Amla on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

University of Guadalajara

Status and phase: Completed; Phase 3; Phase 2

Conditions: Metabolic Syndrome

Treatments: Drug: Amla; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03633630

Amla MS

Details and patient eligibility

About

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.

Full 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).

Enrollment: 28 patients

Sex: All

Ages: 30 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 2 patient groups, including a placebo group

Amla (Emblica Officinalis)

Experimental group

Description:

1000 mg dose per day. Two capsules of 500 mg, one in the morning before breakfast and the other before dinner during 90 days.

Treatment:

Drug: Amla

Placebo

Placebo Comparator group

Description:

1000 mg dose per day. Two capsules of 500 mg, one in the morning before breakfast and the other before dinner during 90 days

Treatment:

Drug: Placebo