A Prospective, Randomised, Placebo Controlled Study to Evaluate the Impact of GLUBLOCâ„¢ on postprandial blood glucose levels in healthy individuals post carbohydrate rich meal intake.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To assess the impact of Glublocâ„¢ granules on postprandial changes in blood glucose levels post carbohydrate rich meal intake.
研究概览
简要总结
Study 1:
Design Overview
Day 1:
Following an overnight fast of at least 10 hours, subjects will be randomized to placebo and treatment arms (50 subjects per each arm). Vital signs, height and weight parameters will be collected. Baseline (0 min) reading of blood glucose levels will be recorded using Accu-Chek® Active blood glucometer (F. Hoffmann-La Roche AG), they will be randomly allocating placebo or treatment. Before taking the meal, one sachet of GLUBLOC™ granules will be sprinkled all over the food and mixed gently with a spoon. Subjects should eat the meal with in 15 minutes or less; however, post-study, there is no diet restriction for the rest of the day.
3 day washout and crossover of subjects (ie., placebo subjects will receive GLUBLOCâ„¢ and vice versa)
Day 5:
Same procedure as day 1.
Sample collection: Blood glucose levels will be measured at t30, t60, t90 & t120 minutes through a finger prick assessment with Accu-Chek® Active blood glucometer (F. Hoffmann-La Roche AG). Questions related to gastrointestinal discomfort will be asked, such as, nausea, abdominal cramp, distension and flatulence at the end of the study on day 1 and day 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Aged between 18 to 60 years BMI between 18.5 and 29.9 kg per m2 Fasting blood glucose greater than 70 mg per dl and less than or equal to 99 mg per dl.
排除标准
- •History of hypersensitivity to any of the investigational product, excipients, or Any known food allergies.
- •Pre-existing medical condition or taking medication known to affect glucose regulation or influence digestion and absorption of nutrients History of diabetes mellitus (type I or II) or they used antihyperglycemic drugs or insulin to treat diabetes or related conditions Used steroids, protease inhibitors or antipsychotic medicines as these drugs are known to impact glucose metabolism and body fat distribution.
- •Subjects with the history of uncontrolled hypertension or hyperthyroidism.
- •History of alcoholism Subjects with psychiatric or neurological disability or mental health disorder Subjects with serious health conditions such as cardiac disease, renal dysfunction, and cancers.
- •Subjects who donot have basic understanding of English language, which include speaking or writing in English.
- •Subjects who refuse to sign informed consent.
- •According to the investigators opinion, participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable.
结局指标
主要结局
To assess the impact of Glublocâ„¢ granules on postprandial changes in blood glucose levels post carbohydrate rich meal intake.
时间窗: Time points: t0 (fasting), t30, t60, t90 and t120 minutes on Day 1 & Day 5.
次要结局
- Observation of Adverse events during the study period(Day 1 & Day 5)
研究者
DR K SOMNATH GUPTA
Yashoda Hospitals