Dark Chocolate and Glucose Levels in Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04847999|
Recruitment Status : Completed
First Posted : April 19, 2021
Last Update Posted : September 28, 2021
- Study Details
- Tabular View
- Results Submitted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Type 1 Diabetes||Dietary Supplement: Dark chocolate||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|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.|
|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|
Experimental: Conventional Dark Chocolate
A standard dark chocolate bar.
Dietary Supplement: Dark chocolate
Experimental: Ross Dark Chocolate
A dark chocolate bar sweetened with stevia, erythritol, and inulin.
Dietary Supplement: Dark chocolate
- 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.
- 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
- 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
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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;
- not on hormone replacement therapy, corticosteroids, or anti-inflammatory medications;
- 18-75 years old.
- 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.
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
|Canada, British Columbia|
|University of British Columbia Okanagan|
|Kelowna, British Columbia, Canada, V1V 3G1|
|Responsible Party:||Jonathan Little, Associate Professor, University of British Columbia|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Glucose Metabolism Disorders
Endocrine System Diseases