Effect of a High Protein Breakfast on Glycemic Control, Insulin Sensitivity, and Beta Cell Function in Individuals With Type 2 Diabetes (T2D)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Plasma Glucose Level Post-meal (AUC [0-4])
研究概览
简要总结
This study examined the effect of a high protein or high carbohydrate breakfast on the glucose and insulin response following the breakfast meal, as well as the subsequent response following the lunch meal.
详细描述
Twelve habitual breakfast consumers with type 2 diabetes (T2D) were recruited for the study. They completed two, 7-day conditions in random order with a minimum of a 7-day washout period between study days. They consumed either a high protein (PRO) or high carbohydrate (CHO) breakfast for 6 days of acclimatization, and on the seventh day, they reported to the lab at 0700 hours following a ~12 hour overnight fast and underwent forearm catheterization before a baseline blood draw. The participants consumed the respective breakfast at ~0730 hours. Four hours post-breakfast, subjects consumed a standard lunch meal. Blood samples were taken continuously throughout the 8-hour test day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21-55 y of age
- •body mass index (BMI) between 30-40 kg/m2
- •weight stable for the prior 6 months
- •non-smokers
- •minimal alcohol consumption (< 2 drinks per day)
- •type 2 diabetic (diagnosed ≥ 2 y)
- •a fasting glucose level above 120 mg/dL
- •HbA1c between 6.5-9.0%
排除标准
- •β-blockers
- •GLP-1 agonists (e.g. exenatide)
- •dipeptidyl peptidase (DPP) inhibitors
- •weight loss
- •using weight-loss medications
- •pregnant or lactating
研究组 & 干预措施
High Carb then High Protein Breakfast
A high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat) followed by a 7-day washout period, and then 7 days of eating a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat).
干预措施: High protein breakfast (Other)
High Carb then High Protein Breakfast
A high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat) followed by a 7-day washout period, and then 7 days of eating a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat).
干预措施: High carb breakfast (Other)
High Protein then High Carb Breakfast
A high protein breakfast - 500 kcal followed by a 7-day washout period, and then 7 days of eating a high carbohydrate breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)
干预措施: High protein breakfast (Other)
High Protein then High Carb Breakfast
A high protein breakfast - 500 kcal followed by a 7-day washout period, and then 7 days of eating a high carbohydrate breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)
干预措施: High carb breakfast (Other)
结局指标
主要结局
Plasma Glucose Level Post-meal (AUC [0-4])
时间窗: 0-240 and 240-480
AUC for 4 hr after breakfast and after lunch
次要结局
- Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC)(0-240 and 240-480)
研究者
Jill Kanaley
professor
University of Missouri-Columbia