NCT04182971已完成不适用
Effect of Added Fruit Pomace Fiber, Juice, and Whole Fruit on Postprandial Glycemia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Glucose
研究概览
简要总结
Compare the effects of whole orange, orange juice alone, and orange juice with added orange pomace fiber, and whole apple, apple juice alone, and apple juice with added apple pomace fiber, on 2h glycemic response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 20-24.9 kg/m2 and weight >=110 lbs at screening
- •Willing to maintain usual physical activity pattern and exercise level
- •Willing to follow instructions for compliance with dietary restrictions, dosing and visits
- •In good health based on medical history
- •Willing to avoid alcohol for 24 hrs prior to visits
- •Willing to maintain stable dose of vitamins, minerals, supplements, and medications not interfering with study outcomes including birth control for the study
- •Understands procedures, signs informed consent and authorization for release of relevant protected health information and is willing to complete study procedures
排除标准
- •Fasting finger stick glucose >100
- •Uncontrolled hypertension
- •Major trauma or surgical event within 2 months of Visit 1
- •Weight change > 4.5 kg within 2 months, taking weight loss drugs, bariatric surgery, or other weight reduction surgery (liposuction, laser fat removal, etc.)
- •History or presence of clinically important endocrine, cardiovascular, pulmonary, bilary or gastrointestinal disorders that could interfere with the interpretation of study results
- •History or presence of cancer in past 2 yrs except for non-melanoma skin cancer
- •History of extreme dietary habits (Atkins, etc.)
- •History of eating disorder
- •Known intolerance or sensitivity to any of the ingredients in the study products
- •Subject has used medications know to influence carbohydrate metaboism 2 weeks prior to visit and throughout the study
- •Subject is taking systemic steroids, extreme alcohol use or drug user
- •Vein access score < 7
- •Pregnant, planning to become pregnant, or lactating
- •Current smoker or smoked within past 2 yrs
- •Has not participated in another clinical trial for past 30 days or another PepsiCo study in past 6 months
结局指标
主要结局
Glucose
时间窗: 0-120 minutes
Cmax, plasma
次要结局
- Insulin(0-120 minutes)
- Glucose(0-120 minutes)
研究者
研究点 (2)
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