Trial Outcomes & Findings for Effect of Cocoa Supplementation Peripheral and Autonomic Diabetic Neuropathy (NCT NCT05247034)
NCT ID: NCT05247034
Last Updated: 2025-05-01
Results Overview
It is a system of clinical evaluations carried out by the researcher to identify peripheral neuropathy, assigning a score to symptomatology, reflexes and sensory tests. For the purposes of this study, the total score, i.e., the sum of all units on the scale, is reported. The minimum score that can be obtained is 0 points, while the maximum is 19 points. This means that the higher the score, the greater the severity (no grades were established based on the severity of the neuropathy). For the data represented in the row "Change from baseline at Week 12", it is the delta of the final measurement vs. the initial measurement, that is, the final measurement minus the baseline measurement.
COMPLETED
NA
39 participants
At baseline and after 12 weeks
2025-05-01
Participant Flow
Participant milestones
| Measure |
Intervention Group
Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.
Cocoa: Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
|
Control Group
Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.
Placebo: Each capsule contains 500 mg of methylcellulose
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Intervention Group
Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.
Cocoa: Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
|
Control Group
Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.
Placebo: Each capsule contains 500 mg of methylcellulose
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Organizational problems when attending appointments
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Group
n=20 Participants
Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.
Cocoa: Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
|
Control Group
n=19 Participants
Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.
Placebo: Each capsule contains 500 mg of methylcellulose
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 8.67 • n=20 Participants
|
53.7 years
STANDARD_DEVIATION 6.34 • n=19 Participants
|
53.7 years
STANDARD_DEVIATION 7.52 • n=39 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=20 Participants
|
12 Participants
n=19 Participants
|
22 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
7 Participants
n=19 Participants
|
17 Participants
n=39 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Mexico
|
20 participants
n=20 Participants
|
19 participants
n=19 Participants
|
39 participants
n=39 Participants
|
|
Toronto Clinical Scoring System
|
9.31 units on a scale
STANDARD_DEVIATION 3.98 • n=20 Participants
|
6.89 units on a scale
STANDARD_DEVIATION 3.47 • n=19 Participants
|
8.10 units on a scale
STANDARD_DEVIATION 3.88 • n=39 Participants
|
PRIMARY outcome
Timeframe: At baseline and after 12 weeksPopulation: We could not obtain the Toronto Clinical Scoring System from one subject in the intervention group. Intention-to-treat analysis was performed.
It is a system of clinical evaluations carried out by the researcher to identify peripheral neuropathy, assigning a score to symptomatology, reflexes and sensory tests. For the purposes of this study, the total score, i.e., the sum of all units on the scale, is reported. The minimum score that can be obtained is 0 points, while the maximum is 19 points. This means that the higher the score, the greater the severity (no grades were established based on the severity of the neuropathy). For the data represented in the row "Change from baseline at Week 12", it is the delta of the final measurement vs. the initial measurement, that is, the final measurement minus the baseline measurement.
Outcome measures
| Measure |
Intervention Group
n=19 Participants
Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.
Cocoa: Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
|
Control Group
n=19 Participants
Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.
Placebo: Each capsule contains 500 mg of methylcellulose
|
|---|---|---|
|
Toronto Clinical Scoring System (TCSS)
Change from baseline at Week 12
|
-2.63 Score on a scale
Standard Deviation 2.24
|
-1.84 Score on a scale
Standard Deviation 2.77
|
|
Toronto Clinical Scoring System (TCSS)
Baseline total score
|
9.31 Score on a scale
Standard Deviation 3.98
|
6.89 Score on a scale
Standard Deviation 3.47
|
|
Toronto Clinical Scoring System (TCSS)
Final total score
|
6.68 Score on a scale
Standard Deviation 4.41
|
5.05 Score on a scale
Standard Deviation 2.91
|
SECONDARY outcome
Timeframe: At baseline and after 12 weeksPopulation: H reflex was found only in 8 subjects of the intervention group and in 10 subjects of the control group.
Rate-dependent depression (RDD) is a measure of change in amplitude of the Hoffman (H) reflex over consecutive stimulations. Rate-dependent depression is impaired after disinhibition of spinal sensory processing caused by spinal cord injury. For the purposes of this study, the ratio of the amplitude of the pulses Hn/H1 ≥ 0.5 for stimulation frequencies 1, 5 and 10 Hz, was considered as an indicator of dysfunction in somatosensory processing. In healthy subjects, the ratio of the amplitude of the pulses Hn/H1 is expected to be \<0.5. Each subject received 5 pulses for each stimulation frequency, and the average for each subject was determined. The group average was then obtained for each stimulation frequency (1, 5, and 10 Hz). For the data represented in the row "Change from baseline at Week 12", it is the delta of the final measurement vs. the initial measurement, that is, the final measurement minus the baseline measurement.
Outcome measures
| Measure |
Intervention Group
n=8 Participants
Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.
Cocoa: Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
|
Control Group
n=10 Participants
Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.
Placebo: Each capsule contains 500 mg of methylcellulose
|
|---|---|---|
|
Rate-dependent Depression of the H-reflex
Change from baseline at Week 12 for 1 Hz
|
0.13 Ratio
Standard Deviation 0.36
|
0.01 Ratio
Standard Deviation 0.28
|
|
Rate-dependent Depression of the H-reflex
Baseline 1 Hz mean
|
0.87 Ratio
Standard Deviation 0.35
|
0.88 Ratio
Standard Deviation 0.33
|
|
Rate-dependent Depression of the H-reflex
Final 1 Hz mean
|
0.99 Ratio
Standard Deviation 0.28
|
0.89 Ratio
Standard Deviation 0.16
|
|
Rate-dependent Depression of the H-reflex
Change from baseline at Week 12 for 5 Hz
|
-0.02 Ratio
Standard Deviation 0.51
|
-0.03 Ratio
Standard Deviation 0.30
|
|
Rate-dependent Depression of the H-reflex
Baseline 5 Hz mean
|
0.91 Ratio
Standard Deviation 0.67
|
0.71 Ratio
Standard Deviation 0.38
|
|
Rate-dependent Depression of the H-reflex
Final 5 Hz mean
|
0.89 Ratio
Standard Deviation 0.21
|
0.65 Ratio
Standard Deviation 0.27
|
|
Rate-dependent Depression of the H-reflex
Change from baseline at Week 12 for 10 Hz
|
0.13 Ratio
Standard Deviation 0.28
|
-0.06 Ratio
Standard Deviation 0.20
|
|
Rate-dependent Depression of the H-reflex
Baseline 10 Hz mean
|
0.56 Ratio
Standard Deviation 0.47
|
0.71 Ratio
Standard Deviation 0.42
|
|
Rate-dependent Depression of the H-reflex
Final 10 Hz mean
|
0.72 Ratio
Standard Deviation 0.25
|
0.62 Ratio
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: At baseline, after 4, 8 and 12 weeksPopulation: Intention-to-treat analysis was performed
The questionnaire includes 4 questions that refer to gastrointestinal symptoms. This questions are measured in a scale from 1 (better health status) to 5 (worse health status) and it is related to gastrointestinal autonomic diabetic neuropathy. Final score: Minimum is 4 points (better health status) and maximum is 19 points (worse health status). For the data represented in the row "Change from baseline at Week 12", it is the delta of the final measurement vs. the initial measurement, that is, the final measurement minus the baseline measurement.
Outcome measures
| Measure |
Intervention Group
n=20 Participants
Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.
Cocoa: Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
|
Control Group
n=19 Participants
Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.
Placebo: Each capsule contains 500 mg of methylcellulose
|
|---|---|---|
|
BEST Questionnaire
Change from baseline at Week 12
|
-1.45 score on a scale
Standard Deviation 2.62
|
-2.21 score on a scale
Standard Deviation 2.59
|
|
BEST Questionnaire
Baseline total score
|
9.35 score on a scale
Standard Deviation 2.75
|
9.05 score on a scale
Standard Deviation 2.77
|
|
BEST Questionnaire
Final total score
|
7.9 score on a scale
Standard Deviation 2.67
|
6.84 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: At baseline and 12 weeksPopulation: Results presented are represented as percentage of subjects who had alteration in their bristol scale
It is composed of categories that include an image and an explanation, ranging from 1 to 7, being 1 separate hard pieces, which pass with difficulty and 7 watery stools. It is related to gastrointestinal autonomic diabetic neuropathy. The reported outcomes are the percentage of participants who had altered bristol stool form scale, that is, participants who were in categories 1, 2, 5, 6 and 7.
Outcome measures
| Measure |
Intervention Group
n=20 Participants
Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.
Cocoa: Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
|
Control Group
n=19 Participants
Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.
Placebo: Each capsule contains 500 mg of methylcellulose
|
|---|---|---|
|
Bristol Stool Form Scale
Baseline altered bristol stool scale form
|
40 percentage of participants
|
57.8 percentage of participants
|
|
Bristol Stool Form Scale
Final altered bristol stool scale form
|
30 percentage of participants
|
52.6 percentage of participants
|
SECONDARY outcome
Timeframe: At baseline, after 4, 8 and 12 weeksPopulation: We could not obtain the weight measure from one participant of the intervention group. Intention-to-treat analysis was performed.
Weight of an individual in kg determined by the scale. The measurement is done without shoes and with as little clothing as possible. The subject must be placed in the center and remain still during the measurement. For the data represented in the row "Change from baseline at Week 12", it is the delta of the final measurement vs. the initial measurement, that is, the final measurement minus the baseline measurement.
Outcome measures
| Measure |
Intervention Group
n=19 Participants
Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.
Cocoa: Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
|
Control Group
n=19 Participants
Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.
Placebo: Each capsule contains 500 mg of methylcellulose
|
|---|---|---|
|
Weight
Change from baseline at Week 12
|
0.38 kg
Standard Deviation 2.72
|
-0.42 kg
Standard Deviation 2.18
|
|
Weight
Baseline
|
73.5 kg
Standard Deviation 14.1
|
82.8 kg
Standard Deviation 13.8
|
|
Weight
Week 4
|
74.4 kg
Standard Deviation 14.8
|
82.5 kg
Standard Deviation 13.9
|
|
Weight
Week 8
|
74.1 kg
Standard Deviation 14.7
|
83 kg
Standard Deviation 13.7
|
|
Weight
Final
|
73.8 kg
Standard Deviation 14.6
|
82.4 kg
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: At baseline, after 4, 8 and 12 weeksPopulation: Intention-to-treat analysis was performed.
Waist circumference in cm: The measuring tape is placed in a horizontal plane around the waist, taking the midaxillary line as a reference, locating the midpoint between the lower costal margin and the highest lateral border of the iliac crest. For the data represented in the row "Change from baseline at Week 12", it is the delta of the final measurement vs. the initial measurement, that is, the final measurement minus the baseline measurement.
Outcome measures
| Measure |
Intervention Group
n=20 Participants
Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.
Cocoa: Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
|
Control Group
n=19 Participants
Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.
Placebo: Each capsule contains 500 mg of methylcellulose
|
|---|---|---|
|
Waist Circumference
Change from baseline at Week 12
|
-0.8 cm
Standard Deviation 2.19
|
-1.38 cm
Standard Deviation 4.11
|
|
Waist Circumference
Baseline
|
96.7 cm
Standard Deviation 7.49
|
103 cm
Standard Deviation 13.1
|
|
Waist Circumference
Week 4
|
96.5 cm
Standard Deviation 7.08
|
103 cm
Standard Deviation 11.7
|
|
Waist Circumference
Week 8
|
96 cm
Standard Deviation 7.33
|
103 cm
Standard Deviation 12
|
|
Waist Circumference
Final
|
95.9 cm
Standard Deviation 7.28
|
102 cm
Standard Deviation 12
|
SECONDARY outcome
Timeframe: At baseline, after 4, 8 and 12 weeksPopulation: We could not obtain the height from 1 subject from the cocoa group. Intention-to-treat analysis was performed.
It is obtained by dividing the waist circumference in cm by the height in cm, with a result of ≥ 0.5 indicating an increased risk for cardiometabolic disease. For the data represented in the row "Change from baseline at Week 12", it is the delta of the final measurement vs. the initial measurement, that is, the final measurement minus the baseline measurement.
Outcome measures
| Measure |
Intervention Group
n=19 Participants
Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.
Cocoa: Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
|
Control Group
n=19 Participants
Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.
Placebo: Each capsule contains 500 mg of methylcellulose
|
|---|---|---|
|
Waist-to-Height Ratio
Change from baseline at Week 12
|
-0.00 Ratio
Standard Deviation 0.01
|
-0.00 Ratio
Standard Deviation 0.02
|
|
Waist-to-Height Ratio
Baseline
|
0.6 Ratio
Standard Deviation 0.04
|
0.64 Ratio
Standard Deviation 0.09
|
|
Waist-to-Height Ratio
Week 4
|
0.6 Ratio
Standard Deviation 0.04
|
0.64 Ratio
Standard Deviation 0.08
|
|
Waist-to-Height Ratio
Week 8
|
0.6 Ratio
Standard Deviation 0.04
|
0.64 Ratio
Standard Deviation 0.09
|
|
Waist-to-Height Ratio
Final
|
0.6 Ratio
Standard Deviation 0.04
|
0.63 Ratio
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: At baseline, after 4, 8 and 12 weeksPopulation: Abdominal circumference couldn't be obtained from 2 subjects (1 from cocoa group and 1 from control group) Intention-to-treat analysis was performed.
Abdominal circumference in cm: The top of the hip bone and the top of the right iliac crest are located and the measuring tape is placed horizontally around the abdomen, at the level of the iliac crest, at the end of a normal expiration. For the data represented in the row "Change from baseline at Week 12", it is the delta of the final measurement vs. the initial measurement, that is, the final measurement minus the baseline measurement.
Outcome measures
| Measure |
Intervention Group
n=19 Participants
Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.
Cocoa: Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
|
Control Group
n=18 Participants
Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.
Placebo: Each capsule contains 500 mg of methylcellulose
|
|---|---|---|
|
Abdominal Circumference
Change from baseline at Week 12
|
-0.75 cm
Standard Deviation 2.45
|
-1.02 cm
Standard Deviation 3.07
|
|
Abdominal Circumference
Baseline
|
100 cm
Standard Deviation 9.31
|
106 cm
Standard Deviation 11.4
|
|
Abdominal Circumference
Week 4
|
100 cm
Standard Deviation 9.26
|
105 cm
Standard Deviation 11.7
|
|
Abdominal Circumference
Week 8
|
99.9 cm
Standard Deviation 9.27
|
105 cm
Standard Deviation 12
|
|
Abdominal Circumference
Final
|
99.4 cm
Standard Deviation 9.01
|
104 cm
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: At baseline, after 4, 8 and 12 weeksPopulation: Intention-to-treat analysis was performed.
A sphygmomanometer is used to obtain blood pressure with the technique specified in the Clinical Practice Guidelines for the diagnosis and treatment of arterial hypertension at the first level of care, it is measured in mmHg. For the data represented in the row "Change from baseline at Week 12", it is the delta of the final measurement vs. the initial measurement, that is, the final measurement minus the baseline measurement.
Outcome measures
| Measure |
Intervention Group
n=20 Participants
Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.
Cocoa: Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
|
Control Group
n=19 Participants
Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.
Placebo: Each capsule contains 500 mg of methylcellulose
|
|---|---|---|
|
Systolic Blood Pressure
Change from baseline at Week 12
|
-3.7 mmHg
Standard Deviation 11
|
-3.78 mmHg
Standard Deviation 14.8
|
|
Systolic Blood Pressure
Baseline
|
126 mmHg
Standard Deviation 14.6
|
127 mmHg
Standard Deviation 15.5
|
|
Systolic Blood Pressure
Week 4
|
125 mmHg
Standard Deviation 13.5
|
130 mmHg
Standard Deviation 17.2
|
|
Systolic Blood Pressure
Week 8
|
122 mmHg
Standard Deviation 12.2
|
125 mmHg
Standard Deviation 9.7
|
|
Systolic Blood Pressure
Final
|
122 mmHg
Standard Deviation 14.2
|
124 mmHg
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: At baseline, after 4, 8 and 12 weeksPopulation: Intention-to-treat analysis was performed.
A sphygmomanometer is used to obtain blood pressure with the technique specified in the Clinical Practice Guidelines for the diagnosis and treatment of arterial hypertension at the first level of care, it is measured in mmHg. For the data represented in the row "Change from baseline at Week 12", it is the delta of the final measurement vs. the initial measurement, that is, the final measurement minus the baseline measurement.
Outcome measures
| Measure |
Intervention Group
n=20 Participants
Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.
Cocoa: Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
|
Control Group
n=19 Participants
Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.
Placebo: Each capsule contains 500 mg of methylcellulose
|
|---|---|---|
|
Diastolic Blood Pressure
Change from baseline at Week 12
|
-2.32 mmHg
Standard Deviation 7.57
|
-2.36 mmHg
Standard Deviation 10.1
|
|
Diastolic Blood Pressure
Baseline
|
79.9 mmHg
Standard Deviation 8.23
|
78.1 mmHg
Standard Deviation 7.98
|
|
Diastolic Blood Pressure
Week 4
|
78.7 mmHg
Standard Deviation 8.78
|
79 mmHg
Standard Deviation 7.77
|
|
Diastolic Blood Pressure
Week 8
|
79.8 mmHg
Standard Deviation 9.1
|
76.6 mmHg
Standard Deviation 7.13
|
|
Diastolic Blood Pressure
Final
|
77.6 mmHg
Standard Deviation 9.96
|
75.7 mmHg
Standard Deviation 7.97
|
SECONDARY outcome
Timeframe: At baseline and after 12 weeksPopulation: Intention-to-treat analysis was performed
Blood glucose concentration and is measured as mg/dL. For the data represented in the row "Change from baseline at Week 12", it is the delta of the final measurement vs. the initial measurement, that is, the final measurement minus the baseline measurement.
Outcome measures
| Measure |
Intervention Group
n=20 Participants
Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.
Cocoa: Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
|
Control Group
n=19 Participants
Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.
Placebo: Each capsule contains 500 mg of methylcellulose
|
|---|---|---|
|
Glucose
Change from baseline at Week 12
|
-17 mg/dL
Standard Deviation 42.8
|
-38.1 mg/dL
Standard Deviation 55.9
|
|
Glucose
Baseline mg/dL
|
169 mg/dL
Standard Deviation 62.6
|
195 mg/dL
Standard Deviation 85.7
|
|
Glucose
Final mg/dL
|
152 mg/dL
Standard Deviation 58.4
|
157 mg/dL
Standard Deviation 63.6
|
SECONDARY outcome
Timeframe: At baseline and after 12 weeksPopulation: Intention-to-treat analysis was performed
Value of the fraction of hemoglobin that has glucose attached and is reported in percentage (%). For the data represented in the row "Change from baseline at Week 12", it is the delta of the final measurement vs. the initial measurement, that is, the final measurement minus the baseline measurement.
Outcome measures
| Measure |
Intervention Group
n=20 Participants
Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.
Cocoa: Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
|
Control Group
n=19 Participants
Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.
Placebo: Each capsule contains 500 mg of methylcellulose
|
|---|---|---|
|
Glycated Hemoglobin A1c
Change from baseline at Week 12
|
-0.17 percentage of glycated hemoglobin
Standard Deviation 1.09
|
-0.27 percentage of glycated hemoglobin
Standard Deviation 0.60
|
|
Glycated Hemoglobin A1c
Baseline % of glycated hemoglobin
|
7.82 percentage of glycated hemoglobin
Standard Deviation 1.9
|
8.28 percentage of glycated hemoglobin
Standard Deviation 2.02
|
|
Glycated Hemoglobin A1c
Final % of glycated hemoglobin
|
7.72 percentage of glycated hemoglobin
Standard Deviation 1.5
|
8 percentage of glycated hemoglobin
Standard Deviation 2.04
|
SECONDARY outcome
Timeframe: At baseline and after 12 weeksPopulation: Intention-to-treat analysis was performed
Blood triglycerides concentration and is measured as mg/dL. For the data represented in the row "Change from baseline at Week 12", it is the delta of the final measurement vs. the initial measurement, that is, the final measurement minus the baseline measurement.
Outcome measures
| Measure |
Intervention Group
n=20 Participants
Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.
Cocoa: Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
|
Control Group
n=19 Participants
Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.
Placebo: Each capsule contains 500 mg of methylcellulose
|
|---|---|---|
|
Triglycerides
Change from baseline at Week 12
|
-4.96 mg/dL
Standard Deviation 60.2
|
-13.9 mg/dL
Standard Deviation 44.6
|
|
Triglycerides
Baseline mg/dL
|
182 mg/dL
Standard Deviation 81.4
|
179 mg/dL
Standard Deviation 58.8
|
|
Triglycerides
Final mg/dL
|
177 mg/dL
Standard Deviation 78.8
|
165 mg/dL
Standard Deviation 52.1
|
SECONDARY outcome
Timeframe: At baseline and after 12 weeksPopulation: Intention-to-treat analysis was performed
Blood high-density lipoprotein cholesterol concentration and is measured as mg/dL. For the data represented in the row "Change from baseline at Week 12", it is the delta of the final measurement vs. the initial measurement, that is, the final measurement minus the baseline measurement.
Outcome measures
| Measure |
Intervention Group
n=20 Participants
Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.
Cocoa: Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
|
Control Group
n=19 Participants
Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.
Placebo: Each capsule contains 500 mg of methylcellulose
|
|---|---|---|
|
High-density Lipoprotein Cholesterol
Change from baseline at Week 12
|
-0.86 mg/dL
Standard Deviation 3.71
|
2.18 mg/dL
Standard Deviation 6.23
|
|
High-density Lipoprotein Cholesterol
Baseline mg/dL
|
37.8 mg/dL
Standard Deviation 9.52
|
38.2 mg/dL
Standard Deviation 9.12
|
|
High-density Lipoprotein Cholesterol
Final mg/dL
|
36.9 mg/dL
Standard Deviation 7.5
|
40.4 mg/dL
Standard Deviation 6.26
|
SECONDARY outcome
Timeframe: At baseline and after 12 weeksPopulation: Intention-to-treat analysis was performed
It is obtained after dividing the serum concentration of triglycerides in mg/dL by the serum concentration of HDL in mg/dL. It does not have units. For the data represented in the row "Change from baseline at Week 12", it is the delta of the final measurement vs. the initial measurement, that is, the final measurement minus the baseline measurement.
Outcome measures
| Measure |
Intervention Group
n=20 Participants
Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.
Cocoa: Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
|
Control Group
n=19 Participants
Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.
Placebo: Each capsule contains 500 mg of methylcellulose
|
|---|---|---|
|
Triglycerides/HDL Ratio
Change from baseline at Week 12
|
-0.02 Ratio
Standard Deviation 1.98
|
-0.74 Ratio
Standard Deviation 2.13
|
|
Triglycerides/HDL Ratio
Baseline
|
5.12 Ratio
Standard Deviation 2.84
|
4.99 Ratio
Standard Deviation 2.13
|
|
Triglycerides/HDL Ratio
Final
|
5.1 Ratio
Standard Deviation 2.9
|
4.25 Ratio
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: At baseline and after 12 weeksPopulation: Intention-to-treat analysis was performed
Blood low-density lipoprotein cholesterol concentration and is measured as mg/dL. For the data represented in the row "Change from baseline at Week 12", it is the delta of the final measurement vs. the initial measurement, that is, the final measurement minus the baseline measurement.
Outcome measures
| Measure |
Intervention Group
n=20 Participants
Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.
Cocoa: Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
|
Control Group
n=19 Participants
Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.
Placebo: Each capsule contains 500 mg of methylcellulose
|
|---|---|---|
|
Low-density Lipoprotein Cholesterol
Baseline mg/dL
|
112 mg/dL
Standard Deviation 31.8
|
108 mg/dL
Standard Deviation 31.3
|
|
Low-density Lipoprotein Cholesterol
Final mg/dL
|
121 mg/dL
Standard Deviation 35.2
|
112 mg/dL
Standard Deviation 34.7
|
|
Low-density Lipoprotein Cholesterol
Change from baseline at Week 12
|
8.88 mg/dL
Standard Deviation 22.1
|
4.15 mg/dL
Standard Deviation 18.1
|
SECONDARY outcome
Timeframe: At baseline and after 12 weeksPopulation: Intention-to-treat analysis was performed.
It is obtained by dividing the serum concentration of the absolute number of neutrophils by the serum concentration of the absolute number of lymphocytes. Without unit. For the data represented in the row "Change from baseline at Week 12", it is the delta of the final measurement vs. the initial measurement, that is, the final measurement minus the baseline measurement.
Outcome measures
| Measure |
Intervention Group
n=20 Participants
Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.
Cocoa: Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
|
Control Group
n=19 Participants
Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.
Placebo: Each capsule contains 500 mg of methylcellulose
|
|---|---|---|
|
Neutrophil/Lymphocyte Ratio
Baseline
|
1.96 Ratio
Standard Deviation 0.86
|
1.76 Ratio
Standard Deviation 0.55
|
|
Neutrophil/Lymphocyte Ratio
Change from baseline at Week 12
|
-0.09 Ratio
Standard Deviation 0.77
|
0.15 Ratio
Standard Deviation 0.45
|
|
Neutrophil/Lymphocyte Ratio
Final
|
1.87 Ratio
Standard Deviation 1.07
|
1.92 Ratio
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: At baseline and after 12 weeksPopulation: Intention-to-treat analysis was performed
It is a self-administered instrument that allows patients to describe how their QOL was affected during the previous month in five domains: energy and mobility (15 questions), diabetes control (12 questions), anxiety and worry (4 questions), social impact (5 questions), and sexual behavior (3 questions). Responses are scored on a seven-point scale that ranged from "not affected at all" (score = 1) to "extremely affected" (score = 7). All responses are summed and it is applied a linear transformation to a 0-100 scale. Lower scores indicated a better QOL. For the data represented in the row "Change from baseline at Week 12", it is the delta of the final measurement vs. the initial measurement, that is, the final measurement minus the baseline measurement.
Outcome measures
| Measure |
Intervention Group
n=20 Participants
Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.
Cocoa: Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
|
Control Group
n=19 Participants
Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.
Placebo: Each capsule contains 500 mg of methylcellulose
|
|---|---|---|
|
Diabetes 39 Instrument
Change from baseline at Week 12
|
-9.19 score on a scale
Standard Deviation 11.6
|
-5.26 score on a scale
Standard Deviation 19
|
|
Diabetes 39 Instrument
Baseline total score
|
43.4 score on a scale
Standard Deviation 26.8
|
35.6 score on a scale
Standard Deviation 22.6
|
|
Diabetes 39 Instrument
Final total score
|
34.2 score on a scale
Standard Deviation 25.8
|
30.4 score on a scale
Standard Deviation 24.5
|
Adverse Events
Intervention Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Carlos Alberto Cuéllar Ramos
Universidad Anáhuac México Norte
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place