Clinical trial NCT03633630: Amla on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Official title: Effect of Amla Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Metabolic Syndrome
Keywords: Amla
Emblica officinalis
Metabolic Syndrome
Insulin Secretion
Insulin Sensitivity
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Waist Circumference (WC)
timeFrame: 90 days
measure: Triglycerides (TGs)
timeFrame: 90 days
measure: High-density Lipoprotein Cholesterol (HDL-C)
timeFrame: 90 days
measure: Fasting Plasma Glucose (FPG)
timeFrame: 90 days
measure: Systolic Blood Pressure (SBP)
timeFrame: 90 days
measure: Diastolic Blood Pressure (DBP)
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Institute of Experimental and Clinical Therapeutics
state: Jalisco
Study officials:
affiliation: Institute of Experimental and Clinical Therapeutics
name: Esperanza Martínez-Abundis, PhD
role: PRINCIPAL_INVESTIGATOR
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