A randomized, multi-centre, double blind, placebo-controlled, three arm study to evaluate the safety and efficacy of iCoffee in maintaining or managing post-prandial blood glucose levels in healthy volunteers

IndusViva HealthSciences Pvt Ltd0 个研究点目标入组 80 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1.Adult males and non-pregnant females aged 18 to 55 years
•2.Subjects who agree to stop from using supplements during the study period
•3.Willing to give inform consent form
•4.Subjects willing to follow the suggested diet plan.
•5.Having a diagnosis of pre-diabetes (impaired fasting glucose or impaired glucose tolerance) and meeting one of the following criteria
•i.Fasting Plasma Glucose 100 to 125 mg/dL, fasting is defined as no caloric intake for at least 8 h, OR
•ii.2-h Post load Glucose 140 to 199 mg/dL during an OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.OR
•iii.Glycosylated hemoglobin (A1C) 5.7 to 6.4%. The test should be performed in a laboratory using a method that is NABL certified.
•6.Subject with BMI Ã¢â?°Â¥ 25 kg/m2

•1.History of Type I or Type II Diabetes Mellitus
•2.A know history or present condition of allergic response to any pharmaceutical products and supplements
•3.Any history suggestive of micro vascular or macro vascular disease
•4.Administrationofanyformofpharmacotherapyforthe management of pre-diabetes in last 3 months.
•5.Impaired renal function; eGFR <60mls/min/1.73m2.
•6.Knownhistoryofanychronicillnesstakingregular pharmacological agents.
•7.Women in child bearing age unable to practice any form of contraception
•8.Subjects who are pregnant or lactating
•9.Subjects on herbal supplements/any other wellness product
•10.History of alcohol, tobacco, substance or drug abuse
•11.Subject who has participated in a clinical study within the last 30 days prior to entering this study.
•12.Subject with hypersensitivity to any of the ingredients of the study products.
•13.Refusing consent or physician uncomfortable withpatient compliance to treatments or follow up.

发起方

IndusViva HealthSciences Pvt Ltd