Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Collagen Peptide: For three months 10g of Collagen Peptide to be dissolved in sufficient amount of warm water or milk (200ml) and consumed once a day.
Control Intervention1: Placebo: Fo
Sponsors
Nitta Gelatin India Limited
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female adults between the ages of 21 and 50 years (both ages inclusive). 2. Subjects with known history of diabetes mellitus (type II). 3. Subjects who are on oral hypoglycaemic agents for control of diabetes mellitus (type II). 4. Subjects who have no known history or diagnosis of complications association with diabetes mellitus (type II). 5. Subjects who are non-alcoholic and non-smokers/non-users of tobacco. 6. Subjects with Body Mass Index between 18 to 32 kg/m2 , both values inclusive. 7. Subjects with clinically normal presentations during physical examination and laboratory investigations â?? complete blood count and serum biochemistry.
Exclusion criteria
Exclusion criteria: 1. Subjects who are vegetarians or vegans or those who object to consumption of animal origin products. 2. Subjects on herbal, ayurvedic, homeopathic medications for the control of diabetes mellitus. 3. Subjects with known history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases. 4. Subjects who have undergone major surgical procedure 4 weeks prior to randomisation. 5. Subjects who are on steroids, hormone therapy, anti-depressants and anti-psychotics. 6. Subjects who have modified their dosage of primary therapy within one month prior to randomisation. 7. Subjects who are mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol. 8. Subjects who are known/reported to be pregnant, lactating, planning a pregnancy or unwilling to practice double barrier contraceptive method. 9. Subjects who in the opinion of the investigator are deemed unfit to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting Blood Glucose Levels: 125mg/dL 2. HbA1C: 6.4% A1C levels 3. Insulin Sensitivity: 25% reduction of baseline HOMA IR 4. Fasting Lipid Profile: a. LDL: Reduction of 10% of baseline LDL b. Total Cholesterol: Reduction of 10% of baseline Total Cholesterol values c. HDL: 60mg/dL d. Triglycerides: Reduction of 10% of baseline Triglycerides 5. Quality of life Questionnaire: Increase by 15 scores Timepoint: 1.Fasting Blood Glucose Levels: At V0(Week 0), V2(3 Weeks), V3 (6 Weeks), V4 (9 Weeks), V5 (12 Weeks) 2.HbA1C: At V0(Week 0), V3 (6 Weeks), V5 (12 Weeks) 3.Insulin Sensitivity: At V0(Week 0), V5 (12 Weeks) 4.Fasting Lipid Profile: At V0(Week 0), V5 (12 Weeks) 5.Quality of Life Questionnaire: At V1(Week 0), V2(3 Weeks), V3 (6 Weeks), V4 (9 Weeks), V5 (12 Weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| . Fasting Blood Glucose Levels: Reduction of 10% baseline blood glucose levels 2. HbA1C: Reduction of 10% of baseline A1C levels 3. Insulin Sensitivity: 15-24% reduction of baseline HOMA IR 4. Fasting Lipid Profile: a. LDL: Reduction of 5-9% of baseline LDL b. Total Cholesterol: Reduction of 5-9% of baseline Total Cholesterol values c. HDL: 50-59 mg/dL a. Triglycerides: Reduction of 5-9% of baseline Triglycerides 5. Quality of life Questionnaire: Increase by 14-10 scoresTimepoint: 1.Fasting Blood Glucose Levels: At V0(Week 0), V2(3 Weeks), V3 (6 Weeks), V4 (9 Weeks), V5 (12 Weeks) 2.HbA1C: At V0(Week 0), V3 (6 Weeks), V5 (12 Weeks) 3.Insulin Sensitivity: At V0(Week 0), V5 (12 Weeks) 4.Fadting Lipid Profile: At V0(Week 0), V5 (12 Weeks) 5.Quality of Life Questionnaire: At V1(Week 0), V2(3 Weeks), V3 (6 Weeks), V4 (9 Weeks), V5 (12 Weeks) | — |
Countries
India
Contacts
Public ContactDr VTSriraam
Aurous HealthCare
Outcome results
None listed