Evaluation of Glycaemic Index of test food(s) in Healthy Adult Human Subjects using ISO 26642 method.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- To determine the glycaemic index of Test foods in healthy subjects by using the in-vivo method.
研究概览
简要总结
The objective of this study is to evaluate the glycaemic index of test food in healthy adult human subjects using the ISO 26642 method.
This is a double-blind, randomized, three-arms, three-way, Crossover, in-vivo glycaemic index study in healthy subjects.
To get 5 evaluable subjects, a maximum of 6 subjects will be enrolled.
Evaluation Visit:
There are a total of 5 visits during the study. The screening will be performed within 30 days. In all the visits overnight stay and fasting will be performed. The subject will report at the clinical site in the evening, maximum of 10 hours of fasting will be performed. No food should be allowed for the subjects after 10 pm.
Visit 1 and Visit 2 for 1st and 2nd reference food consumption respectively and Visit 3 to Visit 5 for test food 1, 2, and 3 consumption respectively. Blood will be collected before and after reference and test food consumption.
The statistical analysis will be performed after completion of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 18 to 45 years (both inclusive) at the time of consent 2) Sex: male and non-pregnant/non-lactating female.
- •Females of childbearing potential must have a negative urine pregnancy test performed on screening visits.
- •Subjects having fasting blood glucose levels <100 mg/dL.
- •Subjects with a Body Mass Index of 18.5 to 25 kg/m2 (both inclusive).
- •Subject is in good general health as determined by the Investigator on the basis of medical history and vital signs.
- •Subjects should be willing and able to follow the study protocol to participate in the study.
- •Subject must be able to understand and provide written informed consent to participate in the study.
- •Subject is willing to refrain from vigorous physical exercise during the study period.
排除标准
- •Subject has any known food allergy or intolerance to any food or beverages.
- •Subject is taking any medication in the past one week.
- •Subjects should not be taking any medications known to affect glucose tolerance (excluding oral contraceptives) — stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable 4) Subjects should not have any known food allergy or intolerance 5) Presence of any chronic disease or illness in the past three months or any clinically significant on-going chronic medical illness e.g. Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc.
- •Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of24 hours prior to the study.
- •Participation in any similar clinical trial within the past 90 days with blood loss more than 450 mL.
- •An unusual diet, special diet, for whatever reason e.g. high protein diet, low sodium diet, for two weeks prior to receiving any test food and throughout the subject’s participation in the study.
- •Subject has performed vigorous physical exercise in the morning on dosing day.
- •Pregnant or lactating females.
- •Self reported Positive HIV test.
- •History of Hepatitis B or C virus self-reported.
- •Any exceptions to the inclusion/exclusion criteria will be considered on a case-by case basis and will be documented in the case report form.
结局指标
主要结局
To determine the glycaemic index of Test foods in healthy subjects by using the in-vivo method.
时间窗: 15 minute before consumption of test food to after consumption of test food at 15, 30, 45, 60, 90 & 120 minutes
次要结局
- To assess the effect of Test foods in terms of the satiety level (for hunger, fullness & desire to eat) by using visual analogue scale based subjective questionnaires(15 minute before consumption of test food to after consumption of test food at 30, 60, 90, 120, 180 & 240 minutes)
- To assess the safety of the Test foods in terms of adverse events reported by subjects or assessed by Investigator(After consumption of test food at Day 01,Day 05,Day 09,Day 16, & Day 23)
- To assess the Calorie Index of test products containing carbohydrates using standard calculation method.(After consumption of reference food & test food on Day 1, Day 5, Day 9, Day 16, Day 23)
- To assess the Glycaemic Load of test products containing carbohydrates using standard calculation method(After consumption of reference food & test food on Day 1, Day 5, Day 9, Day 16, Day 23)