A Randomized, Crossover Study to Assess the Effects of Dietary Fiber-containing Bars on Postprandial Glucose and Insulin Responses.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Change in the incremental area under the curve for capillary glucose.
研究概览
简要总结
This randomized, crossover study will include four clinic visits: one screening (day -7) and three test visits (days 0, 2, 4). The objective of this study is to assess the effects of dietary fiber-containing bars, at two doses of fiber, compared to a control product, on postprandial glucose and insulin responses in healthy adult men and women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study site will be provided pre-packaged, sealed containers of control (a bar with no fiber) and active study products (a bar with 10 grams of fiber and a bar with 20 grams of fiber). Each product container will be labeled with the lot number, expiration date, and blinded product code.
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
- •Male or female, 18-65 y of age, inclusive.
- •Subject has a body mass index of 18.5 to 32.0 kg/m, inclusive.
- •Subject is judged by the Investigator to be in generally good health on the basis of medical history and screening measurements.
- •Subject is willing to consume the study products as described in the protocol.
- •Subject is willing to maintain usual diet and activity patterns throughout the study.
- •Subject has no plans to change smoking or other nicotine use during the study period.
- •Subject is willing and able to attend all clinic visits.
- •Subject has a vein access scale score of 7-
- •Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator and is willing to complete study procedures.
排除标准
- •Individual has a clinically significant gastrointestinal, endocrine (including Type 1 and Type 2 diabetes mellitus), cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder.
- •Subject has pre-diabetes (fasting capillary glucose between 100 and 125 mg/dL) at screening. One re-test on a separate day will be allowed for subjects with no known history of pre-diabetes or diabetes who have a capillary glucose of 100 - 110 mg/dL at screening (visit 1).
- •Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at screening.
- •Individual has a history of cancer in the prior 2 years, except for non-melanoma skin cancer.
- •Individual has extreme dietary habits (e.g., Atkins, vegan).
- •Individual has had weight change of ±4.5 kg (10 lbs) in the previous 3 months.
- •Individual has a known allergy, sensitivity, or intolerance to any ingredients in the study products.
- •Individual is a female, who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
- •Individual has been exposed to any non-registered drug product within 30 days of screening.
- •Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent or comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
研究组 & 干预措施
Control bar (0 g fiber)
Each subject will be randomly assigned to consume a control sports bar-type product (0 grams of fiber) at one treatment visit.
干预措施: Control bar (0 g fiber) (Other)
Medium-fiber bar
Each subject will be randomly assigned to consume sports bar-type product (containing 10 grams of fiber) at one treatment visit.
干预措施: Medium-fiber bar (Other)
High-fiber bar
Each subject will be randomly assigned to consume sports bar-type product (containing 20 grams of fiber) at one treatment visit.
干预措施: High-fiber bar (Other)
结局指标
主要结局
Change in the incremental area under the curve for capillary glucose.
时间窗: Up to 120 minutes - measured at each treatment visit
Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for capillary glucose.
次要结局
- Change in the incremental area under the curve for venous insulin.(Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for venous glucose.)
- Change in the incremental area under the curve for venous glucose.(Up to 120 minutes - measured at each treatment visit)