NCT01936935已完成不适用
A Randomized, Controlled, Crossover Trial to Assess the Effects of Dairy Intake on Insulin Sensitivity and β-Cell Function in Men and Women at Risk for Diabetes Who Are Habitual Consumers of High Sugar Beverages
Provident Clinical Research2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2012年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Matsuda Insulin Sensitivity Index (MISI)
研究概览
简要总结
The aim of this trial is to evaluate the effects of dairy product consumption on insulin sensitivity and pancreatic β-cell function in men and women at risk for the development of type 2 diabetes mellitus (T2DM) who habitually consume beverages high in sugar (non-diet sodas and fruit juice cocktails).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subject is male or female, 18-74 yrs of age, inclusive
- •subject reports habitual consumption of ≥2 servings/d of high-sugar beverages (e.g., non-diet soda, fruit juice cocktails)
- •subject has waist circumference ≥33.0 inches for women and ≥36.0 inches for men
- •subject is at risk for development of type 2 diabetes mellitus (T2DM), based on 1 or more of the following: fasting glucose 100-125 mg/dL; glycosylated hemoglobin 5.7-6.4%, or ≥20% risk of developing diabetes in the next 7.5 yrs based on the San Antonio Heart Study prediction equation
- •subject has a score of 7-10 on the Vein Access Scale at screening
- •subject is normally active and judged to be in good health on the basis of medical history, physical examination and routine lab tests
- •if female, subject is willing to schedule treatment visits during the follicular phase of the menstrual cycle, defined as days 1-14, where day 1 is 1st day of menses
- •subject has a menstrual cycle duration ranging in length form 24-36 d (if premenopausal)
- •subject is willing to maintain a stable body weight and follow his/her habitual diet and exercise pattern, except for inclusion of study product, throughout the trial
- •subject is willing to maintain his or her habitual intake of coffee, tea, and alcoholic beverages throughout the trial
- •subject agrees to limit intake of non-study related dairy products to ≤1 serving per day during each treatment period
- •subject is ambulatory and willing to refrain from vigorous physical activity and consumption of alcoholic beverages 24 h prior to each test day
- •subject has no plans to change smoking habits during the study period
- •subject is willing to abstain from tobacco use 1 h prior to and during visits on LMTT test days
- •subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine lab test results
排除标准
- •subject has abnormal lab test results of clinical importance, including, but not limited to, TG ≥400 mg/dL, fasting creatinine ≥1.5 mg/dL, alanine aminotransferase or aspartate aminotransferase ≥1.5 times the upper limit of normal at screening
- •subject has a body mass index ≥45.0 kg/m2
- •subject has fasting blood glucose ≥126 mg/dL at screening or known diabetes mellitus (type 1 or T2DM)
- •subject has a habitual intake of ≥4 servings/d of dairy food and beverages
- •subject has known allergy or sensitivity to study product or any ingredients of study product. Subjects with lactose intolerance will be allowed to use products such as Lactaid dietary supplements
- •subject has a history of coronary heart disease, congestive heart failure, or serious ventricular dysrhythmias (ventricular tachycardia or fibrillation)
- •subject has a change in body weight of >4.5 kg within 4 weeks of screening
- •subject uses medications known to influence carbohydrate metabolism
- •subject has recent use of antibiotics
- •subject has an active infection
- •subject has unstable use of anti-hypertensive medications, thyroid hormone replacement, or lipid-altering drugs within 4 weeks of screening
- •subject has unstable use of lipid-altering foods or dietary supplements within 4 weeks of screening
- •subject uses niacin at doses >200 mg/d within 4 weeks of screening
- •subject has history of extreme dietary habits, e.g., Atkins, high protein
- •subject has a history or presence of clinically important endocrine, cardiac, renal, hepatic, pulmonary, biliary, pancreatic, gastrointestinal, or neurologic disorders that could interfere with interpretation of study results
- •subject has history of dysphagia, swallowing disorders, or intestinal motility disorders
- •subject has history of cancer
- •subject has uncontrolled hypertension at screening (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg)
结局指标
主要结局
Matsuda Insulin Sensitivity Index (MISI)
时间窗: 6 weeks
MISI calculated from glucose and insulin data obtained during a liquid meal tolerance test (LMTT). MISI = 10,000 divided by the square root of the quantity of fasting glucose x fasting insulin x mean post-load glucose from samples collected at 30, 60, 90 and 120 min after the start of the liquid meal x mean post-load insulin from samples collected at 30, 60, 90 and 120 min after the start of the liquid meal
次要结局
- Blood pressure(6 weeks)
- Glucose total area under the curve (AUC) from 0-120 min(6 weeks)
- Insulin total AUC 0-120 min(6 weeks)
- 30 min Δ insulin/Δ glucose(6 weeks)
- Plasma high-sensitivity C-reactive protein (hs-CRP)(6 weeks)
- Fasting and 2-hr LMTT insulin and glucose concentrations(6 weeks)
- Homeostasis model assessment of insulin resistance (HOMA-IR)(6 weeks)
- Homeostasis model assessment of beta-cell function (HOMA%B)(6 weeks)
- Disposition Index(6 weeks)
- Fasting plasma high-density lipoprotein cholesterol (HDL-C)(6 weeks)
- Fasting plasma TG(6 weeks)
- AUC insulin/AUC glucose(6 weeks)
- Fasting plasma total cholesterol (total-C)(6 weeks)
- Fasting plasma non-HDL-C(6 weeks)
- Serum 25-hydroxy vitamin D [25(OH)D](6 weeks)
- Waist circumference(6 weeks)
- Fasting plasma low-density lipoprotein cholesterol (LDL-C)(6 weeks)
- Fasting plasma total-C/HDL-C(6 weeks)
研究者
研究点 (2)
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