Dark Chocolate and Glucose Levels in Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Dark Chocolate Consumption on Glucose Levels of People With Diabetes

Conditions
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Type 2 Diabetes, Type 1 Diabetes

Intervention / Treatment
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* Dietary Supplement: Dark chocolate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional Dark Chocolate<br>A standard dark chocolate bar. | Dietary Supplement: Dark chocolate<br>* Dark chocolate<br>|
| Experimental: Ross Dark Chocolate<br>A dark chocolate bar sweetened with stevia, erythritol, and inulin. | Dietary Supplement: Dark chocolate<br>* Dark chocolate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose incremental area under the curve | A self-monitoring blood glucose device (OneTouch Verio IQ® kit Blood glucose monitoring system) will be used to measure blood glucose levels before and every 15-30 minutes after consumption of chocolates. Incremental area under the curve will calculate the glucose above baseline fasting values across 120 minutes. | Throughout study completion: 0-120 min after consumption of chocolate bar | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak blood glucose concentration | Highest blood glucose value measured after consumption of the chocolate bar | Throughout study completion: 0-120 minutes after consumption of chocolate bar | 
| Peak blood glucose concentration above baseline | Highest blood glucose value above fasting baseline after consumption of the chocolate bar | Throughout study completion: 0-120 minutes after consumption of chocolate bar | 
| Blood glucose total area under the curve | A self-monitoring blood glucose device (OneTouch Verio IQ® kit Blood glucose monitoring system) will be used to measure blood glucose levels before and every 15-30 minutes after consumption of chocolates. Total area under the curve will calculate the glucose above zero across 120 minutes. | Throughout study completion: 0-120 minutes |