Type 2 DiabetesNCT04847999
Dark Chocolate and Glucose Levels in Diabetes
A study testing Dark chocolate in people with Type 2 Diabetes and Type 1 Diabetes, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Type 1 Diabetes
- What is being tested?
- Dark chocolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 20 Nov 2020to 4 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia Okanagan
Kelowna, British Columbia, V1V 3G1
About this study
Official title: Impact of Dark Chocolate Consumption on Glucose Levels of People With 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.
Read the 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.
- Conditions
- Type 2 Diabetes, Type 1 Diabetes
- Being tested
- Dark chocolate
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dark chocolateDietary supplement
Dark chocolate
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Dark chocolate |
| 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. Receives: Dietary Supplement: Dark chocolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 and 120 min after consumption of chocolate bar
Secondary outcomes (3)
Peak Blood Glucose Concentration
Highest blood glucose value measured after consumption of the chocolate bar
Measured: 0 and 120 minutes after consumption of chocolate bar
Peak Blood Glucose Concentration Above Baseline
Highest blood glucose value above fasting baseline after consumption of the chocolate bar
Measured: 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.
Measured: 0 and 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start20 Nov 2020
- Primary completion4 May 2021
- Study completion4 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Little, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847999
- Sponsor's protocol ID
- H20-02122
- Status last verified
- Feb 2025
- First submitted
- 5 Jan 2021
- Last updated
- 27 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dark Chocolate Consumption on Glucose Levels of People With Diabetes
- ClinicalTrials.gov ID
- NCT04847999
- Acronym / sponsor ID
- H20-02122
- Conditions
- Type 2 Diabetes, Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Posted 27 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Dark Chocolate then Ross Dark Chocolate | Experimental | Dietary Supplement: Dark chocolateA Conventional dark chocolate bar will be consumed and after a 1-week washout period, Ross Dark chocolate will be consumed. |
| Ross Dark Chocolate and then Conventional chocolate | Experimental | Dietary Supplement: Dark chocolateA 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dark chocolateDark chocolate | Dietary supplement | Conventional Dark Chocolate then Ross Dark Chocolate, Ross Dark Chocolate and then Conventional chocolate |
Primary outcome
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.
3 secondary outcomes
Peak Blood Glucose Concentration
Time frame: 0 and 120 minutes after consumption of chocolate bar
Peak Blood Glucose Concentration Above Baseline
Time frame: Throughout study completion: 0-120 minutes after consumption of chocolate bar
Blood Glucose
Time frame: 0 and 120 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dark chocolate in people with Type 2 Diabetes and Type 1 Diabetes, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose Incremental Area Under the Curve (time frame: 0 and 120 min after consumption of chocolate bar). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.