Effects of Cinnamon Spice on Postprandial Glucose and Insulin in Normal Weight and Obese Individuals With Pre-Diabetes: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- glucose
研究概览
简要总结
The objective of the proposed study is to investigate the effect of cinnamon on the postprandial glycemic response to a high glycemic index meal in normal and overweight/obese prediabetic subjects
详细描述
A randomized crossover study design will be carried out in accordance with the guidelines of the Human Subjects Protection Committee of the University of California, Los Angeles. All subjects will give written informed consent before the study begins. There will be two groups of participants (normal and overweight/obese). Each participant will consume oatmeal prepared with 1 cup of 2% milk served with or without 6 g of ground cinnamon in random sequence. At each meal consumption blood will be collected to measure postprandial glucose and insulin at 0, 30, 60, 90, 120, 150 and 180 minutes.
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
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy human adults age 20-50 years' old
- •Typically consume low fiber/polyphenol diet (beige diet)
- •normal weight individuals with a BMI of
- •to 24.9 kg/ m2 with fasting serum glucose <100 mg/dL
- •overweight/obese individuals with a BMI of 25 to 35 kg/m2 and fasting serum glucose ≥100 mg/dL and <126 mg/dL or HbA1c >5.7% and < 6.5%.
- •Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent.
排除标准
- •Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
- •Any subject currently taking blood thinning medications such as Warfarin or Coumadin
- •Any history of gastrointestinal disease or surgery except for appendectomy or cholecystectomy.
- •Eating a high fiber/polyphenol diet or taking any medication or dietary supplement which interfere with the absorption of polyphenols.
- •History of gastrointestinal surgery, diabetes mellitus, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP >160mmHg, diastolic BP >95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, laxative abuse, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history.
- •Pregnant or breastfeeding
- •Currently uses tobacco products.
- •Currently has an alcohol intake > 20 g ⁄ day;
- •Currently has a coffee intake > 3 cups ⁄ day;
- •Allergy or sensitivity to cinnamon. Subjects will be excluded if there is a prior history of such sensitivity. Since these foods are commonly eaten and allergies are rare, subjects should be aware of this sensitivity prior to entering the study. To determine this, a positive history of cinnamon ingestion without incident will be requested. In addition, any subject with a history of allergy or anaphylaxis of any kind will be excluded
- •Is lactose intolerant
- •Is unable or unwilling to comply with the study protocol.
结局指标
主要结局
glucose
时间窗: Baseline to 180 minutes
postprandial glucose reponse
insulin
时间窗: Baseline to 180 minutes
postprandial insulin response
次要结局
- glucagon(Baseline to 180 minutes)
- lipids(Baseline to 180 minutes)
- C-peptide(Baseline to 180 minutes)
研究者
Zhaoping Li
Principal Investigator
University of California, Los Angeles