Impact of a Low-carbohydrate Versus Low-fat Breakfast on Blood Glucose Control in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Change From Baseline Hemoglobin A1c at 12 Weeks
研究概览
简要总结
The prevalence of type 2 diabetes (T2D) is increasing worldwide, with ~380 M currently suffering from this chronic, debilitating disease. T2D is characterized by high blood glucose levels in the mornings and after meals. The largest hyperglycemic spike often occurs after breakfast. Targeting this meal may be a simple, feasible strategy to improve glycemic control and reduce risk for diabetes complications. It is hypothesized that consuming a low carbohydrate high fat (LCHF) breakfast for 3 months, when compared to a standard low-fat breakfast will improve blood glucose control, increase satiety and improve body composition in people with T2D. This information will test whether the simple dietary strategy of limiting carbohydrates at breakfast could help in managing T2D.
详细描述
A 3-month parallel-group randomized controlled trial will be conducted. Eligible participants will be randomized to either the Low-carb High-fat breakfast (LCHF, n=41) or a low-fat "standard care" control breakfast (CTL, n=41), to be consumed daily for a period of 3 months.
Due to COVID-19 pandemic, this study was adapted to be conducted remotely through video/telephone conference meetings between participants and study staff, along with mailing of study materials before and after the intervention for remote data collection.
Each group will be provided with a menu of 8 LCHF breakfasts or 8 CTL breakfasts from which to choose each morning. Breakfast options (designed by a registered dietitian) will be controlled in macronutrient content and calories (~400-500 kcal), but allow for personal preference and autonomy to promote adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •physician-diagnosed T2D of ≥1 year;
- •current HbA1c of < 8.5%;
- •BMI: >25 kg/m2; (as of July 5, 2021, BMI cut off was expanded from 25-40 kg/m2 to higher than 25kg/m2 to facilitate recruitment)
- •blood pressure of <160/99 mm Hg assessed according to guidelines;
- •non-smoking;
- •not on hormone replacement therapy, corticosteroids, or anti-inflammatory medications;
- •20-79 years old.
排除标准
- •Use of exogenous insulin;
- •taking more than 2 glucose lowering medications;
- •ongoing medical treatment for diseases such as cancer, auto-immune or inflammatory disease, liver or kidney disorders;
- •allergy, intolerance or aversion to eggs or any other dietary restrictions (e.g., vegan, breakfast skipping) that will prevent them from following the standardized study diets;
- •being unable to follow remote guidance by internet or smartphone
- •being unable to follow the controlled diet instructions;.
结局指标
主要结局
Change From Baseline Hemoglobin A1c at 12 Weeks
时间窗: Baseline to 12 weeks of diet
Hemoglobin A1c measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
次要结局
- Change From Baseline Fasting Blood Glucose at 12 Weeks(Mean values for the first 14 days (weeks 1-2) and mean values for the last 14 days (weeks 11-12) of the intervention)
- Change From Baseline Fasting Blood Insulin at 12 Weeks(Baseline to 12 weeks of diet)
- Change From Baseline Blood Lipids at 12 Weeks(Baseline to 12 weeks of diet)
- Change From Baseline Inflammation Marker High Sensitive Reactive Protein (hsCRP) at 12 Weeks(Baseline to 12 weeks of diet)
- Hunger/Satiety Levels(Weeks 1, 6 and 12)
- Dietary Intake(Mean dietary intake assessed during the 12-week intervention)
- Change From Baseline Body Weight at 12 Weeks(Baseline to 12 weeks of diet)
- Change From Baseline Body Mass Index at 12 Weeks(Baseline to 12 weeks of diet)
- Continuous Glucose Monitoring(Mean values for the first 14 days (weeks 1-2) and mean values for the last 14 days (weeks 11-12) of treatment)
研究者
Jonathan Little
Associate Professor
University of British Columbia