Amla on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03633630
• Other study ID #: Amla MS
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 1, 2019
• Est. completion date: March 30, 2022

Study information

• Verified date: November 2022
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 30, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Insulin Resistance
• Metabolic Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Mexico	Institute of Experimental and Clinical Therapeutics	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

References & Publications (30)

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Kim HY, Okubo T, Juneja LR, Yokozawa T. The protective role of amla (Emblica officinalis Gaertn.) against fructose-induced metabolic syndrome in a rat model. Br J Nutr. 2010 Feb;103(4):502-12. doi: 10.1017/S0007114509991978. Epub 2009 Nov 2. — View Citation

Krishnaveni M, Mirunalini S. Therapeutic potential of Phyllanthus emblica (amla): the ayurvedic wonder. J Basic Clin Physiol Pharmacol. 2010;21(1):93-105. Review. — View Citation

Lim S, Eckel RH. Pharmacological treatment and therapeutic perspectives of metabolic syndrome. Rev Endocr Metab Disord. 2014 Dec;15(4):329-41. doi: 10.1007/s11154-014-9298-4. Review. — View Citation

Martínez-Abundis E, Méndez-Del Villar M, Pérez-Rubio KG, Zuñiga LY, Cortez-Navarrete M, Ramírez-Rodriguez A, González-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. Review. — View Citation

Méndez-Del Villar M, González-Ortiz M, Martínez-Abundis E, Pérez-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. — View Citation

Nain P, Saini V, Sharma S, Nain J. Antidiabetic and antioxidant potential of Emblica officinalis Gaertn. leaves extract in streptozotocin-induced type-2 diabetes mellitus (T2DM) rats. J Ethnopharmacol. 2012 Jun 26;142(1):65-71. — View Citation

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Usharani P, Fatima N, Muralidhar N. Effects of Phyllanthus emblica extract on endothelial dysfunction and biomarkers of oxidative stress in patients with type 2 diabetes mellitus: a randomized, double-blind, controlled study. Diabetes Metab Syndr Obes. 2013 Jul 26;6:275-84. doi: 10.2147/DMSO.S46341. Print 2013. — View Citation

Variya BC, Bakrania AK, Patel SS. Emblica officinalis (Amla): A review for its phytochemistry, ethnomedicinal uses and medicinal potentials with respect to molecular mechanisms. Pharmacol Res. 2016 Sep;111:180-200. doi: 10.1016/j.phrs.2016.06.013. Epub 2016 Jun 15. Review. — View Citation

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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