Amla on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

University of Guadalajara28 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Metabolic Syndrome

Interventions

AmlaDRUG

Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days

PlaceboDRUG

Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days

Eligibility

Sex: ALLMin age: 30 YearsMax age: 59 Years

Medical Language ↔ Plain English

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

Locations (1)

Institute of Experimental and Clinical Therapeutics

Guadalajara, Jalisco, Mexico

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 90 days

Data from ClinicalTrials.gov

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