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临床试验/NCT03926806
NCT03926806已完成不适用

Effect of Dietary Intervention With Dairy Products (Yoghurt) on Body Weight Management and Glycemic Control of T2DM Patients

Harokopio University0 个研究点目标入组 33 人开始时间: 2016年11月25日最近更新:
适应症
干预措施

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

Active Comparator

2x200g plain yoghurt/day for 12 weeks

干预措施: Plain yoghurt (Other)

Vitamin B yoghurt

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amalia Yanni

Research and Teaching Associate-Staff

Harokopio University

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