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The metabolic syndrome is characterized by the presence of overweight/obesity, insulin resistance, hyperglycemia, dyslipidaemia and hypertension and an inflammatory state, which together increase the risk of developing cardiovascular disease (CVD) or diabetes mellitus type 2 (DM2). It is also characterized by a decreased insulin sensitivity, namely, lower ability of insulin to metabolize glucose, key in the physiopathogeny of disease process.
In the search for a pharmacological agent that can attend more components of the metabolic syndrome and above all improve insulin sensitivity to effectively prevent the development of CVD and DM2, ursolic acid is a promising compound.
Ursolic acid is a pentacyclic carboxylic acid present in medicinal herbs, parts of some fruits like apple peel, and plants such as rosemary. There is scientific evidence of important benefits of ursolic acid level in vitro and in vivo on insulin, metabolism of lipids and glucose, as well as on the body weight and metabolic parameters. However, the results are not clear and the mechanisms are not fully elucidate.
The aim of this study is to evaluate the effect of ursolic acid on the insulin sensitivity and metabolic syndrome.
A randomized, double-blind, placebo-controlled clinical trial in 24 patients of both sexes aged between 30 and 60 years, with a diagnosis of metabolic syndrome according to the modified International Diabetes Federation (IDF) criteria, without treatment.
They will be assigned randomly two groups of 12 patients, each to receive 150 mg of ursolic acid or placebo before breakfast for 12 weeks.
Insulin sensitivity will be calculated by Matsuda Index with dates from glucose and insulin levels from Oral Glucose Tolerance Test; Waist circumference will be measured; triglycerides and High density lipoprotein (HDL-C) and blood pressure will be evaluated before and after intervention in both groups.
Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2, will be used for differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. Will be considered statistical significance p ≤0.05.
This protocol was approved by a local ethics committee (CEI/075/2014) and written informed consent will be obtained from all volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ursolic acid | Experimental | Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks |
|
| Placebo | Placebo Comparator | Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ursolic acid | Drug | Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Insulin Sensitivity | The insulin sensitivity was calculated at baseline and at week 12. The value reported corresponds at week 12 with Matsuda index. Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity | Week 12 |
| Waist Circumference | Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflect the waist circumference measure at week 12 | Week 12 |
| Fasting Glucose | The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12 | Week 12 |
| Triglycerides | The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12 | Week 12 |
| High Density Lipoprotein Cholesterol (HDL-c) | The HDL-c levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12 | Week 12 |
| Systolic Blood Pressure | The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | The body weight was measured at baseline and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12 | Week 12 |
| Body Mass Index | The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manuel González-Ortíz, PhD | University of Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Terapéutica Experimental y Clínica | Guadalajara | Jalisco | 44140 | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ursolic Acid | Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast |
| FG001 | Placebo | Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ursolic Acid | Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Insulin Sensitivity | The insulin sensitivity was calculated at baseline and at week 12. The value reported corresponds at week 12 with Matsuda index. Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity | Posted | Mean | Standard Deviation | index | Week 12 |
|
Throughout the study (12 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ursolic Acid | Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distention | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DR. MANUEL GONZALEZ ORTIZ | INSTITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA | +52 3310585200 | 34212 | uiec@prodigy.net.mx |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D056128 | Obesity, Abdominal |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000097245 | Ursolic Acid |
| ID | Term |
|---|---|
| D053978 | Pentacyclic Triterpenes |
| D014315 | Triterpenes |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
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| Placebo | Drug | Calcined magnesia capsules of 150 mg, once a day before breakfast |
|
|
| Week 12 |
| Diastolic Blood Pressure | The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12 | Week 12 |
| Week 12 |
| Total Cholesterol | The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12 | Week 12 |
| Low Density Lipoproteins Cholesterol (LDL-c) | The LDL-c levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12 | Week 12 |
| Creatinine | The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinine levels at week 12 | Week 12 |
| Uric Acid | The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12 | Week 12 |
Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks
Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Total Insulin Sensitivity | Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity | Mean | Standard Deviation | index |
|
| Waist Circumference | Mean | Standard Deviation | cm |
|
| Fasting Glucose | Mean | Standard Deviation | mmol/L |
|
| Triglycerides | Mean | Standard Deviation | mmol/L |
|
| High Density Lipoprotein cholesterol (HDL-c) | Mean | Standard Deviation | mmol/L |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Body Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Total Cholesterol | Mean | Standard Deviation | mmol/L |
|
| Low Density Lipoproteins cholesterol (LDL-c) | Mean | Standard Deviation | mmol/L |
|
| Creatinine | Mean | Standard Deviation | µmol/L |
|
| Uric acid | Mean | Standard Deviation | µmol/L |
|
Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks
Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast
|
|
|
| Primary | Waist Circumference | Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflect the waist circumference measure at week 12 | Posted | Mean | Standard Deviation | cm | Week 12 |
|
|
|
|
| Primary | Fasting Glucose | The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12 | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Primary | Triglycerides | The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12 | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Primary | High Density Lipoprotein Cholesterol (HDL-c) | The HDL-c levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12 | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Primary | Systolic Blood Pressure | The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12 | Posted | Mean | Standard Deviation | mmHg | Week 12 |
|
|
|
|
| Primary | Diastolic Blood Pressure | The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12 | Posted | Mean | Standard Deviation | mmHg | Week 12 |
|
|
|
|
| Secondary | Body Weight | The body weight was measured at baseline and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12 | Posted | Mean | Standard Deviation | kg | Week 12 |
|
|
|
|
| Secondary | Body Mass Index | The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12 | Posted | Mean | Standard Deviation | kg/m^2 | Week 12 |
|
|
|
|
| Secondary | Total Cholesterol | The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12 | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Secondary | Low Density Lipoproteins Cholesterol (LDL-c) | The LDL-c levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12 | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Secondary | Creatinine | The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinine levels at week 12 | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Secondary | Uric Acid | The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12 | Posted | Mean | Standard Deviation | µmol/L | Week 12 |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 4 |
| 12 |
| EG001 | Placebo | Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast | 0 | 12 | 0 | 12 | 6 | 12 |
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
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| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D012502 | Sapogenins |