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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 6
- 主要终点
- serum 25-hydroxyvitamin D
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Plain Yogurt Drink
Daily intake of unfortified yogurt drink(500 ml) for 12 weeks
干预措施: Plain Yogurt Drink (Dietary Supplement)
VDR Genotype (aa)
Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks
干预措施: Fortified Yogurt Drink (Dietary Supplement)
VDR Genotype (AA)
Daily intake of yogurt drink fortified (500 ml) with 1000 IU vitamin D for 12 weeks
干预措施: Fortified Yogurt Drink (Dietary Supplement)
VDR genotype (Aa)
Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks
干预措施: Fortified Yogurt Drink (Dietary Supplement)
结局指标
主要结局
serum 25-hydroxyvitamin D
时间窗: 3 months
次要结局
- Oxidative stress markers(3 Months)
- Lipid profiles(3 Months)
- Glycemic control(3 Months)
- Inflammatory markers(3 Months)
- Blood pressure(3 Months)
研究者
Tirang R. Neyestani
associate professor
National Nutrition and Food Technology Institute