CTRI/2023/08/056087已完成Unknown
Evaluation of Glycaemic Index of test food(s) in Healthy Adult Human Subjects using ISO 26642 method. - Nil
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Age: 18 to 45 years (both inclusive) at the time of consent
- •2) Sex: male and non-pregnant/non-lactating female.
- •3) Females of childbearing potential must have a negative urine pregnancy test performed on
- •screening visits.
- •4) Subjects having fasting blood glucose levels <100 mg/dL.
- •5) Subjects with a Body Mass Index of 18.5 to 25 kg/m2 (both inclusive).
- •6) Subject is in good general health as determined by the Investigator on the basis of medical
- •history and vital signs.
- •7) Subjects should be willing and able to follow the study protocol to participate in the study.
- •8) Subject must be able to understand and provide written informed consent to participate in the
- •9) Subject is willing to refrain from vigorous physical exercise during the study period.
排除标准
- •1) Subject has any known food allergy or intolerance to any food or beverages.
- •2) Subject is taking any medication in the past one week.
- •3) 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
- •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.
- •6) Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of24 hours prior to the study.
- •7) Subject consuming any medication in the past one week.
- •8) Participation in any similar clinical trial within the past 90 days with blood loss more than 450 mL.
- •9) 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
- •10) Subject has performed vigorous physical exercise in the morning on dosing day.
- •11) Pregnant or lactating females.
- •12) Self reported Positive HIV test.
- •13) 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.
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