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The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease.
Banaba has shown evidence that has on metabolic syndrome, insulin sensitivity and insulin secretion.
The investigators hypothesis was that the the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.
A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, and lipid profile were evaluated after a 75 g of dextrose load.
12 received Banaba, 500 mg, two times per day (1000 mg) before meals during 3 months.
The remaining 12 patients received placebo with the same prescription.
Area Under the Curve of glucose and insulin was calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).
This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers.
Results are presented as mean and standard deviation. Intra and inter group differences were tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 was considered significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Banaba | Experimental | Banaba capsules, 500mg, two times per day before meals during 90 days |
|
| Placebo | Placebo Comparator | Calcined magnesia capsules, 500mg, two times per day before meals during 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Banaba | Drug | Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Triglyceride Levels at Week 12 | The triglycerides will be evaluated at week 12 with enzymatic-colorimetric techniques. | Week 12 |
| High Density Lipoprotein-cholesterol (HDL-C) Levels at Week 12 | The HDL-C levels will be evaluated at week 12 with enzymatic/colorimetric techniques. | Week 12 |
| Fasting Glucose Levels at Week 12 | 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 |
| Systolic Blood Pressure at Week 12. | 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 | Week 12 |
| First Phase of Insulin Secretion at Week 12 | Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the frst phase of insulin secretion at week 12. | Week 12 |
| Total Insulin Secretion at Week 12. | Measure Description: The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight at Week 12 | The 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 at Week 12 | 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:
And two of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MANUEL GONZALEZ, PhD | University of Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara | Guadalajara | Jalisco | 45037 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34726501 | Derived | Lopez-Murillo LD, Gonzalez-Ortiz M, Martinez-Abundis E, Cortez-Navarrete M, Perez-Rubio KG. Effect of Banaba (Lagerstroemia speciosa) on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion. J Med Food. 2022 Feb;25(2):177-182. doi: 10.1089/jmf.2021.0039. Epub 2021 Nov 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Banaba | Banaba capsules, 500mg, two times per day before meals during 90 days Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day. |
| FG001 | Placebo | Calcined magnesia capsules, 500mg, two times per day before meals during 90 days placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Sample size was calculated in accordance of Jeyaseelan's clinical trial formula with a statistical confidence of 95%, statistical power of 80%, obtaining a total of 12 patients per group including 20% of expected loss.
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| ID | Title | Description |
|---|---|---|
| BG000 | Banaba | Banaba capsules, 500mg, two times per day before meals during 90 days Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Triglyceride Levels at Week 12 | The triglycerides will be evaluated at week 12 with enzymatic-colorimetric techniques. | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mg/dL | Week 12 |
|
Adverse events were collected throughout the 12-week study.
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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 | Banaba | Banaba capsules, 500mg, two times per day before meals during 90 days Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| softening of stool | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Manuel González Ortiz | Institute of Experimental andl Clinical Therapeutics | +52-33-10-58-52-00 | 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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| placebo | Drug | Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg |
|
|
| Week 12 |
| Total Insulin Sensitivity at Week 12 | 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 at week 12. | Week 12 |
| Waist Circumference at Week 12 | Waist circumference will be evaluated at baseline and at week 12 with a flexible tape | Week 12 |
| Diastolic Blood Pressure at Week 12 | 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 at Week 12 | 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 Lipoprotein-cholesterol (LDL-C) at Week 12 | 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 |
Calcined magnesia capsules, 500mg, two times per day before meals during 90 days
placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body weight | Body weight was evaluated through a bioimpedance digital scale and results are reported in kg with a decimal. | Mean | Standard Deviation | kg |
|
| Body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Waist circumference | Waist circumference was measured with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters. | Mean | Standard Deviation | cm |
|
| Systolic blood pressure | Measure Description: Blood pressure was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of systolic blood pressure (SBP) and diastolic (DBP). The value was expressed on mmHg | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Measure Description: Blood pressure was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of systolic blood pressure (SBP) and diastolic (DBP). The value was expressed on mmHg | Mean | Standard Deviation | mmHg |
|
| Glucose 0' | Measure Description: The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 0 and 120 after a 75 g oral dextrose load. | Mean | Standard Deviation | mg/dL |
|
| Glucose 120' | Measure Description: The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load. | Mean | Standard Deviation | mg/dL |
|
| Cholesterol | Measure Description: The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots to determine cholesterol | Mean | Standard Deviation | mg/dL |
|
| Triglycerides | Measure Description: The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine triglycerides | Mean | Standard Deviation | mg/dL |
|
| High-density lipoprotein-cholesterol (HDL-C) | The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into aliquots: the first was immediately analyzed to determine high-density lipoprotein-cholesterol (HDL-C) | Mean | Standard Deviation | mg/dL |
|
| Low-density lipoprotein-cholesterol (LDL-C) | The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine low-density lipoprotein-cholesterol (LDL-C). | Mean | Standard Deviation | mg/dL |
|
| Area under the curve (AUC) glucose | The area under the curve (AUC) of glucose, (0.5 * glucose (G) 0´ + (G 30´+G 60´ + G 90´) + 0.5 * G 120´) * 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperglycemia. | Mean | Standard Deviation | mg*min/dL |
|
| Area under the curve (AUC) insulin | The area under the curve (AUC) of insulin, (0.5 * Insulin (I) 0´ + (I 30´+I 60´ + I 90´) + 0.5 * I 120´) * 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperinsulinemia. | Mean | Standard Deviation | uU*min/mL |
|
| Very low-density lipoprotein (VLDL) | Mean | Standard Deviation | mg/dL |
|
| Total insulin secretion | The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at baseline. | Mean | Standard Deviation | index |
|
| First phase of insulin secretion | Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the frst phase of insulin secretion at baseline. | Mean | Standard Deviation | index |
|
| 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 at baseline | Mean | Standard Deviation | index |
|
|
|
|
| Primary | High Density Lipoprotein-cholesterol (HDL-C) Levels at Week 12 | The HDL-C levels will be evaluated at week 12 with enzymatic/colorimetric techniques. | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mg/dL | Week 12 |
|
|
|
|
| Primary | Fasting Glucose Levels at Week 12 | 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 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mg/dL | Week 12 |
|
|
|
|
| Primary | Systolic Blood Pressure at Week 12. | 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 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mmHg | Week 12 |
|
|
|
|
| Primary | First Phase of Insulin Secretion at Week 12 | Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the frst phase of insulin secretion at week 12. | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | index | Week 12 |
|
|
|
|
| Primary | Total Insulin Secretion at Week 12. | Measure Description: The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12. | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | index | Week 12 |
|
|
|
|
| Primary | Total Insulin Sensitivity at Week 12 | 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 at week 12. | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | index | Week 12 |
|
|
|
|
| Primary | Waist Circumference at Week 12 | Waist circumference will be evaluated at baseline and at week 12 with a flexible tape | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | cm | Week 12 |
|
|
|
|
| Primary | Diastolic Blood Pressure at Week 12 | 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 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mmHg | Week 12 |
|
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|
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| Secondary | Weight at Week 12 | The weight was measured at baseline and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | kg | Week 12 |
|
|
|
|
| Secondary | Body Mass Index at Week 12 | 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 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | kg/m^2 | Week 12 |
|
|
|
|
| Secondary | Total Cholesterol at Week 12 | 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 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mg/dL | Week 12 |
|
|
|
|
| Secondary | Low-density Lipoprotein-cholesterol (LDL-C) at Week 12 | 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 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mg/dL | Week 12 |
|
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|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 12 |
| 12 |
| EG001 | Placebo | Calcined magnesia capsules, 500mg, two times per day before meals during 90 days placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg | 0 | 12 | 0 | 12 | 9 | 12 |
| abdominal colic | Gastrointestinal disorders | Systematic Assessment |
|
| flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| abdominal swelling | Gastrointestinal disorders | Systematic Assessment |
|
| pyrosis | 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 |