Amla on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

Last updated: November 4, 2022
Sponsor: University of Guadalajara
Overall Status: Completed

Phase

2/3

Condition

Metabolic Syndrome

Allergy

High Cholesterol (Hyperlipidemia)

Treatment

N/A

Clinical Study ID

NCT03633630
Amla MS
  • Ages 30-59
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Diagnosed Metabolic Syndrome according to the IDF criteria:
      • Waist circumference: ≥80 cm (women) ≥90 cm (men), plus two or more of thefollowing:
      • 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

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 ofthe Metabolic Syndrome

Study Design

Total Participants: 28
Study Start date:
April 01, 2019
Estimated Completion Date:
March 30, 2022

Study Description

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).

Connect with a study center

  • Institute of Experimental and Clinical Therapeutics

    Guadalajara, Jalisco 44340
    Mexico

    Site Not Available

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