Effect of Whey Protein vs Other Proteins in the Breakfast on Appetite, Overall Postprandial Glycemia and Weight Loss, in Obese Diabetic Individuals
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 58
- 试验地点
- 3
- 主要终点
- Plasma glucose
研究概览
简要总结
The investigators hypothesis is that eating whey protein in the breakfast versus other proteins will results in higher satiety, reduced overall postprandial glycemia and more weight loss in obese diabetic individuals
详细描述
Recently we have shown that compared to low carbohydrate diet, an isocaloric diet with addition of high calorie and protein breakfast promoted sustained weight loss and prevented weight regain by reducing diet-induced compensatory changes in hunger, cravings and ghrelin suppression.
However the effect of isocaloric and isoproteic breakfast with different source of proteins, (whey vs other proteins or vs low protein in breakfast) on weight loss, appetite and on glycemic fluctuations after breakfast lunch and dinner was not explored in obese diabetic individuals.
To search whether compared to proteins like tuna, eggs and soy, the intake of whey protein in the breakfast will lead to reduced hunger and overall postprandial glycemia and will enhance weight loss in obese diabetic individuals
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
- •Subjects ≥30 and ≤70 years of age
- •BMI: 26 to 34 kg/m2)
- •Diabetes criteria
- •HbA1C: 7-9 % or
- •Habitually eat breakfast
- •Only naïve or treated with metformin.
- •Those with anti-hypertensive and lipid-lowering medication will be included.
- •. Not dieting and no change in body weight >10 lb = 4.5 kg within the last 6 months
- •10.Those who provide signed informed consent 11.Stable physical activity pattern during the three months immediately preceding study initiation.
- •Normal liver, kidney and thyroid function.
- •Negative urinary microalbumin test (urMA) and estimated glomerular filtration rate (GFR) > 60 mL/min/1.73 m2.
排除标准
- •Type 1 Diabetes
- •Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease
- •Anemia (Hg > 10 g/dL)
- •Serum creatinine level < 1.5 mg/dl
- •Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery.
- •Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase and/or aspartate
- •Infectious disease
- •Pregnant women or lactating
- •Known hypersensitivity to milk components
- •Participating in dietary program or using of weight-loss medications
- •Documented or suspected history (within one year) of illicit drug abuse or alcoholism.
- •Use of psychotropic, anorectic or steroid medication during the month immediately prior to study onset
结局指标
主要结局
Plasma glucose
时间窗: 12 weeks
Postprandial plasma glucose after breakfast, lunch and dinner
次要结局
- Plasma Insulin(12 weeks)
- Hunger(12 weeks)
- Satiety(12 weeks)
- Change in body weight(12 weeks)
研究者
Daniela Jakubowicz, MD
MD
Hospital de Clinicas Caracas