CTRI/2011/06/001789已完成4 期
TO EVALUATE THE GLYCEMIC AND INSULINAEMIC RESPONSES TO A TEST PRODUCT IN HEALTHY VOLUNTEERS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
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.Volunteers Male / Females, Age between 20- 60 years.
- •2.Body mass index less than 28 kg/m2 i.e. should not be obese.
- •3.Cooperating, informed of the need and duration of the study procedures, and ready to comply.
- •4.Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives
排除标准
- •1.Subjects with any chronic illness or any clinical condition.
- •2.Fasting glucose more than 110 mg/dl.
- •3.Any major illness in the past three months or any clinically significant ongoing chronic medical illness e.g. Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc.
- •4.Any medication consumption in the past one week or suffering from any illness.
- •5.Subjects consuming alternative system medication (Eg. Ayurvedic and Homeopathic medications).
- •6.History of dehydration from diarrhea, vomiting or any other reason within a period of 1 week prior to the study.
- •7.Subjects with systolic blood pressure le than 90 mm and more than 140 mm of Hg.
- •8.Volunteers on any regular medication for any given medical illness.
- •9.Volunteers consuming any medication in the past one week.
- •10.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 subject?s participation in the study.
- •11.Consumption of alcohol / tobacco products within 48 hours prior to dosing / during the study period or difficulty in abstaining from alcohol / tobacco product for the duration of the study.
- •12.Volunteers with family history of diabetes
- •13.Volunteers with any history of food allergy
- •14.Subjects showing abnormal levels of BUN, creatinine, lipid profile, Liver Function test, Renal Function Test, CBC. (Subjects having abnormal values but are Clinically fit to participate in the trial would be enrolled in the study at Principal Investigator?s Discretion)
- •15.Triglyceride more than 400 should be excluded.
- •16.Pregnant Women (as confirmed via UPT) and lactating women.
- •17.Subject likely to undergo any surgery in the period of the study
- •18.Subjects who were on any other experimental Investigational study within last 1 month as identified during screening.
- •19.Subjects unable to comply with the protocol in the opinion of Investigators.
研究者
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