A clinical study to determine the blood glucose response of a dietary fiber on high Glycemic index food and satiety response of a dietary fiber in healthy volunteers.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1. Blood glucose response of the fiber
研究概览
简要总结
This study is being performed to asses the blood glucose response of the fiber on high glycemic index food and the satiety response of the fiber in healthy volunteers. It will have 4 visits. Once the volunteer will be screened and is eligible, the Day 1 and Day 3 visit will be performed to assess the blood glucose response and Day 5 visit will be performed to assess the satiety response of the fiber.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Males or females in the age 18- 65 years (both inclusive).
- •2.Be of normal health as determined by the investigator from medical history, clinical and physical examination.
- •3.Random blood sugar level ≤ 200 mg/dl at screening.
- •4.BMI between 18.5 to 27 kg/m2 (both inclusive).
- •5.Must be willing to or likely to comply with all study requirements.
- •6.Must be able and willing to provide written informed consent.
- •7.Women of childbearing potential should have a negative pregnancy test at the time of screening and agree to use contraception during the study.
排除标准
- •1.Previous history of any clinically significant medical condition e.g. cardiovascular, type 2 diabetes mellitus, eating disorder or serious gastrointestinal indications which in opinion of investigator may jeopardize subject’s safety and preclude trial participation.
- •2.Suffering from any condition which may interfere with nutrient absorption, distribution, metabolism and excretion in opinion of the Investigator e.g. subacute obstruction.
- •3.Current use of medication which may interfere with the digestion and nutrient absorption or affect glucose tolerance and estimation in opinion of the Investigator.
- •4.Abuse of drugs or alcohol.
- •5.Known case of sensitivity to Gluten or Coeliac disease.
- •6.Pregnant or lactating women.
- •7.Currently participating or had participated in any other interventional study in last 1 month prior to screening.
- •8.Patients who are unlikely to comply with protocol requirements (e.g. non-cooperative behavior, illiterate, inability to attend study visits required by the protocol).
结局指标
主要结局
1. Blood glucose response of the fiber
时间窗: 1. Blood glucose response of the fiber 180 min post administration of fiber. | 2. Satiety response at 0 minutes, 15 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hours.
2. Change in satiety using visual analogue scale
时间窗: 1. Blood glucose response of the fiber 180 min post administration of fiber. | 2. Satiety response at 0 minutes, 15 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hours.
次要结局
未报告次要终点