Amla on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

NCT03633630 | Completed Phase 2 DMC

• 1 other identifier: Amla MS
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

Amla; Emblica officinalis; Metabolic Syndrome; Insulin Secretion; Insulin Sensitivity

Outcome Measures

Primary Outcomes (6)

• Waist Circumference (WC)

  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.

  90 days

• Triglycerides (TGs)

  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.

  90 days

• High-density Lipoprotein Cholesterol (HDL-C)

  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.

  90 days

• Fasting Plasma Glucose (FPG)

  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.

  90 days

• Systolic Blood Pressure (SBP)

  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.

  90 days

• Diastolic Blood Pressure (DBP)

  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.

  90 days

Study Arms (2)

Amla (Emblica Officinalis)

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

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

Also known as: Emblica Officinalis

Amla (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

Also known as: Calcined Magnesia

Placebo

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Institute of Experimental and Clinical Therapeutics

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (30)

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• Chen TS, Liou SY, Chang YL. Supplementation of Emblica officinalis (Amla) extract reduces oxidative stress in uremic patients. Am J Chin Med. 2009;37(1):19-25. doi: 10.1142/S0192415X09006680.

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MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Esperanza Martínez-Abundis, PhD

  Institute of Experimental and Clinical Therapeutics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher Professor

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 16, 2018
• Study Start: April 1, 2019
• Primary Completion: October 30, 2021
• Study Completion: March 30, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)