Dark Chocolate and Glucose Levels in Diabetes

NCT04847999 | Completed Results

• 1 other identifier: H20-02122
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 after consumption of chocolates. Incremental area under the curve will calculate the glucose above baseline fasting values across 120 minutes.

  0 and 120 min after consumption of chocolate bar

Secondary Outcomes (3)

• 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

Other Outcomes (1)

• Taste Questionnaire - 0 to 100 Point Scale

  Throughout study completion:120 min after consumption of chocolate bar

Study Arms (2)

Conventional Dark Chocolate then Ross Dark Chocolate

EXPERIMENTAL

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

Dietary Supplement: Dark chocolate

Ross Dark Chocolate and then Conventional chocolate

EXPERIMENTAL

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.

Dietary Supplement: Dark chocolate

Interventions

Dark chocolate DIETARY_SUPPLEMENT

Dark chocolate

Conventional Dark Chocolate then Ross Dark Chocolate; Ross Dark Chocolate and then Conventional chocolate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• years old.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia Okanagan

Kelowna, British Columbia, V1V 3G1, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Limitations include small number of subjects recruited and analyzed.

Results Point of Contact

• Title: Dr Jonathan Little
• Organization: University of British Columbia

jonathan.little@ubc.ca

2508786893

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: April 19, 2021
• Study Start: November 20, 2020
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• Last Updated: February 27, 2025
• Results First Posted: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)