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Dark Chocolate and Glucose Levels in Diabetes

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ClinicalTrials.gov Identifier: NCT04847999
Recruitment Status : Completed
First Posted : April 19, 2021
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Jonathan Little, University of British Columbia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Type 1 Diabetes Dietary Supplement: Dark chocolate Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Impact of Dark Chocolate Consumption on Glucose Levels of People With Diabetes
Actual Study Start Date : November 20, 2020
Actual Primary Completion Date : May 4, 2021
Actual Study Completion Date : May 4, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arms and Interventions
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Arm Intervention/treatment
Experimental: Conventional Dark Chocolate
A standard dark chocolate bar.
 Dietary Supplement: Dark chocolate
Dark chocolate
Experimental: Ross Dark Chocolate
A dark chocolate bar sweetened with stevia, erythritol, and inulin.
 Dietary Supplement: Dark chocolate
Dark chocolate


Outcome Measures
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Primary Outcome Measures :
  1. Blood glucose incremental area under the curve [ Time Frame: Throughout study completion: 0-120 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 every 15-30 minutes after consumption of chocolates. Incremental area under the curve will calculate the glucose above baseline fasting values across 120 minutes.


Secondary Outcome Measures :
  1. Peak blood glucose concentration [ Time Frame: Throughout study completion: 0-120 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 total area under the curve [ Time Frame: Throughout study completion: 0-120 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 every 15-30 minutes after consumption of chocolates. Total area under the curve will calculate the glucose above zero across 120 minutes.


Other Outcome Measures:
  1. Taste Questionnaire [ Time Frame: Throughout study completion:120 min after consumption of chocolate bar ]
    Self-reported taste of chocolate bars will be assessed by questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04847999


Locations
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Canada, British Columbia
University of British Columbia Okanagan
Kelowna, British Columbia, Canada, V1V 3G1
Sponsors and Collaborators
University of British Columbia
More Information
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Responsible Party: Jonathan Little, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT04847999    
Other Study ID Numbers: H20-02122
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases