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| Name | Class |
|---|---|
| Tehran University of Medical Sciences | OTHER |
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Study is a 12-week Double blind,controlled experiments designed to examine the possible effects of vitamin D receptor gene polymorphisms on the metabolic, inflammatory and oxidative stress markers in type 2 diabetic patients to vitamin D-fortified yogurt drink intake.
In a 12-week randomized controlled trial ( double-blind study), based on data on serum 25(OH)D changes from other studies (35), to achieve 1 standard deviation difference in circulating 25(OH)D with two-sided alpha of 0.05 and a beta of 0.2 after a 12-week intervention period, the sample size was calculated 40 individuals per treatment group. Considering 3 polymorphic variant groups and one control group which receives plain yogurt drink, 160 subjects are needed. Allowing for 10% attrition over 12 weeks of intervention, a total of 180 subjects are required. In treatment groups, all patients receive 500 ml per day of low-fat (1%) Yogurt Drink fortified with approximately 500IU of vitamin D3 . Control group receives 500 ml per day of plain (unfortified) Yogurt Drink. Metabolic, inflammatory and oxidative stress markers are evaluated at the beginning and in the end of the interventional period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plain Yogurt Drink | Placebo Comparator | Daily intake of unfortified yogurt drink(500 ml) for 12 weeks |
|
| VDR Genotype (aa) | Experimental | Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks |
|
| VDR Genotype (AA) | Experimental | Daily intake of yogurt drink fortified (500 ml) with 1000 IU vitamin D for 12 weeks |
|
| VDR genotype (Aa) | Experimental | Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fortified Yogurt Drink | Dietary Supplement | Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| serum 25-hydroxyvitamin D | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic control | 3 Months | |
| Inflammatory markers | 3 Months | |
| Oxidative stress markers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tirang R. Neyestani, Ph.D. | National Nutrition & Food technology Research institute, P.O. Box 19395-4741 | Study Chair |
| Abolghasem Djazayeri, Professor | Tehran University of Medical Sciences | Study Chair |
| Sakineh Shab-Bidar, M.Sc. | Tehran University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Nutrition and Food Technology Research Institute | Tehran | Tehran Province | 19395-4741 | Iran | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23160722 | Derived | Neyestani TR, Djazayery A, Shab-Bidar S, Eshraghian MR, Kalayi A, Shariatzadeh N, Khalaji N, Zahedirad M, Gharavi A, Houshiarrad A, Chamari M, Asadzadeh S. Vitamin D Receptor Fok-I polymorphism modulates diabetic host response to vitamin D intake: need for a nutrigenetic approach. Diabetes Care. 2013 Mar;36(3):550-6. doi: 10.2337/dc12-0919. Epub 2012 Nov 16. | |
| 22344966 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Plain Yogurt Drink | Dietary Supplement | Daily intake of unfortified yogurt drink(500 ml)for 12 weeks |
|
|
| 3 Months |
| Lipid profiles | 3 Months |
| Blood pressure | 3 Months |
| National Nutrition and Food Technology Research Institute |
| Tehran |
| Tehran Province |
| 1981619573 |
| Iran |
| Tirang Neyestani | Tehran | Tehran Province | Iran |
| Tehran | Iran |
| Shab-Bidar S, Neyestani TR, Djazayery A, Eshraghian MR, Houshiarrad A, Kalayi A, Shariatzadeh N, Khalaji N, Gharavi A. Improvement of vitamin D status resulted in amelioration of biomarkers of systemic inflammation in the subjects with type 2 diabetes. Diabetes Metab Res Rev. 2012 Jul;28(5):424-30. doi: 10.1002/dmrr.2290. Epub 2012 Feb 17. |
| 22114787 | Derived | Shab-Bidar S, Neyestani TR, Djazayery A, Eshraghian MR, Houshiarrad A, Gharavi A, Kalayi A, Shariatzadeh N, Zahedirad M, Khalaji N, Haidari H. Regular consumption of vitamin D-fortified yogurt drink (Doogh) improved endothelial biomarkers in subjects with type 2 diabetes: a randomized double-blind clinical trial. BMC Med. 2011 Nov 24;9:125. doi: 10.1186/1741-7015-9-125. |
| 21696575 | Derived | Shab-Bidar S, Neyestani TR, Djazayery A. Efficacy of vitamin D3-fortified-yogurt drink on anthropometric, metabolic, inflammatory and oxidative stress biomarkers according to vitamin D receptor gene polymorphisms in type 2 diabetic patients: a study protocol for a randomized controlled clinical trial. BMC Endocr Disord. 2011 Jun 22;11:12. doi: 10.1186/1472-6823-11-12. |
| D004700 | Endocrine System Diseases |