Amla on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

Phase 2

Completed

• Conditions: Metabolic Syndrome
• Interventions: Drug: Amla; Drug: Placebo

• Registration Number: NCT03633630
• Lead Sponsor: University of Guadalajara

Brief 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).

Study Timeline

• Study First Submitted: 2018-08-14
• Study First Submitted QC: 2018-08-15
• Study First Posted: 2018-08-16
• Study Start: 2019-04-01
• Primary Completion: 2021-10-30
• Study Completion: 2022-03-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amla (Emblica Officinalis)	Amla	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	1000 mg dose per day. Two capsules of 500 mg, one in the morning before breakfast and the other before dinner during 90 days

Primary Outcome Measures

Name	Time	Method
Diastolic Blood Pressure (DBP)	90 days	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.
Waist Circumference (WC)	90 days	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.
Triglycerides (TGs)	90 days	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.
Fasting Plasma Glucose (FPG)	90 days	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.
Systolic Blood Pressure (SBP)	90 days	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.
High-density Lipoprotein Cholesterol (HDL-C)	90 days	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.

Trial Locations

Locations (1)

Institute of Experimental and Clinical Therapeutics; 🇲🇽 Guadalajara, Jalisco, Mexico