Impact of Dark Chocolate Consumption on Glucose Levels of People With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Blood Glucose Incremental Area Under the Curve
研究概览
简要总结
Diabetes is a growing concern in the world with an estimated 9.3% of adults, ages 20-79, with it in 2019, type 2 diabetes accounting for 90% of this total. A common recommendation for individuals with diabetes is to limit sugars and sweets as it may cause a high blood glucose response. As a result, chocolate is often avoided due to the sugar content; though, high-polyphenol chocolate may have a beneficial effect on hyperglycaemia and vascular function. The sugar-free chocolate from Ross Chocolates is formulated with a blend of inulin, erythritol, and stevia. These alternatives to sugar are not expected to cause a significant change in blood glucose levels following consumption. The main objective of this study is to verify glucose levels before and after consumption of Ross Chocolates' blend of sweeteners dark chocolate and conventional chocolate in people with diabetes.
详细描述
Individuals with type 1 or type 2 diabetes (10 participants each) will consume a Ross Chocolate or conventional sugar-sweetened dark chocolate bar on two occasions in a randomized crossover trial. Blood glucose levels will be measured by finger prick for 120 minutes after consumption to determine postprandial glucose excursions after consumption of each type of chocolate bar.
Due to the COVID-19 pandemic, the trial was converted to be completed remotely/virtually with participants completing the testing at their home under the supervision of a research team member who will describe the study procedures and monitor testing via video conferencing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Chocolate bars will be identical and wrapped equally and labeled as A and B, by Ross Chocolates (prepared in the same mold and packaged identically) who are not involved in any other aspects of the study, allowing for blinding of research team and participants.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •physician-diagnosed T1D or T2D of ≥1 year;
- •current HbA1c of 6.5-8.5%;
- •BMI: 25-40 kg/m2;
- •blood pressure of <160/99 mm Hg assessed according to guidelines;
- •non-smoking;
- •not on hormone replacement therapy, corticosteroids, or anti-inflammatory medications;
- •18-75 years old.
排除标准
- •Are taking more than 2 glucose lowering medications;
- •Are ongoing medical treatment for diseases such as cancer, auto-immune or inflammatory disease, liver or kidney disorders;
- •Have allergy, intolerance or aversion to cocoa, stevia, erythritol, inulin, or any other dietary restrictions (e.g., vegan) that will prevent them from following the standardized study diets;
- •Are unable to follow remote guidance by internet or smartphone;
- •Are unable to follow the controlled diet instructions;
- •Are unable to read or communicate in English.
结局指标
主要结局
Blood Glucose Incremental Area Under the Curve
时间窗: 0 and 120 min after consumption of chocolate bar
A self-monitoring blood glucose device (OneTouch Verio IQ® kit Blood glucose monitoring system) will be used to measure blood glucose levels before and after consumption of chocolates. Incremental area under the curve will calculate the glucose above baseline fasting values across 120 minutes.
次要结局
- Peak Blood Glucose Concentration(0 and 120 minutes after consumption of chocolate bar)
- Peak Blood Glucose Concentration Above Baseline(Throughout study completion: 0-120 minutes after consumption of chocolate bar)
- Blood Glucose(0 and 120 minutes)
研究者
Jonathan Little
Associate Professor
University of British Columbia