Effect of Dietary Intervention With Dairy Products (Yoghurt) on Body Weight Management and Glycemic Control of T2DM Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Glycemic control
研究概览
简要总结
The study investigates the effects of consumption of yoghurt enriched with vitamins B compared to plain yoghurt, on body weight management and glycemic control of overweight/obese T2DM patients. It also investigates the effect of plain yoghurt consumption on gut hormones response of T2DM patients.
详细描述
In a large number of epidemiological studies, low-fat dairy consumption has been associated with lower risk of T2DM. However, the number of randomized clinical trials which examine the impact of yoghurt consumption on glycemic control and body weight management of T2DM patients is small and include yoghurts fortified with vitamin D or probiotics. According to our knowledge, fortification of yoghurt with other classes of vitamins beyond vitamin D has not been examined. Vitamins of B-complex hold key-role in energy metabolism. In the state of diabetes mellitus, the requirements for this vitamin class may be higher because of their water solubility and increased excretion. Two groups of patients participated in the study. One group received yoghurt enriched with vitamins B and one group received isocaloric plain yoghurt. In addition, in order to investigate the effect of plain yoghurt on gut hormones, responses to a mixed meal tolerance test were evaluated in the beggining and the end of the dietary intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 45 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 27-36
- •HbA1C < 8.5%
- •Constant body weight and dietary habits for the last 3 months
- •Stable dose of oral medication for at least 3 months
- •Diagnosed with T2DM for more than 1 year
排除标准
- •History of cardiovascular, gastrointestinal, renal and endocrinological diseases
- •Treatment for weight reduction
- •Lactose intolerance
- •Allergies to milk and dairy products
- •Alcohol consumption (> 2 drinks per day)
- •Intake of supplements
- •Receiving insulin
研究组 & 干预措施
Plain yoghurt
2x200g plain yoghurt/day for 12 weeks
干预措施: Plain yoghurt (Other)
Vitamin B yoghurt
2x200g yoghurt enriched with vitamins B for 12 weeks
干预措施: Vitamin B yoghurt (Other)
结局指标
主要结局
Glycemic control
时间窗: 12 weeks
Change of fasting plasma glucose after dietary intervention
Body weight management
时间窗: 12 weeks
Change of body weight after dietary intervention
次要结局
- Change of GLP-1 response(12 weeks)
- Change of ghrelin response(12 weeks)
研究者
Amalia Yanni
Research and Teaching Associate-Staff
Harokopio University
