None listed
Conditions
Interventions
Intervention1: Fish Collagen Peptide (Flavored): Dosage-5 g once daily
Route-Oral
Duration-180 days
Intervention2: Bovine Collagen Peptide (Flavored): Dosage-5 g once daily
Route-Oral
Duration- 180 d
Sponsors
Nitta Gelatin India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female participants aged between 30 and 55 years. 2. Healthy participants who are not on any medications for diabetes management but have slightly higher blood glucose levels (pre-diabetic population). 3. Healthy participants with a BMI greater than 28 kg per meter square. 4. Participants must meet at least one of the following criteria: Participants with fasting blood sugar (FBS) greater than 100 mg per dL and less than 125 mg per dL. Participants with postprandial blood sugar (PPBS) greater than 140 mg per dL and less than 199 mg per dL. Participants with HbA1c levels greater than 5.7 percentage and less than 6.4 percentage. 5. Participants with no recent history of corticosteroid or collagen supplement use.
Exclusion criteria
Exclusion criteria: Participants with any of the following conditions will be excluded from the study: 1. Participants with BMI less than 28 kg per meter square. 2. Diabetic or non-diabetic individuals who do not meet the specified glycaemic ranges. 3. Participants with a history or presence of rheumatoid arthritis or other inflammatory diseases. 4. Participants with a history or presence of severe comorbid conditions, including cardiac, renal, or hepatic diseases. 5. Participants with illnesses which may conflict with the investigator s interpretation if the participated in the study. 6. Participated in another clinical drug trial within 3 months before recruitment. 7. Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline. 8. Pregnant or breastfeeding women, or women planning pregnancy during the study. 9. Know hypersensitivity to fish protein, fish, collagen, resistant dextrin, maltodextrine or any product components.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in body weight from Day 0, Day 90 and Day 180. 2. Change in fasting blood sugar (FBS) and postprandial blood sugar (PPBS) from baseline to each assessment point. (Time Point: - Day -2 to -1, 0, 7, 14, 21, 28, 60, 90, 120, 150, 180) 3. Percentage change in BMI, FBS, PPBS, HbA1c, and insulin levels from baseline to Day 180. Time Point: For HbA1c: Day -2 to -1, 14, 28, 60, 90, 180) Time Point: For Insulin Level: Day: Day -2 to -1, 14, 28, 60, 90, 180) 4. Change in tests incorporated in GLP-1 level from baseline to Day 180 (Time Point: - Day -2 to -1, 14, 28, 60, 90, 180) Timepoint: 1. (Time Point: - Day 0, Day 90, Day 180) 2. (Time Point: - Day -2 to -1, 0, 7, 14, 21, 28, 60, 90, 120, 150, 180) 3. Time Point: For HbA1c: Day -2 to -1, 14, 28, 60, 90, 180) Time Point: For Insulin Level: Day: Day -2 to -1, 14, 28, 60, 90, 180) 4. (Time Point: - Day -2 to -1, 14, 28, 60, 90, 180) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in biochemical blood parameters (e.g., lipid profile, liver function tests, renal function tests) from baseline to Day 180.Timepoint: (Time Points: Day -2 to -1, 14, 28, 60, 90, 180);Safety and tolerability outcomes assessed through adverse events (AEs), serious adverse events (SAEs), vitals, and laboratory safety parameters over the 180-day study period.Timepoint: -;Change in Quality of Life (QoL) scores based on a predefined questionnaire.Timepoint: Time frame: - Day 0, 7, 14, 21, 28, 60, 90, 120, 150, 180.;Exploratory endpoint of study: Change in New Zealand Eating Behaviour Questionnaire (NZ-EBQ) score based on predefined questionnaire.Timepoint: Time frame: - Day 0, 7, 14, 21, 28, 60, 90, 120, 150, 180. | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
IR Innovate Research Pvt. Ltd.
Outcome results
None listed