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

NCT04532385 | Completed

• 1 other identifier: CUCS-INTEC-MV-TEVE-002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2; Dyslipidemias; Arterial Stiffness

Outcome Measures

Primary Outcomes (11)

• 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

• 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

Secondary Outcomes (9)

• Change from baseline in glucose at week 12

  baseline and week 12

• Change from baseline in Hemoglobin A1c at week 12

  baseline and week 12

• Change from baseline in systolic blood pressure at week 12

  baseline and week 12

• Change from baseline in diastolic blood pressure at week 12

  baseline and week 12

• Change from baseline in IMC at week 12

  baseline and week 12

Study Arms (2)

GTE

EXPERIMENTAL

Green tea extract, 400 mg every 12 hours for 12 weeks

Dietary Supplement: Green tea extract

Placebo

PLACEBO COMPARATOR

Calcined magnesia, 400 mg every 12 hours for 12 weeks

Dietary Supplement: Placebo

Interventions

Green tea extract DIETARY_SUPPLEMENT

400 mg capsule

Also known as: Sunphenon 90D

GTE

Placebo DIETARY_SUPPLEMENT

400 mg capsule

Also known as: Calcined magnesia

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients with type 2 diabetes

You may not qualify if:

• Type 1 diabetes
• Smoking patients
• Ischemic heart disease
• Use of anti-inflammatory or antioxidant drugs
• Previously diagnosed liver or thyroid disease

Sponsors & Collaborators

• Centro Universitario de Ciencias de la Salud, Mexico: lead

Study Sites (1)

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (19)

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  PMID: 29219149 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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• 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.

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• 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.

  PMID: 26808712 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.

  PMID: 11083483 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.

  PMID: 12574098 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.

  PMID: 21953573 BACKGROUND

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

  PMID: 2753525 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.

  PMID: 24614112 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.

  PMID: 15683726 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.

  PMID: 28683363 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.

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• 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.

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• 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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• 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.

  PMID: 25066177 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Dyslipidemias

Interventions

Tea

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: An external pharmacy laboratory encapsulated the GTE and placebo, blinded and coded the study treatments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor Investigador Titular A

Model Details: 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).

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 31, 2020
• Study Start: June 12, 2018
• Primary Completion: January 14, 2019
• Study Completion: January 14, 2019
• Last Updated: August 31, 2020

Record last verified: 2020-08

Locations

ME (1)