Type 1 Diabetes, Type 2 Diabetes
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTDark chocolate
Dark chocolate
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Glucose Incremental Area Under the Curve | 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
| Measure | Time frame | Description |
|---|---|---|
| Peak Blood Glucose Concentration | 0 and 120 minutes after consumption of chocolate bar | Highest blood glucose value measured after consumption of the chocolate bar |
| Peak Blood Glucose Concentration Above Baseline | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Taste Questionnaire - 0 to 100 Point Scale | 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). |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 54.1 years STANDARD_DEVIATION 8.6 |
| Body mass | 84.9 kg STANDARD_DEVIATION 23.3 |
| Body mass index | 29.0 kg/m2 STANDARD_DEVIATION 5.6 |
| HbA1c | 7.3 % STANDARD_DEVIATION 0.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Canada | 13 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
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.
Time frame: 0 and 120 min after consumption of chocolate bar
Population: People with Type 1 and Type 2 diabetes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dark Chocolate | Blood Glucose Incremental Area Under the Curve | 240.5 mM x 120 minutes | Standard Error 55.81 |
| Ross Dark Chocolate | Blood Glucose Incremental Area Under the Curve | 83.81 mM x 120 minutes | Standard Error 46.18 |
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.
Time frame: 0 and 120 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dark Chocolate | Blood Glucose | 1090.8 mmol x 120min | Standard Deviation 257.7 |
| Ross Dark Chocolate | Blood Glucose | 1247.5 mmol x 120min | Standard Deviation 390.1 |
Secondary
Peak Blood Glucose Concentration
Highest blood glucose value measured after consumption of the chocolate bar
Time frame: 0 and 120 minutes after consumption of chocolate bar
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dark Chocolate | Peak Blood Glucose Concentration | 10.6 mmol/L | Standard Deviation 2.9 |
| Ross Dark Chocolate | Peak Blood Glucose Concentration | 11.9 mmol/L | Standard Deviation 4.1 |
Secondary
Peak Blood Glucose Concentration Above Baseline
Highest blood glucose value above fasting baseline after consumption of the chocolate bar
Time frame: Throughout study completion: 0-120 minutes after consumption of chocolate bar
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dark Chocolate | Peak Blood Glucose Concentration Above Baseline | 2.2 mmol/L | Standard Deviation 2.2 |
| Ross Dark Chocolate | Peak Blood Glucose Concentration Above Baseline | 3.5 mmol/L | Standard Deviation 2.9 |
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).
Time frame: Throughout study completion:120 min after consumption of chocolate bar
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dark Chocolate | Taste Questionnaire - 0 to 100 Point Scale | 51.6 score on a scale | Standard Deviation 22 |
| Ross Dark Chocolate | Taste Questionnaire - 0 to 100 Point Scale | 66 score on a scale | Standard Deviation 18.5 |