Clinical trial NCT04847999: Dark Chocolate and Glucose Levels in Diabetes
Official title: Impact of Dark Chocolate Consumption on Glucose Levels of People With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Type 1 Diabetes
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood Glucose Incremental Area Under the Curve
timeFrame: 0 and 120 min after consumption of chocolate bar
Secondary outcomes:
measure: Peak Blood Glucose Concentration
timeFrame: 0 and 120 minutes after consumption of chocolate bar
measure: Peak Blood Glucose Concentration Above Baseline
timeFrame: Throughout study completion: 0-120 minutes after consumption of chocolate bar
measure: Blood Glucose
timeFrame: 0 and 120 minutes
Other outcomes:
measure: Taste Questionnaire - 0 to 100 Point Scale
timeFrame: Throughout study completion:120 min after consumption of chocolate bar
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia Okanagan
state: British Columbia
Study officials:
References: