Prediabetes. Impaired fasting glucose
Conditions
Interventions
Intervention 1: Intervention group one: Plain whey drink (without herbal ingredients) at a volume of 250 cc, containing 5 g whey and 0.7% salt. Administration: twice daily (with lunch and dinner) for
Sponsors
National Nutrition and Food Technology Research Institute
Eligibility
Sex/Gender
All
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: Willingness to cooperate Diagnosis of prediabetes Age between 20 and 50 years No smoking or alcohol use No specific diet Not pregnant or breastfeeding BMI between 25 and 29.9 No use of herbal medicines that reduce insulin and blood sugar levels No diagnosis of cardiovascular, liver, or kidney diseases.
Exclusion criteria
Exclusion criteria: Decision to change lifestyle or drug treatment during the study Unwillingness to consume whey drink Hypersensitivity to whey Hypersensitivity to herbal medicines Diagnosis of gastrointestinal diseases (irritable bowel syndrome and inflammatory bowel disease) Weight loss of more than ten percent in the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting Blood Glucose. Timepoint: Baseline (before intervention), week 6, and week 12 (end of intervention). Method of measurement: Venous blood sample after 12 hours of fasting, using an automatic biochemical analyzer (enzymatic glucose oxidase method).;Homeostasis Model Assessment of Insulin Resistance (HOMA-IR). Timepoint: Baseline and end of study (week 12). Method of measurement: Calculated as fasting blood glucose (mg/dL) multiplied by fasting insulin (µIU/mL) divided by 405. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Insulin. Timepoint: Baseline and end of study (week 12). Method of measurement: Venous blood sample after 12 hours of fasting, measured by electrochemiluminescence method (ELISA kit).;Total Cholesterol. Timepoint: Baseline and end of study (week 12). Method of measurement: Venous blood sample after 12 hours of fasting, using an automatic biochemical analyzer (enzymatic method).;Low Density Lipoprotein (LDL). Timepoint: Baseline and end of study (week 12). Method of measurement: Calculated by Friedewald formula (if triglycerides <400 mg/dL) or direct homogeneous method.;High Density Lipoprotein (HDL). Timepoint: Baseline and end of study (week 12). Method of measurement: Venous blood sample after 12 hours of fasting, using an automatic biochemical analyzer (direct enzymatic method).;Triglycerides. Timepoint: Baseline and end of study (week 12). Method of measurement: Venous blood sample after 12 hours of fasting, using an automatic biochemical analyzer (enzymatic glycerol phosphate oxidase method).;Systolic Blood Pressure. Timepoint: Baseline, week 6, and end of study (week 12). Method of measurement: Standard mercury sphygmomanometer, after 10 minutes rest in seated position.;Diastolic Blood Pressure. Timepoint: Baseline, week 6, and end of study (week 12). Method of measurement: Standard mercury sphygmomanometer, after 10 minutes rest in seated position.;Body Mass Index (BMI). Timepoint: Baseline, week 6, and end of study (week 12). Method of measurement: Calculated as weight (kg) divided by height squared (m²) – weight measured by calibrated digital scale, height measured by fixed stadiometer.;Waist Circumference. Timepoint: Baseline, week 6, and end of study (week 12). Method of measurement: Non-stretchable tape measure, midway between the lowest rib and iliac crest, standing position at the end of normal expiration. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Jalaledin Mirzay Razzaz
Shahid Beheshti University of Medical Sciences
Outcome results
None listed