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Amla has demonstrated promising effects in the treatment of obesity, dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings show that Amla has an excellent potential for the prevention and treatment of metabolic syndrome.
A randomized, double-blind, placebo-controlled clinical trial will be conducted in 28 patients, 30-59 years old, with diagnosis of Metabolic Syndrome according with modified International Diabetes Federation criteria. Patients will be randomly assigned to receive Amla (500mg) or homologated placebo orally twice daily, for 90 days. Before and after the intervention, the components of Metabolic Syndrome will be evaluated, waist circumference, blood pressure, levels of fasting glucose, triglycerides, cholesterol high density lipoprotein (C-HDL), total insulin secretion (Insulinogenic index), first phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amla (Emblica Officinalis) | Experimental | 1000 mg dose per day. Two capsules of 500 mg, one in the morning before breakfast and the other before dinner during 90 days. |
|
| Placebo | Placebo Comparator | 1000 mg dose per day. Two capsules of 500 mg, one in the morning before breakfast and the other before dinner during 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amla | Drug | Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Waist Circumference (WC) | The WC will be evaluated after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest. The value will be expressed in centimeters. | 90 days |
| Triglycerides (TGs) | The blood sample for determining of TGs, will be taken after an overnight fast and with a spectrophotometry method. The value will be expressed on mmol/L. | 90 days |
| High-density Lipoprotein Cholesterol (HDL-C) | The blood sample for determining of HDL-C, will be taken after an overnight fast with a colorimetric method. The value will be expressed on mmol/L. | 90 days |
| Fasting Plasma Glucose (FPG) | The blood sample for determining of FPG, will be taken after an overnight fast and with a spectrophotometry method. The value will be expressed on mmol/L. | 90 days |
| Systolic Blood Pressure (SBP) | The SBP will be 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 will be considered as the value of SBP. The value will be expressed on mmHg. | 90 days |
| Diastolic Blood Pressure (DBP) | The DBP will be 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 will be considered as the value of DBP. The value will be expressed on mmHg. | 90 days |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esperanza MartÃnez-Abundis, PhD | Institute of Experimental and Clinical Therapeutics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Experimental and Clinical Therapeutics | Guadalajara | Jalisco | 44340 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26275865 | Background | Athyros VG, Mikhailidis DP. High incidence of metabolic syndrome further increases cardiovascular risk in patients with type 2 diabetes. Implications for everyday practice. J Diabetes Complications. 2016 Jan-Feb;30(1):9-11. doi: 10.1016/j.jdiacomp.2015.07.012. Epub 2015 Jul 17. No abstract available. | |
| 24582089 | Background |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| 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 | Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days |
|
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