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Completed

NCT Number: NCT04847999

Dark Chocolate and Glucose Levels in Diabetes

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia Okanagan

Kelowna, British Columbia, V1V 3G1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dark chocolate

Dietary Supplement

Dark chocolate

Primary outcomes

  1. Blood Glucose Incremental Area Under the Curve

    Time frame: 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.

Secondary outcomes

  1. Peak Blood Glucose Concentration

    Time frame: 0 and 120 minutes after consumption of chocolate bar

    Highest blood glucose value measured after consumption of the chocolate bar

  2. Peak Blood Glucose Concentration Above Baseline

    Time frame: Throughout study completion: 0-120 minutes after consumption of chocolate bar

    Highest blood glucose value above fasting baseline after consumption of the chocolate bar

  3. Blood Glucose

    Time frame: 0 and 120 minutes

    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. Total area under the curve will calculate the glucose above zero across 120 minutes.

Other outcomes

  1. Taste Questionnaire - 0 to 100 Point Scale

    Time frame: Throughout study completion:120 min after consumption of chocolate bar

    Self-reported taste of chocolate bars will be assessed by questionnaire with ratings from awful (0), average (50) to fantastic (100).

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 19, 2021
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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