A High-protein Bedtime Snack to Control Morning Blood Glucose
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Fasting Plasma glucose
研究概览
简要总结
Approximately 3 million Canadians have type 2 diabetes, a condition where the blood sugar levels are too high, uncontrolled blood sugars lead to cardiovascular disease and other complications. Patients with type 2 diabetes are often advised to consume a snack before bed in order to help control morning blood sugar levels. However, scientific evidence for this dietary approach is limited and there is no data to help elucidate what the ideal bedtime snack is. We hypothesize that a high protein, high fat snack with very little carbohydrate, will be an effective bedtime snack for lowering morning glucose without spiking glucose levels in the night. In this study we will determine if a bedtime snack that is high in protein and fat but low in carbohydrate can help improve morning glucose control in people with type 2 diabetes. This information will provide scientific evidence for the potential health benefits of strategically-timed high protein, high fat snack consumption in people with type 2 diabetes.
详细描述
Fifteen patients with physician diagnosed type 2 diabetes (HbA1c 6.5-9%), between the ages of 30-80 years, and not on exogenous insulin therapy, will complete three, 3-day intervention periods (proof-of-concept randomized trial). Participants will consume a standardized diet for three days with either i) two hard-boiled eggs, ii) fruit yogurt; or iii) control no-bedtime snack, thirty minutes prior to bedtime. Fasting blood samples will be obtained on Day 4 in the morning after following each 3-day dietary intervention. Blood glucose will be monitored continuously across the intervention period using continuous glucose monitoring (CGM). CGM allows for the moment-to-moment changes in blood glucose to be examined for several days, allowing the unique opportunity to examine the glucose responses at different points of the day, including fasting hyperglycemia in the morning, nocturnal glucose, and postprandial glucose in response to meals. To our knowledge, CGM technology has never been used in a bedtime snacking study in type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed Type 2 Diabetes
- •HbA1c between 6.5 - 9.0%
- •No dietary restraints (lactose intolerance, dislike eggs, celiac disease)
排除标准
- •Heart attack or stroke within last year
- •Exogenous insulin
研究组 & 干预措施
High protein no carbohydrate
Dietary. Two eggs will be consumed 30 minutes prior to bedtime. Energy content of dinner will be reduced to account for the calories in the bedtime snack.
干预措施: Dietary (Other)
High protein carbohydrate containing
Dietary. A low-fat yogurt will be consumed 30 minutes prior to bedtime. Protein will be matched to the high protein bedtime snack condition. Energy content of dinner will be reduced to account for the calories in the bedtime snack.
干预措施: Dietary (Other)
Control no snack
No snack will be consumed prior to bed.
结局指标
主要结局
Fasting Plasma glucose
时间窗: Day 4
Fasting Plasma glucose
次要结局
- Fasting insulin(Average of three days during each intervention)
- Fasting continuous glucose monitoring glucose(Average of the three days during each intervention)
- postprandial glucose(Average of three days during each intervention)
- Fasting homeostasis model assessment of insulin resistance (HOMA-IR)(Day 4)
- Overnight blood glucose(Average of three days during each intervention)
- 24 h mean blood glucose(Average of three days during each intervention)
研究者
Jonathan Little
Assistant Professor
University of British Columbia