Intervention
Conditions
Brief summary
This is randomized controlled 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.
Detailed description
To study the impact of bioactive compound supplementation on fasting blood glucose. To study the impact of intervention with bioactive compound on following measures of glycaemia: * 24 hr AUC total from CGM Post-prandial glucose regulation * iAUC determined from CGM readout up to 2 hr after consumption of a Standard Meal Blood Chemistry * Fasting Insulin * HbA1c * Lipid profile Anthropometry * Weight * BMI * Waist Circumference
Interventions
extract from black pepper and hemp hull
Sponsors
Study design
Masking description
Bioactive extract vs placebo
Intervention model description
double-blind placebo controlled
Eligibility
Inclusion criteria
* Prediabetic individuals of BMI range 25-30 kg/m2 and waist circumference ≥80cm for women and ≥90cm for men with Fasting Blood Glucose between 100-125 mg/dL.
Exclusion criteria
* Prediabetic individuals of BMI range 25-30 kg/m2 and waist circumference ≥80cm for women and ≥90cm for men with Fasting Blood Glucose between 100-125 mg/dL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fasting blood glucose | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Body weight | 30 days |
Countries
India