An Open Label, Prospective, Non Randomised, Single Arm Pilot Clinical Study on ADCPT (Anti Diabetes Collagen Peptide) the First Line Nutritional Therapy Management in Prediabetic Adults.

itta Gelatin India Limited0 个研究点目标入组 15 人开始时间: 待定最近更新: 2023年1月9日

试验速览

暂无简介。

•1.Adults between 21 and 60 years of age (both ages and all gender inclusive) with Prediabetes
•2.Adults with Fasting Blood Glucose between 100-125 mg/dL and HbA1C between 5.7% to 6.4% at the time of screening
•3.Cohort Subjects must have Post Prandial Glucose levels between 140-199 mg/dL at the time of screening
•4.Subject/LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period.
•5.Subjects who are willing not to participate in any other clinical trial during participation in the current trial.

•1.Subjects with known hypersensitivity or vegetarians/vegans who object to consumption of animal origin investigational product.
•2.Subjects who are known/diagnosed to be Diabetic (Type I or Type II)
•3.Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
•4.Females who are pregnant or lactating or planning to become pregnant during the study period.
•5.Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
•6.Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.

发起方

itta Gelatin India Limited