Health Condition 1: R730- Abnormal glucose
Conditions
Interventions
Intervention1: ADCPT (AntiDiabetic Collagen Peptide): Dose : 5g per day (1 Sachet)
Dosage : 1 sachet per day for 90 days
Instructions for Use : Mix contents in 100ml of water and consume 30 minutes be
Sponsors
Nitta Gelatin India Limited
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Fasting Blood Glucose : 100mg/dL or Reduction of 10% from Baseline 2.HbA1C : 5.7% or Reduction of 10% from Baseline 3.Post Prandial Glucose (cohort only) : 140mg/dL or Reduction of 10% from BaselineTimepoint: 1.Fasting Blood Glucose : Day 1, Day 45, Day 90 2.HbA1C : Day 1, Day 45, Day 90 3.Post Prandial Glucose (cohort only) : Day 1, Day 45, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: None | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Aurous HealthCare R&D India Pvt. Ltd.
Outcome results
None listed