NCT06417840 To Evaluate the Impact of Consumption of a Bioactive Compound on Fasting Blood Glucose Levels in Asian Indians With Pre-diabetes
| NCT ID | NCT06417840 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brightseed |
| Condition | PreDiabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2024-06-22 |
| Primary Completion | 2024-10-30 |
Trial Parameters
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Brief Summary
This is randomized placebo controlled, double-blinded, parallel arm study on free living Asian Indians. Eligible subjects will undergo one-week run-in period and subjects will be asked to maintain their usual diet and exercise regime. At the end of the run-in period, subjects fulfilling the inclusion/exclusion criteria at this stage will be randomized either to the intervention arm or control arm using computerized random number tables. The measured parameters will include, 24-h diet recall, food frequency questionnaire, anthropometry including circumferences, height and weight, and blood parameters including blood glucose (fasting), serum insulin (fasting), HbA1c and lipid profile.
Eligibility Criteria
Inclusion Criteria: 1. Fasting Blood Glucose between 100-125 mg/dL; 2. and BMI range 25-30 kg/m2; 3. and waist circumference ≥80cm for women and ≥90cm for men; Exclusion Criteria: 1. Weight loss or gain ≥4.5 kg within 90 days of visit 1. 2. Use of weight loss medications within 90 days of visit 1. 3. History of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight/fat reducing purposes. 4. Use of dietary supplements or related products that, in the judgment of the Investigator, are likely to markedly affect weight loss or appetite within 30 days of visit 1. 5. History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by the Investigator. 6. History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional. 7. Current medical diagnosis of type 1 or type 2 diabetes mellitus. 8. HbA1c ≥48 mmol/mol (6.5%) as measured at visit 1. 9. History of a chronic gastrointestinal
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