Effect of Green Tea Extract on Lipids in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— HDL  

Official title:

Effect of a 12-week Administration of Green Tea Extract on Lipids in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04532385
• Other study ID #: CUCS-INTEC-MV-TEVE-002
• Status: Completed
• Phase: N/A
• Start date: June 12, 2018
• Est. completion date: January 14, 2019

Study information

• Verified date: August 2020
• Source: Centro Universitario de Ciencias de la Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objectives of this study were to evaluate the effect of a 12-week supplementation with GTE (400 mg every 12 hours) on serum lipids, arterial stiffness and inflammatory cytokines in patients with T2DM.

Description:

A 12 week randomized double-blind, placebo-controlled trial was conducted in patients with T2DM to evaluate the effect of green tea extract (sunphenon 90D, TAIYO international, Minneapolis, US) at a 400 mg/12 hrs dose or calcined magnesia (400 mg/12 hrs) on lipids, anthropometric variables, arterial stiffness and inflammatory cytokines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 14, 2019
• Est. primary completion date: January 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with type 2 diabetes

Exclusion Criteria:

• Type 1 diabetes

• Smoking patients

• Ischemic heart disease

• Use of anti-inflammatory or antioxidant drugs

• Previously diagnosed liver or thyroid disease

Related Conditions & MeSH terms

• Arterial Stiffness
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Dyslipidemias

Intervention

Dietary Supplement:
• Green tea extract
400 mg capsule
• Placebo
400 mg capsule

Locations

Country	Name	City	State
Mexico	Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitario de Ciencias de la Salud, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (19)

Bogdanski P, Suliburska J, Szulinska M, Stepien M, Pupek-Musialik D, Jablecka A. Green tea extract reduces blood pressure, inflammatory biomarkers, and oxidative stress and improves parameters associated with insulin resistance in obese, hypertensive patients. Nutr Res. 2012 Jun;32(6):421-7. doi: 10.1016/j.nutres.2012.05.007. Epub 2012 Jun 20. — View Citation

Brown AL, Lane J, Coverly J, Stocks J, Jackson S, Stephen A, Bluck L, Coward A, Hendrickx H. Effects of dietary supplementation with the green tea polyphenol epigallocatechin-3-gallate on insulin resistance and associated metabolic risk factors: randomized controlled trial. Br J Nutr. 2009 Mar;101(6):886-94. doi: 10.1017/S0007114508047727. Epub 2008 Aug 19. — View Citation

Cox AJ, West NP, Cripps AW. Obesity, inflammation, and the gut microbiota. Lancet Diabetes Endocrinol. 2015 Mar;3(3):207-15. doi: 10.1016/S2213-8587(14)70134-2. Epub 2014 Jul 22. Review. — View Citation

Cui R, Yamagishi K, Muraki I, Hayama-Terada M, Umesawa M, Imano H, Li Y, Eshak ES, Ohira T, Kiyama M, Okada T, Kitamura A, Tanigawa T, Iso H; CIRCS investigators. Association between markers of arterial stiffness and atrial fibrillation in the Circulatory Risk in Communities Study (CIRCS). Atherosclerosis. 2017 Aug;263:244-248. doi: 10.1016/j.atherosclerosis.2017.06.918. Epub 2017 Jun 22. — View Citation

de Maat MP, Pijl H, Kluft C, Princen HM. Consumption of black and green tea had no effect on inflammation, haemostasis and endothelial markers in smoking healthy individuals. Eur J Clin Nutr. 2000 Oct;54(10):757-63. — View Citation

Gavish B, Izzo JL Jr. Arterial Stiffness: Going a Step Beyond. Am J Hypertens. 2016 Nov 1;29(11):1223-1233. doi: 10.1093/ajh/hpw061. — View Citation

Hsu CH, Tsai TH, Kao YH, Hwang KC, Tseng TY, Chou P. Effect of green tea extract on obese women: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2008 Jun;27(3):363-70. doi: 10.1016/j.clnu.2008.03.007. Epub 2008 May 12. — View Citation

Jeyaseelan L, Rao PS. Methods of determining sample sizes in clinical trials. Indian Pediatr. 1989 Feb;26(2):115-21. — View Citation

Kohara K, Tabara Y, Oshiumi A, Miyawaki Y, Kobayashi T, Miki T. Radial augmentation index: a useful and easily obtainable parameter for vascular aging. Am J Hypertens. 2005 Jan;18(1 Pt 2):11S-14S. — View Citation

Lessiani G, Santilli F, Boccatonda A, Iodice P, Liani R, Tripaldi R, Saggini R, Davì G. Arterial stiffness and sedentary lifestyle: Role of oxidative stress. Vascul Pharmacol. 2016 Apr;79:1-5. doi: 10.1016/j.vph.2015.05.017. Epub 2015 Jun 2. — View Citation

Liu CY, Huang CJ, Huang LH, Chen IJ, Chiu JP, Hsu CH. Effects of green tea extract on insulin resistance and glucagon-like peptide 1 in patients with type 2 diabetes and lipid abnormalities: a randomized, double-blinded, and placebo-controlled trial. PLoS One. 2014 Mar 10;9(3):e91163. doi: 10.1371/journal.pone.0091163. eCollection 2014. — View Citation

Marinovic MP, Morandi AC, Otton R. Green tea catechins alone or in combination alter functional parameters of human neutrophils via suppressing the activation of TLR-4/NF?B p65 signal pathway. Toxicol In Vitro. 2015 Oct;29(7):1766-78. doi: 10.1016/j.tiv.2015.07.014. Epub 2015 Jul 15. — View Citation

Onakpoya I, Spencer E, Heneghan C, Thompson M. The effect of green tea on blood pressure and lipid profile: a systematic review and meta-analysis of randomized clinical trials. Nutr Metab Cardiovasc Dis. 2014 Aug;24(8):823-36. doi: 10.1016/j.numecd.2014.01.016. Epub 2014 Jan 31. Review. — View Citation

Quezada-Fernández P, Trujillo-Quiros J, Pascoe-González S, Trujillo-Rangel WA, Cardona-Müller D, Ramos-Becerra CG, Barocio-Pantoja M, Rodríguez-de la Cerda M, Nérida Sánchez-Rodríguez E, Cardona-Muñóz EG, García-Benavides L, Grover-Páez F. Effect of green tea extract on arterial stiffness, lipid profile and sRAGE in patients with type 2 diabetes mellitus: a randomised, double-blind, placebo-controlled trial. Int J Food Sci Nutr. 2019 Dec;70(8):977-985. doi: 10.1080/09637486.2019.1589430. Epub 2019 May 14. — View Citation

Shirwany NA, Zou MH. Arterial stiffness: a brief review. Acta Pharmacol Sin. 2010 Oct;31(10):1267-76. doi: 10.1038/aps.2010.123. Epub 2010 Aug 30. Review. — View Citation

Stokes GS, Barin ES, Gilfillan KL. Effects of isosorbide mononitrate and AII inhibition on pulse wave reflection in hypertension. Hypertension. 2003 Feb;41(2):297-301. — View Citation

Virdis A, Taddei S. Endothelial Dysfunction in Resistance Arteries of Hypertensive Humans: Old and New Conspirators. J Cardiovasc Pharmacol. 2016 Jun;67(6):451-7. doi: 10.1097/FJC.0000000000000362. Review. — View Citation

Vlachopoulos C, Terentes-Printzios D, Ioakeimidis N, Rokkas K, Samentzas A, Aggelis A, Kardara D, Stefanadis C. Beneficial effect of vardenafil on aortic stiffness and wave reflections. J Clin Pharmacol. 2012 Aug;52(8):1215-21. doi: 10.1177/0091270011413586. Epub 2011 Sep 27. — View Citation

Zheng Y, Ley SH, Hu FB. Global aetiology and epidemiology of type 2 diabetes mellitus and its complications. Nat Rev Endocrinol. 2018 Feb;14(2):88-98. doi: 10.1038/nrendo.2017.151. Epub 2017 Dec 8. Review. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in cholesterol at week 12	Measured using the Erba Manheim XL-100 automatic chemistry analyzer	baseline and week 12
Primary	Change from baseline in HDL at week 12	Measured using the Erba Manheim XL-100 automatic chemistry analyzer	baseline and week 12
Primary	Change from baseline in LDL at week 12	Calculated using Friedewald's equation for LDL (LDL = cholesterol - HDL - triglycerides/5)	baseline and week 12
Primary	Change from baseline in triglycerides at week 12	Measured using the Erba Manheim XL-100 automatic chemistry analyzer	baseline and week 12
Primary	Change from baseline in VLDL at week 12	Calculated using Friedewald's equation for VLDL (VLDL = triglycerides/5)	baseline and week 12
Primary	Change from baseline in augmentation index at week 12	Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes	baseline and week 12
Primary	Change from baseline in pulse pressure at week 12	Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes	baseline and week 12
Primary	Change from baseline in central systolic blood pressure at week 12	Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes	baseline and week 12
Primary	Change from baseline in IL-6 at week 12	Measurement was done using commercially available ELISA kits from Peprotech	baseline and week 12
Primary	Change from baseline in IL-1ß at week 12	Measurement was done using commercially available ELISA kits from Peprotech	baseline and week 12
Primary	Change from baseline in TNF-a at week 12	Measurement was done using commercially available ELISA kits from Peprotech	baseline and week 12
Secondary	Change from baseline in glucose at week 12	Measured using the Erba Manheim XL-100 automatic chemistry analyzer	baseline and week 12
Secondary	Change from baseline in Hemoglobin A1c at week 12	Measured using the Bio-Rad Variant Classic Hemoglobin testing system	baseline and week 12
Secondary	Change from baseline in systolic blood pressure at week 12	Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes	baseline and week 12
Secondary	Change from baseline in diastolic blood pressure at week 12	Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes	baseline and week 12
Secondary	Change from baseline in IMC at week 12	Measured with the Tanita TBF-215 Body Composition Analyzer	baseline and week 12
Secondary	Change from baseline in body fat percentage at week 12	Measured with the Tanita TBF-215 Body Composition Analyzer	baseline and week 12
Secondary	Change from baseline in fat mass at week 12	Measured with the Tanita TBF-215 Body Composition Analyzer	baseline and week 12
Secondary	Change from baseline in lean mass at week 12	Measured with the Tanita TBF-215 Body Composition Analyzer	baseline and week 12
Secondary	Change from baseline in body water at week 12	Measured with the Tanita TBF-215 Body Composition Analyzer	baseline and week 12