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Amla on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03633630
Recruitment Status : Completed
First Posted : August 16, 2018
Last Update Posted : November 8, 2022
Sponsor:
Information provided by (Responsible Party):
Esperanza Martínez-Abundis, University of Guadalajara

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Drug: Amla Drug: Placebo Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Amla Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion.
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : October 30, 2021
Actual Study Completion Date : March 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Amla (Emblica Officinalis)
1000 mg dose per day. Two capsules of 500 mg, one in the morning before breakfast and the other before dinner during 90 days.
 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
Other Name: Emblica Officinalis
Placebo Comparator: 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
 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
Other Name: Calcined Magnesia


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633630


Locations
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Mexico
Institute of Experimental and Clinical Therapeutics
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
University of Guadalajara
Investigators
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Principal Investigator: Esperanza Martínez-Abundis, PhD Institute of Experimental and Clinical Therapeutics
More Information
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Publications:

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Responsible Party: Esperanza Martínez-Abundis, Researcher Professor, University of Guadalajara
ClinicalTrials.gov Identifier: NCT03633630    
Other Study ID Numbers: Amla MS
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: November 8, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Esperanza Martínez-Abundis, University of Guadalajara:
Amla
Emblica officinalis
Metabolic Syndrome
Insulin Secretion
Insulin Sensitivity
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hypersensitivity
Syndrome
Disease
Pathologic Processes
Immune System Diseases
 Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Magnesium Oxide
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents