Type 2 Diabetes. Non-insulin-dependent diabetes mellitus
Conditions
Interventions
Intervention 1: Intervention Group: Yogurt drink Fortified with 500 IU Cholecalciferol per 250 ml in AA genotype subgroup. Intervention 2: Intervention Group: Yogurt drink fortified with 500 IU cholec
Treatment - Other
Placebo
Intervention Group: Yogurt drink Fortified with 500 IU Cholecalciferol per 250 ml in AA genotype subgroup
Intervention Group: Yogurt drink fortified with 500 IU cholecalciferol per 250 ml in aa genotype subgroup
Intervention Group: Yogurt drink fortified with 500 IU cholecalciferol per 250 ml in Aa genotype subgroup
Control Group: Plain yogurt drink
Sponsors
National Nutrition & Food Technology Research Institute, Shaheed Beheshti University of Medical Scie
School of Public Health, Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Fasting blood glucose = 126, 2. BMI between 25 to 35 kg/m2, 3. Age: 30-60 years old, 4. Willingness to maintain current body weight for the duration of the study, 5. Willingness to maintain baseline lifestyle activities and routines for the duration of the study, 6. Willingness to avoid the use of all over-the-counter or prescription vitamins, dietary supplements, and herbal products during the study. Exclusion criteria: 1. History of cardiovascular disease, Gastrointestinal disease, Renal disease, Kidney stone, Hyperparathyroidism, 2. Receiving vitamin D or omega-3 supplement within the last three months, 3. Pregnancy , or lactation within the study period, 4. Receiving insulin or any drug for weight reduction, reducing serum cholesterol, 5. Any change in type /or dose of the current hypoglycemic medications,
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvment in Serum Vitamin D Status. Timepoint: 3 Months. Method of measurement: Serum 25(OH)D Level. | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycemic biomarkers. Timepoint: baseline and 3 month after intervention. Method of measurement: serum fasting glucose ,Insulin, HbA1C and Quiccki index.;Anthropometric indicators. Timepoint: Baseline and 3 month after intervention. Method of measurement: Weight, Height, BMI,Hip Circumferences ? Waist Circumferences, WHR.;Albumin, total protein, BUN, AST, ALT, lipid profiles and uric acid. Timepoint: Baseline and 3 months after intervention. Method of measurement: Serum Albumin, Total protein, BUN, AST, ALT, Lipid profiles and Acid uric.;Urinary albumin, calcium, magnesium,phosphorous and micro-albumin. Timepoint: baseline and 3 month after intervention. Method of measurement: Urinary concentrations of micro-albumin, calcium, magnesium and phosphorous.;Blood pressure. Timepoint: baseline and 3 month after intervention. Method of measurement: systolic and diastolic blood pressure.;Oxidative stress biomarkers. Timepoint: baseline and 3 month after intervention. Method of measurement: serum superoxide dismutase,glutathion, glutathion peroxidase, MDA, TAC.;Inflammatory biomarkers. Timepoint: Baseline and 3 month after intervention. Method of measurement: Serum CRP,IL-6 and Il-4 , TNF-a and IFN-? concentrations in cell culture medium.;Bone biomarkers. Timepoint: baseline and 3 month after intervention. Method of measurement: serum magnesium,Phosphor, calcium, PTH,Osteocalcin. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSakineh Shab-Bidar
Public Health School,Tehran University of Medical Sciences
Outcome results
None listed