Comparison of Efficacy of Vitamin D and Vitamin D-calcium Fortified Yogurt Drink on Glycemic, Metabolic, Inflammatory, Immunity and Oxidative Stress Markers in Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 主要终点
- Serum 25-hydroxyvitamin D
研究概览
简要总结
The aim of this study is to evaluate the possible effects of daily intake of yogurt drink fortified with vitamin D alone or with vitamin D + calcium on some selected glycemic, metabolic, inflammatory and oxidative stress markers in patients with type 2 diabetes (T2DM).
详细描述
ninety diabetic patients will be selected. Patients who are receiving vitamin D, calcium or omega-3 supplements within the last three months will be excluded. Patients will be assigned randomly to one of the three intervention groups. 1. Plain yogurt drink 2. Vitamin D-fortified yogurt drink 3. Vitamin D-calcium fortified yogurt drink. Each patient will consume 2 servings of yogurt drink every day for 3 months with lunch and dinner. At the first and last visits, dietary and laboratory assessments will be performed for all patients. Primary outcomes are improvement in glycemic, inflammatory and immunity markers and secondary outcome is prevention of long-term diabetic complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30 to 50 years,
- •Fasting blood glucose ≥ 126 mg/dl
排除标准
- •Receiving vitamin D or calcium or omega-3 supplements within the last three months,
- •On any medication which could potentially influence vitamin D metabolism (notably estrogens, and calcitonin) within the last three months,
- •Any other concomitant disease such as renal, hepatic, and other endocrinological disorders, and malignancies, which could influence vitamin D metabolism.
- •Receiving insulin or any change in the type and/or dose of the current hypoglycemic medications
结局指标
主要结局
Serum 25-hydroxyvitamin D
时间窗: 12-week
次要结局
- Serum High Density Lipoprotein (HDL)(12-week)
- Fasting Serum Glucose (FSG)(12-week)
- Insulin(12-week)
- Hemoglobin A1c (HbA1c)(12-week)
- Serum Triglyceride (TG)(12-week)
- Serum Total Cholesterol (Tchol)(12-week)
- Serum Low Density Lipoprotein (LDL)(12-week)
研究者
Tirang R. Neyestani
associate professor
National Nutrition and Food Technology Institute