Amla on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
NCT ID: NCT03633630
Last Updated: 2022-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
28 participants
INTERVENTIONAL
2019-04-01
2022-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Amla
Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days
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
Placebo
Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days
Interventions
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Amla
Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days
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 Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
30 Years
59 Years
ALL
No
Sponsors
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University of Guadalajara
OTHER
Responsible Party
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Esperanza Martínez-Abundis
Researcher Professor
Principal Investigators
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Esperanza Martínez-Abundis, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Experimental and Clinical Therapeutics
Locations
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Institute of Experimental and Clinical Therapeutics
Guadalajara, Jalisco, Mexico
Countries
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References
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Samson SL, Garber AJ. Metabolic syndrome. Endocrinol Metab Clin North Am. 2014 Mar;43(1):1-23. doi: 10.1016/j.ecl.2013.09.009.
Martinez-Abundis E, Mendez-Del Villar M, Perez-Rubio KG, Zuniga LY, Cortez-Navarrete M, Ramirez-Rodriguez A, Gonzalez-Ortiz M. Novel nutraceutic therapies for the treatment of metabolic syndrome. World J Diabetes. 2016 Apr 10;7(7):142-52. doi: 10.4239/wjd.v7.i7.142.
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Akhtar MS, Ramzan A, Ali A, Ahmad M. Effect of Amla fruit (Emblica officinalis Gaertn.) on blood glucose and lipid profile of normal subjects and type 2 diabetic patients. Int J Food Sci Nutr. 2011 Sep;62(6):609-16. doi: 10.3109/09637486.2011.560565. Epub 2011 Apr 18.
Cerezo C, Segura J, Praga M, Ruilope LM. Guidelines updates in the treatment of obesity or metabolic syndrome and hypertension. Curr Hypertens Rep. 2013 Jun;15(3):196-203. doi: 10.1007/s11906-013-0337-4.
Perez-Rubio KG, Gonzalez-Ortiz M, Martinez-Abundis E, Robles-Cervantes JA, Espinel-Bermudez MC. Effect of berberine administration on metabolic syndrome, insulin sensitivity, and insulin secretion. Metab Syndr Relat Disord. 2013 Oct;11(5):366-9. doi: 10.1089/met.2012.0183. Epub 2013 Jun 28.
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Mendez-Del Villar M, Gonzalez-Ortiz M, Martinez-Abundis E, Perez-Rubio KG, Cortez-Navarrete M. Effect of Irvingia gabonensis on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion. J Med Food. 2018 Jun;21(6):568-574. doi: 10.1089/jmf.2017.0092. Epub 2018 Jan 16.
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Other Identifiers
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Amla MS
Identifier Type: -
Identifier Source: org_study_id
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