Vitamin D Receptor Polymorphisms and Efficacy of Vitamin D-Fortified Yogurt Drink in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Determination of VDR Single Nucleotide Polymorphisms (SNPs ) and Their Rols in Efficacy of Vitamin D-fortified Yogurt Drink on the Metabolic-, Inflammatory - and Oxidative Stress Parameters in Type 2 Diabetic Patients

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Fortified Yogurt Drink
* Dietary Supplement: Plain Yogurt Drink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes Informed consent BMI between 25 to 35 kg/m2 Age: 30-45 years old Willingness to maintain current body weight for the duration of the study Willingness to maintain baseline lifestyle activities and routines for the duration of the study Willingness to avoid the use of all over-the-counter or prescription vitamins, dietary supplements, and herbal products during the study Exclusion Criteria: History of cardiovascular , Gastrointestinal , Renal disease and any other endocrinological disorders Subjects receiving vitamin D or omega-3 supplement Pregnancy , or lactation within the study period Treatment with insulin Treatment for weight reduction Treatment for reducing serum lipids

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Plain Yogurt Drink<br>Daily intake of unfortified yogurt drink(500 ml) for 12 weeks | Dietary Supplement: Plain Yogurt Drink<br>* Daily intake of unfortified yogurt drink(500 ml)for 12 weeks<br>* Other names: PYD;|
| Experimental: VDR Genotype (aa)<br>Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks | Dietary Supplement: Fortified Yogurt Drink<br>* Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks<br>* Other names: FYD;|
| Experimental: VDR Genotype (AA)<br>Daily intake of yogurt drink fortified (500 ml) with 1000 IU vitamin D for 12 weeks | Dietary Supplement: Fortified Yogurt Drink<br>* Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks<br>* Other names: FYD;|
| Experimental: VDR genotype (Aa)<br>Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks | Dietary Supplement: Fortified Yogurt Drink<br>* Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks<br>* Other names: FYD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum 25-hydroxyvitamin D |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control |  | 3 Months | 
| Inflammatory markers |  | 3 Months | 
| Oxidative stress markers |  | 3 Months | 
| Lipid profiles |  | 3 Months | 
| Blood pressure |  | 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D fortification, Yogurt Drink, Efficacy