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)

Adams-Huet B, Devaraj S, Siegel D, Jialal I. Increased adipose tissue insulin resistance in metabolic syndrome: relationship to circulating adipokines. Metab Syndr Relat Disord. 2014 Dec;12(10):503-7. doi: 10.1089/met.2014.0092. Epub 2014 Aug 27. — View Citation

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. — View Citation

Athyros VG, Mikhailidis DP. High incidence of metabolic syndrome further increases cardiovascular risk in patients with type 2 diabetes. Implications for everyday practice. J Diabetes Complications. 2016 Jan-Feb;30(1):9-11. doi: 10.1016/j.jdiacomp.2015.07.012. Epub 2015 Jul 17. — View Citation

Blaschke TF, Osterberg L, Vrijens B, Urquhart J. Adherence to medications: insights arising from studies on the unreliable link between prescribed and actual drug dosing histories. Annu Rev Pharmacol Toxicol. 2012;52:275-301. doi: 10.1146/annurev-pharmtox-011711-113247. Epub 2011 Sep 19. Review. — View Citation

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. Review. — View Citation

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. — View Citation

D'souza JJ, D'souza PP, Fazal F, Kumar A, Bhat HP, Baliga MS. Anti-diabetic effects of the Indian indigenous fruit Emblica officinalis Gaertn: active constituents and modes of action. Food Funct. 2014 Apr;5(4):635-44. doi: 10.1039/c3fo60366k. Review. — View Citation

Faizal P, Suresh S, Satheesh Kumar R, Augusti KT. A study on the hypoglycemic and hypolipidemic effects of an ayurvedic drug Rajanyamalakadi in diabetic patients. Indian J Clin Biochem. 2009 Jan;24(1):82-7. doi: 10.1007/s12291-009-0014-1. Epub 2009 May 8. — View Citation

Grundy SM. Pre-diabetes, metabolic syndrome, and cardiovascular risk. J Am Coll Cardiol. 2012 Feb 14;59(7):635-43. doi: 10.1016/j.jacc.2011.08.080. Review. — View Citation

Gutch M, Kumar S, Razi SM, Gupta KK, Gupta A. Assessment of insulin sensitivity/resistance. Indian J Endocrinol Metab. 2015 Jan-Feb;19(1):160-4. doi: 10.4103/2230-8210.146874. — View Citation

Harano Y, Suzuki M, Koyama Y, Kanda M, Yasuda S, Suzuki K, Takamizawa I. Multifactorial insulin resistance and clinical impact in hypertension and cardiovascular diseases. J Diabetes Complications. 2002 Jan-Feb;16(1):19-23. — View Citation

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

Nazish I, Ansari SH. Emblica officinalis - Anti-obesity activity. J Complement Integr Med. 2017 Dec 5;15(2). pii: /j/jcim.2018.15.issue-2/jcim-2016-0051/jcim-2016-0051.xml. doi: 10.1515/jcim-2016-0051. — View Citation

O'Neill S, O'Driscoll L. Metabolic syndrome: a closer look at the growing epidemic and its associated pathologies. Obes Rev. 2015 Jan;16(1):1-12. doi: 10.1111/obr.12229. Epub 2014 Nov 18. Review. — View Citation

Park SE, Park CY, Sweeney G. Biomarkers of insulin sensitivity and insulin resistance: Past, present and future. Crit Rev Clin Lab Sci. 2015;52(4):180-90. doi: 10.3109/10408363.2015.1023429. Epub 2015 Jun 4. Review. — View Citation

Patel SS, Goyal RK, Shah RS, Tirgar PR, Jadav PD. Experimental study on effect of hydroalcoholic extract of Emblica officinalis fruits on glucose homeostasis and metabolic parameters. Ayu. 2013 Oct;34(4):440-4. doi: 10.4103/0974-8520.127731. — View Citation

Pérez-Rubio KG, González-Ortiz M, Martínez-Abundis E, Robles-Cervantes JA, Espinel-Bermúdez 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. — View Citation

Ruilope LM, Nunes Filho ACB, Nadruz W Jr, Rodríguez Rosales FF, Verdejo-Paris J. Obesity and hypertension in Latin America: Current perspectives. Hipertens Riesgo Vasc. 2018 Apr - Jun;35(2):70-76. doi: 10.1016/j.hipert.2017.12.004. Epub 2018 Feb 1. Review. — View Citation

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. Review. — View Citation

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

Vasudeva N, Yadav N, Sharma SK. Natural products: a safest approach for obesity. Chin J Integr Med. 2012 Jun;18(6):473-80. doi: 10.1007/s11655-012-1120-0. Epub 2012 Jul 22. Review. — View Citation

Yang B, Liu P. Composition and biological activities of hydrolyzable tannins of fruits of Phyllanthus emblica. J Agric Food Chem. 2014 Jan 22;62(3):529-41. doi: 10.1021/jf404703k. Epub 2014 Jan 9. Review. — View Citation

Yokozawa T, Kim HY, Kim HJ, Okubo T, Chu DC, Juneja LR. Amla (Emblica officinalis Gaertn.) prevents dyslipidaemia and oxidative stress in the ageing process. Br J Nutr. 2007 Jun;97(6):1187-95. — View Citation

Zhang LZ, Zhao WH, Guo YJ, Tu GZ, Lin S, Xin LG. [Studies on chemical constituents in fruits of Tibetan medicine Phyllanthus emblica]. Zhongguo Zhong Yao Za Zhi. 2003 Oct;28(10):940-3. Chinese. — View Citation

* 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