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Completed

NCT Number: NCT03633630

Amla on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Institute of Experimental and Clinical Therapeutics

Guadalajara, Jalisco, 44340, Mexico

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amla

Drug

Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days

Other names: Emblica Officinalis

Placebo

Drug

Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days

Other names: Calcined Magnesia

Primary outcomes

  1. Waist Circumference (WC)

    Time frame: 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.

  2. Triglycerides (TGs)

    Time frame: 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.

  3. High-density Lipoprotein Cholesterol (HDL-C)

    Time frame: 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.

  4. Fasting Plasma Glucose (FPG)

    Time frame: 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.

  5. Systolic Blood Pressure (SBP)

    Time frame: 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.

  6. Diastolic Blood Pressure (DBP)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 16, 2018
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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