Dark Chocolate and Glucose Levels in Diabetes

NCT ID: NCT04847999

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-20
• Study Completion Date: 2021-05-04

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.

Conditions

Type 2 Diabetes; Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Conventional Dark Chocolate then Ross Dark Chocolate

A Conventional dark chocolate bar will be consumed and after a 1-week washout period, Ross Dark chocolate will be consumed.

Group Type: EXPERIMENTAL

Dark chocolate

Intervention Type: DIETARY_SUPPLEMENT

Dark chocolate

Ross Dark Chocolate and then Conventional chocolate

A dark chocolate bar sweetened with stevia, erythritol, and inulin - Ross Dark Chocolate will be consumed and after a 1-week washout period, Conventional Dark chocolate will be consumed.

Group Type: EXPERIMENTAL

Dark chocolate

Intervention Type: DIETARY_SUPPLEMENT

Dark chocolate

Interventions

Dark chocolate

Dark chocolate

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Little

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of British Columbia Okanagan

Kelowna, British Columbia, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H20-02122

Identifier Type: -

Identifier Source: org_study_id