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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dark chocolate | Dietary Supplement | Dark chocolate |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Blood Glucose Concentration | Highest blood glucose value measured after consumption of the chocolate bar | 0 and 120 minutes after consumption of chocolate bar |
| Peak Blood Glucose Concentration Above Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Taste Questionnaire - 0 to 100 Point Scale | Self-reported taste of chocolate bars will be assessed by questionnaire with ratings from awful (0), average (50) to fantastic (100). | Throughout study completion:120 min after consumption of chocolate bar |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia Okanagan | Kelowna | British Columbia | V1V 3G1 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Dark Chocolate Then Ross Dark Chocolate | Start crossover with a standard dark chocolate bar and then a a dark chocolate bar sweetened with stevia, erythritol, and inulin. |
| FG001 | Ross Dark Chocolate Then Conventional Dark Chocolate | Start with a dark chocolate bar sweetened with stevia, erythritol, and inulin and then a conventional dark chocolate. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants with type 1 and type 2 diabetes included for 2 crossover conditions: Ross chocolate and then Conventional chocolate or Conventional chocolate and then Ross chocolate.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants with type 1 and type 2 diabetes completed this crossover study consuming either a conventional dark chocolate and then Ross dark chocolate OR Ross dark chocolate and then conventional dark chocolate. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | People with Type 1 and Type 2 diabetes | Posted | Mean | Standard Error | mM x 120 minutes | 0 and 120 min after consumption of chocolate bar |
|
Duration of intervention period with an average of 2 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional Dark Chocolate and Then Ross Dark Chocolate | Participants consuming a conventional dark chocolate and then Ross dark chocolate. |
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Limitations include small number of subjects recruited and analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jonathan Little | University of British Columbia | 2508786893 | jonathan.little@ubc.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 19, 2020 | Mar 3, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
Highest blood glucose value above fasting baseline after consumption of the chocolate bar
| Throughout study completion: 0-120 minutes after consumption of chocolate bar |
| Blood Glucose | 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. | 0 and 120 minutes |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body mass | Mean | Standard Deviation | kg |
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| Body mass index | Mean | Standard Deviation | kg/m2 |
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| HbA1c | Mean | Standard Deviation | % |
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| Secondary | Peak Blood Glucose Concentration | Highest blood glucose value measured after consumption of the chocolate bar | Posted | Mean | Standard Deviation | mmol/L | 0 and 120 minutes after consumption of chocolate bar |
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| Secondary | Peak Blood Glucose Concentration Above Baseline | Highest blood glucose value above fasting baseline after consumption of the chocolate bar | Posted | Mean | Standard Deviation | mmol/L | Throughout study completion: 0-120 minutes after consumption of chocolate bar |
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| Secondary | Blood Glucose | 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. | Posted | Mean | Standard Deviation | mmol x 120min | 0 and 120 minutes |
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| Other Pre-specified | Taste Questionnaire - 0 to 100 Point Scale | Self-reported taste of chocolate bars will be assessed by questionnaire with ratings from awful (0), average (50) to fantastic (100). | Posted | Mean | Standard Deviation | score on a scale | Throughout study completion:120 min after consumption of chocolate bar |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Ross Dark Chocolate and Then Conventional Dark Chocolate | Participants consuming Ross dark chocolate and then conventional dark chocolate. | 0 | 13 | 0 | 13 | 0 | 13 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |