Diabetic Neuropathies
Conditions
Keywords
Cocoa, Diabetic neuropathy, H-reflex, Cardiometabolic risk factor, Polyphenols, Antioxidants
Brief summary
Type 2 diabetes mellitus is a high incidence disease in Mexico and is associated with the development of chronic degenerative complications such as diabetic neuropathy. The latter manifests itself as a set of disorders that occur as a consequence of a chronic hyperglycemic state that can induce oxidative stress and inflammation, resulting in damage to the autonomic and peripheral nervous system. In Mexico, it has been reported that this complication usually occurs between 29% and 90% of patients with diabetes. Cocoa is a food with a high content of flavonoids, which are phenolic compounds with antioxidant and anti-inflammatory effects. Additionally, its consumption has been associated with a decrease in hyperglycemia and insulin resistance, improvement in mitochondrial function, and, based on the above, an effect on diabetic complications has been suggested; This has been demonstrated in in vivo and in vitro models, but not in the human population. Once the symptoms of diabetic neuropathy have started, palliative treatments are prescribed, and to date there are no pharmacological compounds that have been shown to reverse the consequences of diabetic peripheral and autonomic neuropathy. Additionally, clinical trials of compounds with antioxidant properties have only performed subjective evaluations based on questionnaires on the perception of the improvement of diabetic neuropathy and some biochemical markers or nerve conduction tests, however, the results shown have not been conclusive. This is why a double-blind, randomized controlled clinical trial is proposed, with the objective of evaluating the effect of cocoa supplementation in patients with type 2 diabetes mellitus and peripheral and autonomic diabetic neuropathy on a) the biochemical profile, which includes the evaluation of the glycemic and lipid profile, quantification of pro-inflammatory cytokines and oxidative stress markers; b) the clinical profile through the application of standardized questionnaires, anthropometric measurements and blood pressure, and c) somatosensory processing through the paired pulse H reflex test. The hypothesis of this study is that cocoa supplementation will have a beneficial effect on the biochemical and clinical profile and somatosensory processing of peripheral and autonomic diabetic neuropathy.
Detailed description
Type 2 diabetes mellitus (T2DM) is a high incidence disease in Mexico and is associated with the development of chronic degenerative complications such as diabetic neuropathy. The latter manifests itself as a set of disorders that occur as a consequence of a chronic hyperglycemic state that can induce oxidative stress and inflammation, resulting in damage to the autonomic and peripheral nervous system. In Mexico, it has been reported that this complication usually occurs between 29% and 90% of patients with diabetes. Cocoa is a food with a high content of flavonoids, which are phenolic compounds with antioxidant and anti-inflammatory effects. Additionally, its consumption has been associated with a decrease in hyperglycemia and insulin resistance, improvement in mitochondrial function, and, based on the above, an effect on diabetic complications has been suggested; This has been demonstrated in in vivo and in vitro models, but not in the human population. Once the symptoms of diabetic neuropathy have started, palliative treatments are prescribed, and to date there are no pharmacological compounds that have been shown to reverse the consequences of diabetic peripheral and autonomic neuropathy. Additionally, clinical trials of compounds with antioxidant properties have only performed subjective evaluations based on questionnaires on the perception of the improvement of diabetic neuropathy and some biochemical markers or nerve conduction tests, however, the results shown have not been conclusive. This is why a double-blind, randomized controlled clinical trial is proposed, with the objective of evaluating the effect of cocoa supplementation in patients with type 2 diabetes mellitus and peripheral and autonomic diabetic neuropathy on a) the biochemical profile, which includes the evaluation of the glycemic and lipid profile, quantification of pro-inflammatory cytokines and oxidative stress markers; b) the clinical profile through the application of standardized questionnaires, anthropometric measurements and blood pressure, and c) somatosensory processing through the paired pulse H reflex test. Hypothesis: The hypothesis of this study is that cocoa supplementation will have a beneficial effect on the biochemical and clinical profile and somatosensory processing of peripheral and autonomic diabetic neuropathy. Statistical analysis: For the evaluation of the intragroup variables, a statistical analysis will be carried out with ANOVA for repeated samples with Tukey's post hoc, or, where appropriate, Friedman with Dunn's post hoc, as well as Student's t for dependent groups, or in its case, with Wilcoxon. The intergroup comparison will be made with Student's T for independent samples, or if applicable, with Mann Whitney's U, considering p \<0.05 as statistical significance and using the statistical software GraphPad Prism version 5. The H reflex test will be performed by electrical stimulation through disposable surface electrodes connected to a constant current bipolar electrical stimulator (Digitimer DS8R). The recording of the electrophysiological signals will be carried out using surface electrodes connected to the signal acquisition and amplification system (LabChart and PowerLab 8/35, ADInstruments). The signals obtained will be sampled at 10 kilohertz (KHz) with a 0.5- 500 Hz band-pass filter. The signals will be stored in a computer for later analysis. The placement of electrodes for stimulation will be carried out as follows: the active electrode (anode) at the level of the Achilles tendon, the positive electrode (cathode) above the inverted v between the calf muscles (gastrocnemius). Subsequently, the reference electrode will be placed at the level of the gastrocnemius heads. It will be stimulated behind the knee where the tibial nerve has its anatomical path. The test will start with an intensity of 0 milliamp (mA) and then pulses will be given every 0.5 millivolts (mV) until the evoked potential (H reflex) is observed in a consistent and clearly identifiable way as a function of latency (35-45 ms). The electrical stimulus consists of the application of 1 square pulse (1 ms duration each pulse) every 10 seconds (10 pulses in total). The maximum intensity of the applied current will be according to the sensitivity and tolerance of the individual in both lower limbs during the tests on the sensory and motor nerves. The applied electrical pulse should not cause a painful sensation, but it can cause a tingling sensation. The test will be suspended if the individual reports pain or does not wish to continue with the research protocol. The H reflex test will be done in two parts. The first part of the protocol consists of determining the stimulus intensity vs. amplitude of motor responses from the appearance of the M wave and the H wave, for which the electric current will be increased in steps of 0.5 µA until the appearance of the waves. For this part, only one electrical pulse (1 ms duration) will be given every 10 seconds. The intensity of electrical current that will be used for the second part of the protocol will be that whose value in the amplitude curve of the H wave-electrical current intensity reaches 60% of the maximum amplitude. This stimulation value guarantees the reproducibility and minimum variability of this wave, which also prevents muscle contraction that contaminates the electrical register. The second part constitutes the paired electrical stimulation test in which two electrical pulses (1 ms in duration) will be produced at different frequencies between the pulses: 0.1, 1, 5 and 10 Hz. The interval between the paired pulses will be 10 s, until completing 10 series. The electrophysiological recordings will be analyzed with the Clampfit 10.0 software. The latency and amplitude of the evoked potentials H1 and H2 will be determined for each electrical pulse and at all stimulation frequencies, taking the stimulus artifact as a reference. Subsequently, the ratio of the amplitude of the paired H2/H1 pulses will be determined to establish the modulation of spinal excitability. A ratio ≥0.6 for any stimulation frequency will be considered as an indicator of dysfunction in somatosensory processing according to Marshall et al.
Interventions
DIETARY_SUPPLEMENTCocoa
Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.
OTHERPlacebo
Each capsule contains 500 mg of methylcellulose
Sponsors
Anahuac University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 40-60 years with a diagnosis of type 2 diabetes mellitus and diabetic neuropathy * Minimum time of diagnosis of T2DM of 5 years * Who have a Michigan Neuropathy Screening Instrument (MNSI) score ≥2 * Male and Female * Have them sign the informed consent letter
Exclusion criteria
* Subjects who modify their pharmacological treatment during the study * Subjects who do not attend one of the intermediate consultations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toronto Clinical Scoring System (TCSS) | At baseline and after 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BEST Questionnaire | At baseline, after 4, 8 and 12 weeks | 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. |
| Bristol Stool Form Scale | At baseline and 12 weeks | 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. |
| Weight | At baseline, after 4, 8 and 12 weeks | 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. |
| Waist Circumference | At baseline, after 4, 8 and 12 weeks | 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. |
| Waist-to-Height Ratio | At baseline, after 4, 8 and 12 weeks | 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. |
| Abdominal Circumference | At baseline, after 4, 8 and 12 weeks | 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. |
| Systolic Blood Pressure | At baseline, after 4, 8 and 12 weeks | 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. |
| Diastolic Blood Pressure | At baseline, after 4, 8 and 12 weeks | 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. |
| Rate-dependent Depression of the H-reflex | At baseline and after 12 weeks | 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. |
| Glycated Hemoglobin A1c | At baseline and after 12 weeks | 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. |
| Triglycerides | At baseline and after 12 weeks | 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. |
| High-density Lipoprotein Cholesterol | At baseline and after 12 weeks | 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. |
| Triglycerides/HDL Ratio | At baseline and after 12 weeks | 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. |
| Low-density Lipoprotein Cholesterol | At baseline and after 12 weeks | 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. |
| Neutrophil/Lymphocyte Ratio | At baseline and after 12 weeks | 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. |
| Diabetes 39 Instrument | At baseline and after 12 weeks | 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. |
| Glucose | At baseline and after 12 weeks | 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. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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 | 19 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Organizational problems when attending appointments | 1 | 0 |
Baseline characteristics
| Characteristic | Intervention Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 53.6 years STANDARD_DEVIATION 8.67 | 53.7 years STANDARD_DEVIATION 7.52 | 53.7 years STANDARD_DEVIATION 6.34 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Mexico | 20 participants | 39 participants | 19 participants |
| Sex: Female, Male Female | 10 Participants | 22 Participants | 12 Participants |
| Sex: Female, Male Male | 10 Participants | 17 Participants | 7 Participants |
| Toronto Clinical Scoring System | 9.31 units on a scale STANDARD_DEVIATION 3.98 | 8.10 units on a scale STANDARD_DEVIATION 3.88 | 6.89 units on a scale STANDARD_DEVIATION 3.47 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 0 / 20 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 |
Outcome results
Primary
Toronto Clinical Scoring System (TCSS)
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.
Time frame: At baseline and after 12 weeks
Population: We could not obtain the Toronto Clinical Scoring System from one subject in the intervention group.~Intention-to-treat analysis was performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Toronto Clinical Scoring System (TCSS) | Baseline total score | 9.31 Score on a scale | Standard Deviation 3.98 |
| Intervention Group | Toronto Clinical Scoring System (TCSS) | Final total score | 6.68 Score on a scale | Standard Deviation 4.41 |
| Intervention Group | Toronto Clinical Scoring System (TCSS) | Change from baseline at Week 12 | -2.63 Score on a scale | Standard Deviation 2.24 |
| Control Group | Toronto Clinical Scoring System (TCSS) | Change from baseline at Week 12 | -1.84 Score on a scale | Standard Deviation 2.77 |
| Control Group | Toronto Clinical Scoring System (TCSS) | Baseline total score | 6.89 Score on a scale | Standard Deviation 3.47 |
| Control Group | Toronto Clinical Scoring System (TCSS) | Final total score | 5.05 Score on a scale | Standard Deviation 2.91 |
Comparison: Comparing row Change from baseline at Week 12p-value: >0.05t-test, 2 sided
p-value: 0.0001Wilcoxon (Mann-Whitney)
p-value: 0.0125Wilcoxon (Mann-Whitney)
Secondary
Abdominal Circumference
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.
Time frame: At baseline, after 4, 8 and 12 weeks
Population: Abdominal circumference couldn't be obtained from 2 subjects (1 from cocoa group and 1 from control group) Intention-to-treat analysis was performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Abdominal Circumference | Change from baseline at Week 12 | -0.75 cm | Standard Deviation 2.45 |
| Intervention Group | Abdominal Circumference | Week 8 | 99.9 cm | Standard Deviation 9.27 |
| Intervention Group | Abdominal Circumference | Week 4 | 100 cm | Standard Deviation 9.26 |
| Intervention Group | Abdominal Circumference | Final | 99.4 cm | Standard Deviation 9.01 |
| Intervention Group | Abdominal Circumference | Baseline | 100 cm | Standard Deviation 9.31 |
| Control Group | Abdominal Circumference | Final | 104 cm | Standard Deviation 12.1 |
| Control Group | Abdominal Circumference | Change from baseline at Week 12 | -1.02 cm | Standard Deviation 3.07 |
| Control Group | Abdominal Circumference | Week 4 | 105 cm | Standard Deviation 11.7 |
| Control Group | Abdominal Circumference | Week 8 | 105 cm | Standard Deviation 12 |
| Control Group | Abdominal Circumference | Baseline | 106 cm | Standard Deviation 11.4 |
Comparison: Comparing row Change from baseline at Week 12p-value: >0.05t-test, 2 sided
p-value: >0.05ANOVA
p-value: >0.05ANOVA
Secondary
BEST Questionnaire
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.
Time frame: At baseline, after 4, 8 and 12 weeks
Population: Intention-to-treat analysis was performed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | BEST Questionnaire | Change from baseline at Week 12 | -1.45 score on a scale | Standard Deviation 2.62 |
| Intervention Group | BEST Questionnaire | Baseline total score | 9.35 score on a scale | Standard Deviation 2.75 |
| Intervention Group | BEST Questionnaire | Final total score | 7.9 score on a scale | Standard Deviation 2.67 |
| Control Group | BEST Questionnaire | Change from baseline at Week 12 | -2.21 score on a scale | Standard Deviation 2.59 |
| Control Group | BEST Questionnaire | Baseline total score | 9.05 score on a scale | Standard Deviation 2.77 |
| Control Group | BEST Questionnaire | Final total score | 6.84 score on a scale | Standard Deviation 2.6 |
Comparison: Comparing row Change from baseline at Week 12p-value: >0.05Wilcoxon (Mann-Whitney)
p-value: 0.042Friedman
p-value: 0.015Friedman
Secondary
Bristol Stool Form 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.
Time frame: At baseline and 12 weeks
Population: Results presented are represented as percentage of subjects who had alteration in their bristol scale
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention Group | Bristol Stool Form Scale | Baseline altered bristol stool scale form | 40 percentage of participants |
| Intervention Group | Bristol Stool Form Scale | Final altered bristol stool scale form | 30 percentage of participants |
| Control Group | Bristol Stool Form Scale | Baseline altered bristol stool scale form | 57.8 percentage of participants |
| Control Group | Bristol Stool Form Scale | Final altered bristol stool scale form | 52.6 percentage of participants |
p-value: >0.05Z Test
p-value: >0.05Z Test
p-value: >0.05Z Test
Secondary
Diabetes 39 Instrument
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.
Time frame: At baseline and after 12 weeks
Population: Intention-to-treat analysis was performed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Diabetes 39 Instrument | Change from baseline at Week 12 | -9.19 score on a scale | Standard Deviation 11.6 |
| Intervention Group | Diabetes 39 Instrument | Baseline total score | 43.4 score on a scale | Standard Deviation 26.8 |
| Intervention Group | Diabetes 39 Instrument | Final total score | 34.2 score on a scale | Standard Deviation 25.8 |
| Control Group | Diabetes 39 Instrument | Change from baseline at Week 12 | -5.26 score on a scale | Standard Deviation 19 |
| Control Group | Diabetes 39 Instrument | Baseline total score | 35.6 score on a scale | Standard Deviation 22.6 |
| Control Group | Diabetes 39 Instrument | Final total score | 30.4 score on a scale | Standard Deviation 24.5 |
Comparison: Comparing row Change from baseline at Week 12p-value: >0.05Wilcoxon (Mann-Whitney)
p-value: 0.0007Wilcoxon (Mann-Whitney)
p-value: >0.05Wilcoxon (Mann-Whitney)
Secondary
Diastolic Blood Pressure
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.
Time frame: At baseline, after 4, 8 and 12 weeks
Population: Intention-to-treat analysis was performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Diastolic Blood Pressure | Change from baseline at Week 12 | -2.32 mmHg | Standard Deviation 7.57 |
| Intervention Group | Diastolic Blood Pressure | Week 8 | 79.8 mmHg | Standard Deviation 9.1 |
| Intervention Group | Diastolic Blood Pressure | Baseline | 79.9 mmHg | Standard Deviation 8.23 |
| Intervention Group | Diastolic Blood Pressure | Final | 77.6 mmHg | Standard Deviation 9.96 |
| Intervention Group | Diastolic Blood Pressure | Week 4 | 78.7 mmHg | Standard Deviation 8.78 |
| Control Group | Diastolic Blood Pressure | Final | 75.7 mmHg | Standard Deviation 7.97 |
| Control Group | Diastolic Blood Pressure | Baseline | 78.1 mmHg | Standard Deviation 7.98 |
| Control Group | Diastolic Blood Pressure | Week 4 | 79 mmHg | Standard Deviation 7.77 |
| Control Group | Diastolic Blood Pressure | Week 8 | 76.6 mmHg | Standard Deviation 7.13 |
| Control Group | Diastolic Blood Pressure | Change from baseline at Week 12 | -2.36 mmHg | Standard Deviation 10.1 |
Comparison: Comparing row Change from baseline at Week 12p-value: >0.05Wilcoxon (Mann-Whitney)
p-value: >0.05ANOVA
p-value: >0.05Friedman
Secondary
Glucose
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.
Time frame: At baseline and after 12 weeks
Population: Intention-to-treat analysis was performed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Glucose | Change from baseline at Week 12 | -17 mg/dL | Standard Deviation 42.8 |
| Intervention Group | Glucose | Baseline mg/dL | 169 mg/dL | Standard Deviation 62.6 |
| Intervention Group | Glucose | Final mg/dL | 152 mg/dL | Standard Deviation 58.4 |
| Control Group | Glucose | Change from baseline at Week 12 | -38.1 mg/dL | Standard Deviation 55.9 |
| Control Group | Glucose | Baseline mg/dL | 195 mg/dL | Standard Deviation 85.7 |
| Control Group | Glucose | Final mg/dL | 157 mg/dL | Standard Deviation 63.6 |
Comparison: Comparing row Change from baseline at Week 12p-value: >0.05Wilcoxon (Mann-Whitney)
p-value: >0.05Wilcoxon (Mann-Whitney)
p-value: 0.0027Wilcoxon (Mann-Whitney)
Secondary
Glycated Hemoglobin A1c
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.
Time frame: At baseline and after 12 weeks
Population: Intention-to-treat analysis was performed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Glycated Hemoglobin A1c | Final % of glycated hemoglobin | 7.72 percentage of glycated hemoglobin | Standard Deviation 1.5 |
| Intervention Group | Glycated Hemoglobin A1c | Change from baseline at Week 12 | -0.17 percentage of glycated hemoglobin | Standard Deviation 1.09 |
| Intervention Group | Glycated Hemoglobin A1c | Baseline % of glycated hemoglobin | 7.82 percentage of glycated hemoglobin | Standard Deviation 1.9 |
| Control Group | Glycated Hemoglobin A1c | Change from baseline at Week 12 | -0.27 percentage of glycated hemoglobin | Standard Deviation 0.6 |
| Control Group | Glycated Hemoglobin A1c | Baseline % of glycated hemoglobin | 8.28 percentage of glycated hemoglobin | Standard Deviation 2.02 |
| Control Group | Glycated Hemoglobin A1c | Final % of glycated hemoglobin | 8 percentage of glycated hemoglobin | Standard Deviation 2.04 |
Comparison: Comparing row Change from baseline at Week 12p-value: >0.05Wilcoxon (Mann-Whitney)
p-value: >0.05Wilcoxon (Mann-Whitney)
p-value: 0.043Wilcoxon (Mann-Whitney)
Secondary
High-density Lipoprotein Cholesterol
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.
Time frame: At baseline and after 12 weeks
Population: Intention-to-treat analysis was performed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | High-density Lipoprotein Cholesterol | Change from baseline at Week 12 | -0.86 mg/dL | Standard Deviation 3.71 |
| Intervention Group | High-density Lipoprotein Cholesterol | Baseline mg/dL | 37.8 mg/dL | Standard Deviation 9.52 |
| Intervention Group | High-density Lipoprotein Cholesterol | Final mg/dL | 36.9 mg/dL | Standard Deviation 7.5 |
| Control Group | High-density Lipoprotein Cholesterol | Change from baseline at Week 12 | 2.18 mg/dL | Standard Deviation 6.23 |
| Control Group | High-density Lipoprotein Cholesterol | Baseline mg/dL | 38.2 mg/dL | Standard Deviation 9.12 |
| Control Group | High-density Lipoprotein Cholesterol | Final mg/dL | 40.4 mg/dL | Standard Deviation 6.26 |
Comparison: Comparing row Change from baseline at Week 12p-value: >0.05t-test, 2 sided
p-value: >0.05t-test, 2 sided
p-value: >0.05Wilcoxon (Mann-Whitney)
Secondary
Low-density Lipoprotein Cholesterol
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.
Time frame: At baseline and after 12 weeks
Population: Intention-to-treat analysis was performed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Low-density Lipoprotein Cholesterol | Change from baseline at Week 12 | 8.88 mg/dL | Standard Deviation 22.1 |
| Intervention Group | Low-density Lipoprotein Cholesterol | Baseline mg/dL | 112 mg/dL | Standard Deviation 31.8 |
| Intervention Group | Low-density Lipoprotein Cholesterol | Final mg/dL | 121 mg/dL | Standard Deviation 35.2 |
| Control Group | Low-density Lipoprotein Cholesterol | Change from baseline at Week 12 | 4.15 mg/dL | Standard Deviation 18.1 |
| Control Group | Low-density Lipoprotein Cholesterol | Baseline mg/dL | 108 mg/dL | Standard Deviation 31.3 |
| Control Group | Low-density Lipoprotein Cholesterol | Final mg/dL | 112 mg/dL | Standard Deviation 34.7 |
Comparison: Comparing row Change from baseline at Week 12p-value: >0.05Wilcoxon (Mann-Whitney)
p-value: >0.05Wilcoxon (Mann-Whitney)
p-value: >0.05t-test, 2 sided
Secondary
Neutrophil/Lymphocyte Ratio
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.
Time frame: At baseline and after 12 weeks
Population: Intention-to-treat analysis was performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Neutrophil/Lymphocyte Ratio | Change from baseline at Week 12 | -0.09 Ratio | Standard Deviation 0.77 |
| Intervention Group | Neutrophil/Lymphocyte Ratio | Baseline | 1.96 Ratio | Standard Deviation 0.86 |
| Intervention Group | Neutrophil/Lymphocyte Ratio | Final | 1.87 Ratio | Standard Deviation 1.07 |
| Control Group | Neutrophil/Lymphocyte Ratio | Change from baseline at Week 12 | 0.15 Ratio | Standard Deviation 0.45 |
| Control Group | Neutrophil/Lymphocyte Ratio | Baseline | 1.76 Ratio | Standard Deviation 0.55 |
| Control Group | Neutrophil/Lymphocyte Ratio | Final | 1.92 Ratio | Standard Deviation 0.61 |
Comparison: Comparing row Change from baseline at Week 12p-value: >0.05Wilcoxon (Mann-Whitney)
p-value: >0.05Wilcoxon (Mann-Whitney)
p-value: >0.05t-test, 2 sided
Secondary
Rate-dependent Depression of the H-reflex
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.
Time frame: At baseline and after 12 weeks
Population: H reflex was found only in 8 subjects of the intervention group and in 10 subjects of the control group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Rate-dependent Depression of the H-reflex | Baseline 1 Hz mean | 0.87 Ratio | Standard Deviation 0.35 |
| Intervention Group | Rate-dependent Depression of the H-reflex | Final 5 Hz mean | 0.89 Ratio | Standard Deviation 0.21 |
| Intervention Group | Rate-dependent Depression of the H-reflex | Change from baseline at Week 12 for 5 Hz | -0.02 Ratio | Standard Deviation 0.51 |
| Intervention Group | Rate-dependent Depression of the H-reflex | Change from baseline at Week 12 for 10 Hz | 0.13 Ratio | Standard Deviation 0.28 |
| Intervention Group | Rate-dependent Depression of the H-reflex | Final 1 Hz mean | 0.99 Ratio | Standard Deviation 0.28 |
| Intervention Group | Rate-dependent Depression of the H-reflex | Baseline 10 Hz mean | 0.56 Ratio | Standard Deviation 0.47 |
| Intervention Group | Rate-dependent Depression of the H-reflex | Baseline 5 Hz mean | 0.91 Ratio | Standard Deviation 0.67 |
| Intervention Group | Rate-dependent Depression of the H-reflex | Final 10 Hz mean | 0.72 Ratio | Standard Deviation 0.25 |
| Intervention Group | Rate-dependent Depression of the H-reflex | Change from baseline at Week 12 for 1 Hz | 0.13 Ratio | Standard Deviation 0.36 |
| Control Group | Rate-dependent Depression of the H-reflex | Final 10 Hz mean | 0.62 Ratio | Standard Deviation 0.3 |
| Control Group | Rate-dependent Depression of the H-reflex | Change from baseline at Week 12 for 1 Hz | 0.01 Ratio | Standard Deviation 0.28 |
| Control Group | Rate-dependent Depression of the H-reflex | Baseline 1 Hz mean | 0.88 Ratio | Standard Deviation 0.33 |
| Control Group | Rate-dependent Depression of the H-reflex | Final 1 Hz mean | 0.89 Ratio | Standard Deviation 0.16 |
| Control Group | Rate-dependent Depression of the H-reflex | Change from baseline at Week 12 for 5 Hz | -0.03 Ratio | Standard Deviation 0.3 |
| Control Group | Rate-dependent Depression of the H-reflex | Baseline 5 Hz mean | 0.71 Ratio | Standard Deviation 0.38 |
| Control Group | Rate-dependent Depression of the H-reflex | Final 5 Hz mean | 0.65 Ratio | Standard Deviation 0.27 |
| Control Group | Rate-dependent Depression of the H-reflex | Change from baseline at Week 12 for 10 Hz | -0.06 Ratio | Standard Deviation 0.2 |
| Control Group | Rate-dependent Depression of the H-reflex | Baseline 10 Hz mean | 0.71 Ratio | Standard Deviation 0.42 |
Comparison: For 1 Hzp-value: >0.05Wilcoxon (Mann-Whitney)
Comparison: 5 and 10 Hzp-value: >0.05t-test, 2 sided
Comparison: For 1, 5 and 10 Hzp-value: >0.05t-test, 2 sided
Comparison: For 1, 5 and 10 Hzp-value: >0.05t-test, 2 sided
Secondary
Systolic Blood Pressure
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.
Time frame: At baseline, after 4, 8 and 12 weeks
Population: Intention-to-treat analysis was performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Systolic Blood Pressure | Baseline | 126 mmHg | Standard Deviation 14.6 |
| Intervention Group | Systolic Blood Pressure | Week 8 | 122 mmHg | Standard Deviation 12.2 |
| Intervention Group | Systolic Blood Pressure | Week 4 | 125 mmHg | Standard Deviation 13.5 |
| Intervention Group | Systolic Blood Pressure | Final | 122 mmHg | Standard Deviation 14.2 |
| Intervention Group | Systolic Blood Pressure | Change from baseline at Week 12 | -3.7 mmHg | Standard Deviation 11 |
| Control Group | Systolic Blood Pressure | Final | 124 mmHg | Standard Deviation 11.7 |
| Control Group | Systolic Blood Pressure | Change from baseline at Week 12 | -3.78 mmHg | Standard Deviation 14.8 |
| Control Group | Systolic Blood Pressure | Baseline | 127 mmHg | Standard Deviation 15.5 |
| Control Group | Systolic Blood Pressure | Week 4 | 130 mmHg | Standard Deviation 17.2 |
| Control Group | Systolic Blood Pressure | Week 8 | 125 mmHg | Standard Deviation 9.7 |
Comparison: Comparing row Change from baseline at Week 12p-value: >0.05Wilcoxon (Mann-Whitney)
p-value: >0.05ANOVA
p-value: >0.05Friedman
Secondary
Triglycerides
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.
Time frame: At baseline and after 12 weeks
Population: Intention-to-treat analysis was performed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Triglycerides | Change from baseline at Week 12 | -4.96 mg/dL | Standard Deviation 60.2 |
| Intervention Group | Triglycerides | Baseline mg/dL | 182 mg/dL | Standard Deviation 81.4 |
| Intervention Group | Triglycerides | Final mg/dL | 177 mg/dL | Standard Deviation 78.8 |
| Control Group | Triglycerides | Change from baseline at Week 12 | -13.9 mg/dL | Standard Deviation 44.6 |
| Control Group | Triglycerides | Baseline mg/dL | 179 mg/dL | Standard Deviation 58.8 |
| Control Group | Triglycerides | Final mg/dL | 165 mg/dL | Standard Deviation 52.1 |
Comparison: Comparing row Change from baseline at Week 12p-value: >0.05Wilcoxon (Mann-Whitney)
p-value: >0.05Wilcoxon (Mann-Whitney)
p-value: >0.05t-test, 2 sided
Secondary
Triglycerides/HDL Ratio
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.
Time frame: At baseline and after 12 weeks
Population: Intention-to-treat analysis was performed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Triglycerides/HDL Ratio | Baseline | 5.12 Ratio | Standard Deviation 2.84 |
| Intervention Group | Triglycerides/HDL Ratio | Change from baseline at Week 12 | -0.02 Ratio | Standard Deviation 1.98 |
| Intervention Group | Triglycerides/HDL Ratio | Final | 5.1 Ratio | Standard Deviation 2.9 |
| Control Group | Triglycerides/HDL Ratio | Baseline | 4.99 Ratio | Standard Deviation 2.13 |
| Control Group | Triglycerides/HDL Ratio | Change from baseline at Week 12 | -0.74 Ratio | Standard Deviation 2.13 |
| Control Group | Triglycerides/HDL Ratio | Final | 4.25 Ratio | Standard Deviation 1.31 |
Comparison: Comparing row Change from baseline at Week 12p-value: >0.05Wilcoxon (Mann-Whitney)
p-value: >0.05Wilcoxon (Mann-Whitney)
p-value: >0.05t-test, 2 sided
Secondary
Waist Circumference
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.
Time frame: At baseline, after 4, 8 and 12 weeks
Population: Intention-to-treat analysis was performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Waist Circumference | Week 4 | 96.5 cm | Standard Deviation 7.08 |
| Intervention Group | Waist Circumference | Week 8 | 96 cm | Standard Deviation 7.33 |
| Intervention Group | Waist Circumference | Baseline | 96.7 cm | Standard Deviation 7.49 |
| Intervention Group | Waist Circumference | Final | 95.9 cm | Standard Deviation 7.28 |
| Intervention Group | Waist Circumference | Change from baseline at Week 12 | -0.8 cm | Standard Deviation 2.19 |
| Control Group | Waist Circumference | Final | 102 cm | Standard Deviation 12 |
| Control Group | Waist Circumference | Change from baseline at Week 12 | -1.38 cm | Standard Deviation 4.11 |
| Control Group | Waist Circumference | Baseline | 103 cm | Standard Deviation 13.1 |
| Control Group | Waist Circumference | Week 8 | 103 cm | Standard Deviation 12 |
| Control Group | Waist Circumference | Week 4 | 103 cm | Standard Deviation 11.7 |
Comparison: Comparing row Change from baseline at Week 12p-value: >0.05t-test, 2 sided
p-value: >0.05ANOVA
p-value: >0.05ANOVA
Secondary
Waist-to-Height Ratio
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.
Time frame: At baseline, after 4, 8 and 12 weeks
Population: We could not obtain the height from 1 subject from the cocoa group. Intention-to-treat analysis was performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Waist-to-Height Ratio | Baseline | 0.6 Ratio | Standard Deviation 0.04 |
| Intervention Group | Waist-to-Height Ratio | Week 8 | 0.6 Ratio | Standard Deviation 0.04 |
| Intervention Group | Waist-to-Height Ratio | Week 4 | 0.6 Ratio | Standard Deviation 0.04 |
| Intervention Group | Waist-to-Height Ratio | Final | 0.6 Ratio | Standard Deviation 0.04 |
| Intervention Group | Waist-to-Height Ratio | Change from baseline at Week 12 | -0.00 Ratio | Standard Deviation 0.01 |
| Control Group | Waist-to-Height Ratio | Final | 0.63 Ratio | Standard Deviation 0.09 |
| Control Group | Waist-to-Height Ratio | Change from baseline at Week 12 | -0.00 Ratio | Standard Deviation 0.02 |
| Control Group | Waist-to-Height Ratio | Baseline | 0.64 Ratio | Standard Deviation 0.09 |
| Control Group | Waist-to-Height Ratio | Week 4 | 0.64 Ratio | Standard Deviation 0.08 |
| Control Group | Waist-to-Height Ratio | Week 8 | 0.64 Ratio | Standard Deviation 0.09 |
Comparison: Comparing row Change from baseline at Week 12p-value: >0.05t-test, 2 sided
p-value: >0.05ANOVA
p-value: >0.05ANOVA
Secondary
Weight
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.
Time frame: At baseline, after 4, 8 and 12 weeks
Population: We could not obtain the weight measure from one participant of the intervention group.~Intention-to-treat analysis was performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Weight | Baseline | 73.5 kg | Standard Deviation 14.1 |
| Intervention Group | Weight | Week 8 | 74.1 kg | Standard Deviation 14.7 |
| Intervention Group | Weight | Week 4 | 74.4 kg | Standard Deviation 14.8 |
| Intervention Group | Weight | Final | 73.8 kg | Standard Deviation 14.6 |
| Intervention Group | Weight | Change from baseline at Week 12 | 0.38 kg | Standard Deviation 2.72 |
| Control Group | Weight | Final | 82.4 kg | Standard Deviation 13.9 |
| Control Group | Weight | Change from baseline at Week 12 | -0.42 kg | Standard Deviation 2.18 |
| Control Group | Weight | Baseline | 82.8 kg | Standard Deviation 13.8 |
| Control Group | Weight | Week 4 | 82.5 kg | Standard Deviation 13.9 |
| Control Group | Weight | Week 8 | 83 kg | Standard Deviation 13.7 |
Comparison: Comparing row Change from baseline at Week 12p-value: >0.05Wilcoxon (Mann-Whitney)
p-value: >0.05ANOVA
p-value: >0.05ANOVA