Trial Outcomes & Findings for Dark Chocolate and Glucose Levels in Diabetes (NCT NCT04847999)

Last Updated: 2025-02-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

0 and 120 min after consumption of chocolate bar

Results posted on

2025-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	6	7
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Dark Chocolate and Glucose Levels in Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=13 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	54.1 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants
Region of Enrollment Canada	13 participants n=5 Participants
Body mass	84.9 kg STANDARD_DEVIATION 23.3 • n=5 Participants
Body mass index	29.0 kg/m2 STANDARD_DEVIATION 5.6 • n=5 Participants
HbA1c	7.3 % STANDARD_DEVIATION 0.5 • n=5 Participants

PRIMARY outcome

Timeframe: 0 and 120 min after consumption of chocolate bar

Population: People with Type 1 and Type 2 diabetes

Outcome measures

Outcome measures
Measure	Dark Chocolate n=13 Participants Conventional Dark chocolate	Ross Dark Chocolate n=13 Participants sugar-free dark chocolate
Blood Glucose Incremental Area Under the Curve	240.5 mM x 120 minutes Standard Error 55.81	83.81 mM x 120 minutes Standard Error 46.18

SECONDARY outcome

Timeframe: 0 and 120 minutes after consumption of chocolate bar

Highest blood glucose value measured after consumption of the chocolate bar

Outcome measures

Outcome measures
Measure	Dark Chocolate n=13 Participants Conventional Dark chocolate	Ross Dark Chocolate n=13 Participants sugar-free dark chocolate
Peak Blood Glucose Concentration	10.6 mmol/L Standard Deviation 2.9	11.9 mmol/L Standard Deviation 4.1

SECONDARY outcome

Timeframe: Throughout study completion: 0-120 minutes after consumption of chocolate bar

Highest blood glucose value above fasting baseline after consumption of the chocolate bar

Outcome measures

Outcome measures
Measure	Dark Chocolate n=13 Participants Conventional Dark chocolate	Ross Dark Chocolate n=13 Participants sugar-free dark chocolate
Peak Blood Glucose Concentration Above Baseline	2.2 mmol/L Standard Deviation 2.2	3.5 mmol/L Standard Deviation 2.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Dark Chocolate n=13 Participants Conventional Dark chocolate	Ross Dark Chocolate n=13 Participants sugar-free dark chocolate
Blood Glucose	1090.8 mmol x 120min Standard Deviation 257.7	1247.5 mmol x 120min Standard Deviation 390.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Dark Chocolate n=13 Participants Conventional Dark chocolate	Ross Dark Chocolate n=13 Participants sugar-free dark chocolate
Taste Questionnaire - 0 to 100 Point Scale	51.6 score on a scale Standard Deviation 22	66 score on a scale Standard Deviation 18.5

Adverse Events

Conventional Dark Chocolate and Then Ross Dark Chocolate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ross Dark Chocolate and Then Conventional Dark Chocolate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Jonathan Little

University of British Columbia

Phone: 2508786893

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place