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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GTE | Experimental | Green tea extract, 400 mg every 12 hours for 12 weeks |
|
| Placebo | Placebo Comparator | Calcined magnesia, 400 mg every 12 hours for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Green tea extract | Dietary Supplement | 400 mg capsule |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in cholesterol at week 12 | Measured using the Erba Manheim XL-100 automatic chemistry analyzer | baseline and week 12 |
| Change from baseline in HDL at week 12 | Measured using the Erba Manheim XL-100 automatic chemistry analyzer | baseline and week 12 |
| Change from baseline in LDL at week 12 | Calculated using Friedewald's equation for LDL (LDL = cholesterol - HDL - triglycerides/5) | baseline and week 12 |
| Change from baseline in triglycerides at week 12 | Measured using the Erba Manheim XL-100 automatic chemistry analyzer | baseline and week 12 |
| Change from baseline in VLDL at week 12 | Calculated using Friedewald's equation for VLDL (VLDL = triglycerides/5) | baseline and week 12 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in glucose at week 12 | Measured using the Erba Manheim XL-100 automatic chemistry analyzer | baseline and week 12 |
| Change from baseline in Hemoglobin A1c at week 12 | Measured using the Bio-Rad Variant Classic Hemoglobin testing system |
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Inclusion Criteria:
- Patients with type 2 diabetes
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara | Guadalajara | Jalisco | 44340 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29219149 | Background | 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. | |
| 27405964 | Background | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D013662 | Tea |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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patients were randomly assigned to receive green tea extract (sunphenon 90D, TAIYO international, Minneapolis, US) at a 400 mg/12 hrs dose or calcined magnesia (400 mg/12 hrs).
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An external pharmacy laboratory encapsulated the GTE and placebo, blinded and coded the study treatments.
| Placebo | Dietary Supplement | 400 mg capsule |
|
|
| 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 |
| Change from baseline in IL-6 at week 12 | Measurement was done using commercially available ELISA kits from Peprotech | baseline and week 12 |
| Change from baseline in IL-1β at week 12 | Measurement was done using commercially available ELISA kits from Peprotech | baseline and week 12 |
| Change from baseline in TNF-α at week 12 | Measurement was done using commercially available ELISA kits from Peprotech | baseline and week 12 |
| baseline and week 12 |
| 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 |
| 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 |
| Change from baseline in IMC at week 12 | Measured with the Tanita TBF-215 Body Composition Analyzer | baseline and week 12 |
| Change from baseline in body fat percentage at week 12 | Measured with the Tanita TBF-215 Body Composition Analyzer | baseline and week 12 |
| Change from baseline in fat mass at week 12 | Measured with the Tanita TBF-215 Body Composition Analyzer | baseline and week 12 |
| Change from baseline in lean mass at week 12 | Measured with the Tanita TBF-215 Body Composition Analyzer | baseline and week 12 |
| Change from baseline in body water at week 12 | Measured with the Tanita TBF-215 Body Composition Analyzer | baseline and week 12 |
| 20802505 | Background | 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. |
| 26044182 | Background | Lessiani G, Santilli F, Boccatonda A, Iodice P, Liani R, Tripaldi R, Saggini R, Davi 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. |
| 26808712 | Background | 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. |
| 11083483 | Background | 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. doi: 10.1038/sj.ejcn.1601084. |
| 12574098 | Background | 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. doi: 10.1161/01.hyp.0000049622.07021.4f. |
| 21953573 | Background | 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. |
| 2753525 | Background | Jeyaseelan L, Rao PS. Methods of determining sample sizes in clinical trials. Indian Pediatr. 1989 Feb;26(2):115-21. |
| 24614112 | Background | 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. |
| 15683726 | Background | 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. doi: 10.1016/j.amjhyper.2004.10.010. |
| 28683363 | Background | 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. |
| 18468736 | Background | 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. |
| 31084381 | Background | Quezada-Fernandez P, Trujillo-Quiros J, Pascoe-Gonzalez S, Trujillo-Rangel WA, Cardona-Muller D, Ramos-Becerra CG, Barocio-Pantoja M, Rodriguez-de la Cerda M, Nerida Sanchez-Rodriguez E, Cardona-Munoz EG, Garcia-Benavides L, Grover-Paez 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. |
| 18710606 | Background | 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. |
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| 26187476 | Background | 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/NFkappaB p65 signal pathway. Toxicol In Vitro. 2015 Oct;29(7):1766-78. doi: 10.1016/j.tiv.2015.07.014. Epub 2015 Jul 15. |
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| 25066177 | Background | 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. |
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |