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临床试验/CTRI/2017/06/008837
CTRI/2017/06/008837已完成不适用

A study to evaluate effect of consumption of two white rice varieties on Glycaemic Index in healthy human volunteers

ITC Life Sciences and Technology Center ITC LTD1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年5月26日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
To determine the effect of two white rice varieties on glycaemic index

研究概览

简要总结

A study to evaluate effect of consumption of two white rice varieties on Glycaemic Index in healthy human volunteers-

The study duration for each subject would be up to 20 days. There is a possible screening period of up to 7 days and a treatment period of 13 days. After obtaining Informed consent, subjects will be screened for inclusion and exclusion criteria, clinical and demographic data, Physical examination, collection of anthropometric measurements, vital Signs, lab investigations (Hematology, Biochemistry, Lipid profile, Glucose, Blood Insulin and Urine analysis), UPT will be performed for female subjects before and after the study. Once all the eligibility criteria are met, participant will be enrolled to the study. Subjects will be housed at least 10-12 hr prior to dosing till 4 hr after dosing on each visit. The night meal will be served to the participants as per the Institutional standards at least 10-12hrs before the test/reference dose served as per treatment chart. Diet will be served under the supervision of delegated study team member to the subjects. Subjects will be evaluated for well-being and checked out from the facility. Concomitant medication and adverse events will be reported on each visit days during study conduct including check in and checkout days. The study end points includes-Primary endpoint Such as Measurement of Blood glucose levels at all time points including pre-dose samples. Secondary endpoint includes measurement of serum Insulin levels on all dosing days.

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

  • 1.Healthy adults (based on medical history and screening tests) age between 18 and 45 years male and female (1:1 ratio) will be enrolled into the study after written informed consent has been obtained.
  • 2.Subject is willing to give written, signed and dated informed consent to participate in the study before initiating any study related procedure.
  • 3.Fasting blood glucose levels less than 100 mg/dl 4.BMI should be between 18.5 to 25 kg/m2 5.Lipid profile (Triglycerides, Cholesterol, LDL, HDL, VLDL) within normal range as applicable to each parameter.

排除标准

  • 1.Subjects with BMI less than 18.5kg/m2 or more than 25kg/m2 will be excluded from the study.
  • 2.Fasting blood glucose levels > 100mg/dl.
  • 3.Subjects with Clinically significant Lipid profile values are excluded 4.Subjects particularly on any special diet 5.Subjects suffering with diabetes, cardiovascular, renal, pulmonary, endocrine, or neurological disorders, ulcers, dermatologic disorders, autoimmune diseases or severe food allergies; an active infectious disease (HBV, HCV,HIV); a current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders 6.Pregnant or lactating women 7.Subject having participated in any other clinical trial within one month prior to screening.

结局指标

主要结局

To determine the effect of two white rice varieties on glycaemic index

时间窗: Screening and each visit

次要结局

  • To determine the iAUC of two white rice varieties(Screening and each visit)

研究者

发起方
ITC Life Sciences and Technology Center ITC LTD
申办方类型
Other [fmcg]

研究点 (1)

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