NCT03633630

Amla on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of Guadalajara · Academic / Other
• Sex: All
• Age: 30 Years – 59 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
DRUG	Amla	Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days
DRUG	Placebo	Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days

Timeline

• Start date: 2019-04-01
• Primary completion: 2021-10-30
• Completion: 2022-03-30
• First posted: 2018-08-16
• Last updated: 2022-11-08

Locations

1 site across 1 country: Mexico