Back to resultsAmla on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Amla
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring Amla, Emblica officinalis, Metabolic Syndrome, Insulin Secretion, Insulin Sensitivity
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
Sites / Locations
- Institute of Experimental and Clinical Therapeutics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Amla (Emblica Officinalis)
Placebo
Arm 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.
1000 mg dose per day. Two capsules of 500 mg, one in the morning before breakfast and the other before dinner during 90 days
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03633630
First Posted
August 14, 2018
Last Updated
November 4, 2022
Sponsor
University of Guadalajara
1. Study Identification
Unique Protocol Identification Number
NCT03633630
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
March 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guadalajara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Amla, Emblica officinalis, Metabolic Syndrome, Insulin Secretion, Insulin Sensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amla (Emblica Officinalis)
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Amla
Other Intervention Name(s)
Emblica Officinalis
Intervention Description
Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Calcined Magnesia
Intervention Description
Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days
Primary Outcome Measure Information:
Title
Waist Circumference (WC)
Description
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.
Time Frame
90 days
Title
Triglycerides (TGs)
Description
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.
Time Frame
90 days
Title
High-density Lipoprotein Cholesterol (HDL-C)
Description
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.
Time Frame
90 days
Title
Fasting Plasma Glucose (FPG)
Description
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.
Time Frame
90 days
Title
Systolic Blood Pressure (SBP)
Description
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.
Time Frame
90 days
Title
Diastolic Blood Pressure (DBP)
Description
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.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esperanza Martínez-Abundis, PhD
Organizational Affiliation
Institute of Experimental and Clinical Therapeutics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Experimental and Clinical Therapeutics
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
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Amla on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
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