A Non Randomized, Open-Label, Crossover, Reference controlled clinical study to Evaluate the Glycemic Index (GI) of Food Products Compared with Glucose Reference in Healthy adults(ISO 26642 Methodology)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
This is an open-label, non-randomized, crossover interventional study designed to evaluate the glycemic index (GI) of selected food products compared with a glucose reference in healthy adult volunteers, in accordance with ISO 26642 methodology. A minimum of 10 healthy adults aged 18 to 60 years will participate in the study. Each participant will serve as their own control and will attend a total of 31 study visits, including screening, repeated reference glucose visits, and multiple test food visits, with a minimum washout period of 3 days between consecutive visits.
The order of administration of the glucose reference and test foods will be pre-specified but not balanced or randomized. Following a 10 to 12 hour overnight fast, participants will consume either the glucose reference or a test food portion containing 50 g of available carbohydrates. Blood glucose levels will be measured at baseline and at multiple time points up to 120 minutes post-consumption. The incremental area under the curve will be calculated, and the glycemic index of each test food will be determined relative to the mean response of the glucose reference.
Test food products include idly, jaggery, bread, fruit juice, carbohydrate based drinks, rice, chapati, sugar, jam, wheat pudding, payasam, gulab jamun, jalebi, peda, and additional comparable traditional food items. Each test food product will be evaluated on two separate occasions in each participant, and the resulting responses will be compared with the glucose reference.
The primary objective of the study is to determine the glycemic index of the test food products. Secondary objectives include comparison of postprandial glycemic responses, classification of foods as low, medium, or high glycemic index, and assessment of safety and tolerability. Safety will be monitored throughout all study visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.BMI 18.5 to 25 kg per m² (or as defined).
- •2.Fasting blood glucose within normal range.
- •3.Subjects with normal glucose tolerance 4.Willing to comply with study visits and procedures.
- •5.Willing to provide written informed consent.
排除标准
- •1.History of diabetes, metabolic/endocrine disorders.
- •2.Current medication affecting glucose metabolism.
- •3.Known allergies to test foods.
- •4.Pregnant/lactating women.
- •5.Chronic illness or recent major illness.
- •6.Tobacco/alcohol addiction or recent participation in another study.
研究者
Dr Priyanka Mahesh
Gita Clinic