Amla on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Effect of Amla Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion.

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Drug: Amla
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Diagnosed Metabolic Syndrome according to the IDF criteria: - - Waist circumference: ≥80 cm (women) ≥90 cm (men), plus two or more of the following: - - Fasting glucose ≥ 100 mg/dL to <126 mg/dL. - - Triglycerides ≥150 mg/dL to <499 mg/dL - - HDL-C: Men ≤40 mg/dL, women ≤50 mg/dL - - Systolic blood pressure ≥130 to <140 mmHg - - Diastolic blood pressure ≥85 to <89 mmHg Body Mass Index between 25 and 34.9 kg/m² No pharmacological treatment for Metabolic Syndrome Exclusion Criteria: Pregnancy or breast-feeding Known allergy to Amla or placebo History of hepatic, kidney or thyroid disease Drugs or supplements consumption with proven properties that modify the behavior of the Metabolic Syndrome

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amla (Emblica Officinalis)<br>1000 mg dose per day. Two capsules of 500 mg, one in the morning before breakfast and the other before dinner during 90 days. | Drug: Amla<br>* Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days<br>* Other names: Emblica Officinalis;|
| Placebo Comparator: Placebo<br>1000 mg dose per day. Two capsules of 500 mg, one in the morning before breakfast and the other before dinner during 90 days | Drug: Placebo<br>* Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days<br>* Other names: Calcined Magnesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amla, Emblica officinalis, Metabolic Syndrome, Insulin Secretion, Insulin Sensitivity