Effect of Chronic Administration of Whey Protein on HbA1c and Postprandial Glycemia in Type 2 Diabetic Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Fasting circulating levels of HbA1c
研究概览
简要总结
The objectives of this study are to examine the effects of chronic, (12 weeks) administration of Whey protein on HbA1c, and postprandial glucose (PPG).
详细描述
Whey protein that accounts for 20% of whole milk protein seems to induce insulinotropic /β-cell-stimulating and glucose lowering effects via bioactive peptides generated during its gastrointestinal digestion. These bioactive peptides stimulate the release of GLP-1, serve as endogenous inhibitors of DPP-4 and cause inhibitory activity against α-glucosidase activity, which might be an additional mechanism accounting for the glucose lowering effects of Whey.
In the investigators previous study, the acute administration with Whey protein resulted in postprandial insulinotropic and glucose lowering effects in type 2 diabetic subjects. This was associated with increased postprandial response of the total-GLP-1 and of intact-GLP-1, suggesting that the peptides generated from Whey protein may have dual beneficial effects (increasing incretin production and decreasing incretin degradation by DPP-4) on glycemia regulation in subjects with type 2 diabetes.
Addition of Whey protein to the meal, significantly decreased PPG in healthy and in type 2 diabetic subjects and there are also clinical evidence in non-diabetics individuals, that acute and chronic administration of Whey protein has antihypertensive activity.
The effect of chronic administration of Whey protein on HbA1c and PPG have not been examined previously in type 2 diabetics.
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
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes patients
- •HbA1C > 7.5%
- •Duration of diabetes: < 20 years
- •Subjects ≥ 30 and ≤70 years of age
- •BMI: 22 to 35 kg/m2
- •All oral antidiabetic treatments will be allowed. No insulin
- •Normal liver and kidney function
- •Normal thyroid function
- •Stable physical activity pattern during the three months immediately preceding study
- •No metabolic disease other than diabetes
- •Normal TSH and FT4 levels
- •Acceptable health beside diabetes based on interview, medical history, physical examination, and laboratory tests
- •Read and understood the informed consent form and signed it voluntarily
排除标准
- •Type 1 diabetes
- •Treatment with Insulin
- •Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease
- •Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)
- •Pregnancy or lactation
- •Illicit drug abuse or alcoholism
- •Subjects taking anoretic drugs during the month immediately prior to study
- •Subjects on steroid treatment
- •Those with major illnesses, liver, heart, kidney, lung, infectious, neurological, psychiatric, immunological or neoplastic diseases,
- •Those with eating disorders
- •Known hypersensitivity to milk components
- •Subjects after bariatric surgery, will be excluded
- •Subjects known by the principal investigator to be unable to cooperate for any reason.
研究组 & 干预措施
Whey Protein (WPC) at breakfast
The subjects in Whey Protein (WPC) group will consume WPC (35gr) powder in bottles mixed with 250 ml milk, making a total of 42 g protein, at breakfast, for 12 weeks.
干预措施: Whey Protein (WPC) at breakfast (Dietary Supplement)
Other Protein Sources at breakfast
The subjects will consume also 42 g protein at breakfast but from different source, for 12 weeks.
干预措施: Other Protein Sources at breakfast (Dietary Supplement)
Low Protein at breakfast
The subjects will consume 17 g protein breakfast namely from soy for 12 weeks.
干预措施: Low Protein at breakfast (Dietary Supplement)
结局指标
主要结局
Fasting circulating levels of HbA1c
时间窗: 3 month
In all 60 subjects we will evaluate at baseline and after three month of consumption of WPC or Protein from other source or Low Protein at breakfast the effects on fasting circulating levels of HbA1c.
次要结局
- Body Weight(3 months)
- Postprandial Glucose(3 month)
研究者
Daniela Jakubowicz
Prof. Daniela Jakubowicz MD
Hospital de Clinicas Caracas