CTRI/2013/01/003284已完成4 期
TO EVALUATE THE GLYCEMIC AND INSULINAEMIC RESPONSES OF A TEST PRODUCT (NUTRIOSE®FB06) IN HEALTHY VOLUNTEERS.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
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 >18.5 and < 25 kg/m2 i.e. should not be overweight or 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 >110 mg/dl.
- •3.Any chronic illness or bowel diseases in the past three months or any clinically significant ongoing chronic medical illness e.g. Congestive cardiac failure, Hepatitis, Hypotensive episodes, diabetes, crohn disease etc.
- •4.Any medication consumption in the last 2 weeks or suffering from any illness.
- •5.History of dehydration from diarrhea, vomiting or any other reason within a period of 1 week prior to the study.
- •6.Subjects with systolic blood pressure <90 mm and >140 mm of Hg.
- •7.Volunteers on any regular medication for any given medical illness.
- •8.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 subjectâ??s participation in the study.
- •9.Subjects consuming more than 3 glasses of alcohol per day and /or consuming 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.
- •10.Subject not able to moderate their level of physical activity and to refrain high physical activity before each test sessions.
- •11.Subject not able to fast for 12 hours overnight before each test sessions.
- •12.Subjects who consume more than 3 glasses of alcohol per day
- •13.Subjects who donâ??t want to limit its consumption of isabgol (psyllium seed husk), wheat bran and similar types of fibers for 48 hours before the study.
- •14.Subjects who consume dietary supplements like probiotics or prebiotics.
- •15.Volunteers with family history of diabetes
- •16.Volunteers with any history of food allergy
- •17.Subjects with abnormal BUN, Creatinine, and Liver Function Tests as seen by Biochemical evaluation on the screening visit (unless otherwise decided by Investigator).
- •18.Subjects showing abnormal levels CBC. (Subjects having abnormal values but are Clinically fit to participate in the trial would be enrolled in the study at Principal Investigatorâ??s Discretion)
- •19.Pregnant Women (as confirmed via UPT) and lactating women.
- •20.Subject likely to undergo any surgery in the period of the study
- •21.Subjects who were on any other experimental Investigational study within last 1 month as identified during screening.
- •22.Subjects unable to comply with the protocol in the opinion of Investigators.
- •23.Subjects consuming alternative system medication (E.g. Ayurvedic and Homeopathic medications) for improving digestion, managing constipation and manage blood sugar levels.
- •24.Serum Triglycerides > 400 mg/dl should be excluded.
研究者
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