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
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- To assess glycemic index using blood sugar levels measured at fixed intervals
研究概览
简要总结
The glycemic index (GI) is a measure of the blood glucose-raisingpotential of the Carbohydrate content of a food compared to a referencefood (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 glycemicindex, 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 andmight affect the blood sugar levels whereas foods with typically less sugar andmore fibre have less glycemic index.
Subjects who fulfil the eligibility criteria will be enrolled in thestudy after signing the informed consent form.
Presentstudy is aimed to evaluate the glycemic index of four food products by Amway.This will be a single blind, repeated, cross over study in 14 subjects
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
- All
入选标准
- •1.Healthy adults (based on medical history and screening tests) in the age group of 18 and 45 years – male and female (1:1 ratio) 2.Fasting blood glucose levels < 100mg/dL.
- •3.BMI should be between 18.5 to 25 kg/m2 4.Lipid profile (Total cholesterol) within normal range as applicable 5.Agree to participate in the study 6.Able and willing to follow all study related instructions.
- •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.Subjects with BMI less than 18.5kg/m2 or more than 25kg/m2 will be excluded from the study.
- •2.Total cholesterol higher than normal range.
- •3.Subjects particularly on any special diet 4.Subjects suffering from any systemic disorders (diabetes, cardiovascular, renal, pulmonary, endocrine, or neurological disorders, ulcers, dermatologic disorders, autoimmune diseases) or severe food allergies; an active infectious disease (HBV, HCV, HIV) 5.current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders 6.Pregnant or lactating women 7.Patient having participated in any other clinical trial within one month prior to screening.
结局指标
主要结局
To assess glycemic index using blood sugar levels measured at fixed intervals
时间窗: The Glycaemic Index of the test products on Day 4, Day 7, Day 13 and Day 16 will be compared with reference product on day 1 and day 10 at Fixed intervals of -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 the study.(-Assessment adverse events during the study period.)