sugar (glucose) in the blood. As a result, blood sugar levels become abnormally high. Insulin resistance is common in women with polycystic ovary syndrome (PCOS). This study involves the administration of a nutritional supplement (cinnamon extract). The cinnamon extract like regular cinnamon powder comes from the bark of Cinnamon Cassae plant. It is believed that cinnamon may act in the same way as insulin and therefore could potentially improve insulin resistance and help to lower blood sugar (glucose) levels.
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •20 to 40 years of age
- •Have a body mass index 25-40 kg/m2
- •Have a sedentary lifestyle (participated in less than 30 minutes of physical activity 3 days per week over the last 6 months)
- •History of irregular menstrual cycles (fewer than 6 cycles in past year)
- •Excess androgen (to be measured at screening)
- •Willing to supplement normal diet with cinnamon extract and a placebo for 12 weeks
- •You can stay overnight at Pennington Center three times over the next six months
排除标准
- •Do not meet our diagnostic criteria for polycystic ovary syndrome
- •Have heart disease, lung disease, liver disease, blood disease, kidney disease, type 1 or 2 diabetes, or any other disease that in the opinion of the doctor might make you ineligible.
- •Have cancer (active malignancy with or without concurrent chemotherapy).
- •Abuse alcohol or illegal drugs.
- •Smoke or have smoked within the previous 6 months. No smoking will be permitted during the study.
- •Have donated blood within 30 days prior to randomization date.
- •Have a hemoglobin, hematocrit, red blood cell, or iron level below the normal lower limit at screening.
- •Taking medications that alter your glucose metabolism, (30 minute or more, 4 or more times per week over the past year.)
- •Unwilling or unable to adhere to the clinical evaluation schedule over the entire six-month follow-up period.
结局指标
主要结局
Insulin sensitivity measured by the euglycemic hyperinsulinemic clamp
时间窗: 6 months
次要结局
未报告次要终点
研究者
Leanne Redman
Princiapal Investigator
Pennington Biomedical Research Center