Assessing Fermentability of a Dietary Fiber (FCHO) in Healthy Non-obese Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- The fermentation action of a dietary fiber (FCHO) provided in a breakfast test meal in relatively healthy non-obese men and women
研究概览
简要总结
The objective of this study is to provide evidence for its fermentability of a dietary fiber and to collect information regarding potential health opportunities for glucose control as well as tolerability when being consumed over 7 days.
详细描述
This study is designed as a randomized, 2-arm, treatment-controlled, within-subjects, 8-hour postprandial crossover study, utilizing a multiple sampling paradigm to evaluate fermentability and potential health opportunities for glucose control of a dietary fiber (FCHO) in healthy non-obese men and women. The study will include 2 - 8 h assessments following consumption of the FCHO drink or a placebo drink and will follow with a 7 day feeding period to assess tolerability.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •BMI between 18.5 and 29.9 kg/m2, inclusive
- •No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal, or hepatic disease
- •No diabetes
- •No Gastrointestinal issues
排除标准
- •Pregnant and/or lactating or planning for pregnancy
- •Allergies or intolerances to foods consumed in the study Fasting blood glucose > 125 mg/dL.
- •Vegetarian
- •Taking over the counter fiber supplements or other supplements that may interfere with the study procedures or endpoints
- •Taking actively probiotics or purposely taking/ subscribing to a diet high in prebiotics.
- •Taking prescription medications that may interfere with study procedures or endpoints (eg., antibiotics)
- •Subjects with unusual dietary habits (e.g. pica)
- •Actively losing weight or trying to lose weight (unstable body weight fluctuations of > 5 kg in a 60 day period)
- •Excessive exercisers or trained athletes
- •Addicted to drugs and/or alcohol
- •Medically documented psychiatric or neurological disturbances
- •Smokers (past smokers may be allowed if cessation is > 2 years)
结局指标
主要结局
The fermentation action of a dietary fiber (FCHO) provided in a breakfast test meal in relatively healthy non-obese men and women
时间窗: 8 hours
FCHO will be incorporated in a breakfast meal and compared to the same meal without the FCHO. Subjects will be served a breakfast meal with FCHO or without FCHO in a randomly assigned sequence on two separate occasions (visit 1 and visit 2) under fasting conditions. Hydrogen (H2) from breath will be measured before the breakfast test meal (baseline/fasting) and every hour: at 1hr, 2hr, 3hr, 4hr, 5hr, 6 hr, 7hr, and 8hr.
次要结局
- The changes in postprandial glucose concentrations after consuming test meals with FCHO drink compared to placebo drink(8 hours)
- The tolerability of treatments over 7 days(7 days)