A randomized, cross-over, double blind study to determine the glycemic index of 2 test products in healthy subjects by using in-vivo method. - Determine the Glycemic Index of Malt based test products with high fibre in healthy subjects

Hindustan Unilever Limited0 个研究点目标入组 18 人开始时间: 待定最近更新: 2022年10月17日

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•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 during screening.
•4)Subjects having fasting blood glucose levels <100mg/dL.
•5)Subjects having HbA1c level <5.7 %
•6)Subjects with Body Mass Index of 18.5 to 22.9 kg/m2 (both inclusive).
•7)Subject is in good general health as determined by the Investigator based on medical history and vital signs.
•8)Subjects should be willing and able to follow the study protocol to participate in the study.
•9)Subject must be able to understand and provide written informed consent to participate in the study.
•10)Subject is willing to refrain from vigorous physical exercise during the study period.

•1)Subject with any known food allergy or intolerance to any food or beverages.
•2)Subject taking any medication in the past one week.
•3)Subject with 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.
•4)Subject with recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 24 hours prior to the study.
•5)Subject who has participated in any clinical trial within the past 90 days with blood loss more than 450 mL.
•6)Subject on 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 subjectÃ¢â?¬•s participation in the study.
•7)Subject who has performed vigorous physical exercise in the morning on dosing day.
•8)Female subjects who are pregnant or who are on lactation.
•9)Subjects who have tested positive for HIV test.
•10)Subjects who have current or recent history (within one year of screening) of alcohol (14 units a week on a regular basis) or other substance abuse.
•11)Subjects who are users of Nicotine.
•12)Subjects who are currently smoking (or use nicotine containing products) or who have quit smoking (or using nicotine containing products) during the past 3 months.
•13)Subjects having history of Hepatitis B or C virus.

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