A study to evaluate effect of consumption of food products on Glycemic index in healthy human volunteers.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- levels measured at fixed intervals.
研究概览
简要总结
The glycemic index (GI) is a measure of the blood glucose-raising potential of the Carbohydrate content of a food compared to a reference food
(generally pure glucose) (https://lpi.oregonstate.edu/mic/food-beverages/glycemic-index-glycemic-load). It is measured in a scale of 0-100 where below 55 is considered as low glycemic index, 56- 69 as medium glycemic index and 70 and above as high glycemic index. Foods that have refined sugar contents have generally more glycemic index and might affect the
blood sugar levels whereas foods with typically less sugar and more fibre have less glycemic index. Subjects who fulfil the eligibility criteria will be enrolled in the study after
signing the informed consent form. Present study is aimed to evaluate the glycemic index of Seven food products
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Healthy adults (based on medical history and screening tests) in the age group of 18 and 45 years male subjects 2.Fasting blood glucose levels less than 100mg per dL.
- •3.HOMA IR (Homeostasis Model Assessment of Insulin Resistance) less than 2.5 as per American Diabetes Association (ADA) 4.Glycosylated Hemoglobin (HbA1c) less than 5.6 as per American Diabetes Association (ADA 5.BMI should be between 18.5 to 25 kg per m2 6.Lipid profile (Total cholesterol) within normal range as applicable 7.Must be willing to give written informed consent and comply with the study procedures.
- •8.Subject’s complete blood count parameters to be within clinically acceptable range by Investigator.
排除标准
- •1.Total cholesterol higher than normal range.
- •2.Subjects particularly on any special diet 3.Subjects suffering from any systemic disorders (diabetes mellitus, cardiovascular, renal, pulmonary, endocrine, or neurological disorders, ulcers, dermatologic disorders, autoimmune diseases) or severe food allergies; an active infectious disease (HBV, HCV, HIV) 4.current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders 5.Patient having participated in any other clinical trial within one month prior to screening.
结局指标
主要结局
levels measured at fixed intervals.
时间窗: To assess glycemic index using blood sugar | levels measured at fixed intervals at 7 time points (-5, 15, 30, 45, 60, 90 and 120 min)
To assess glycemic index using blood sugar
时间窗: To assess glycemic index using blood sugar | levels measured at fixed intervals at 7 time points (-5, 15, 30, 45, 60, 90 and 120 min)
次要结局
- - To assess change in hematological and(biochemical parameters from baseline to end of)