Clinical Study on Anti Diabetes Collagen Peptide to Treat PreDiabetes

Phase 2

Completed

• Conditions: Health Condition 1: R730- Abnormal glucose

• Registration Number: CTRI/2022/05/042496
• Lead Sponsor: itta Gelatin India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-08-22
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Fasting Blood Glucose : 100mg/dL or Reduction of 10% from Baseline <br/ ><br>2.HbA1C : 5.7% or Reduction of 10% from Baseline <br/ ><br>3.Post Prandial Glucose (cohort only) : 140mg/dL or Reduction of 10% from BaselineTimepoint: 1.Fasting Blood Glucose : Day 1, Day 45, Day 90 <br/ ><br>2.HbA1C : Day 1, Day 45, Day 90 <br/ ><br>3.Post Prandial Glucose (cohort only) : Day 1, Day 45, Day 90 <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
oneTimepoint: None