Moderated-fat Diet Complemented With Green Tea Reduces oxLDL and Fat Mass in Obese Women (GTRoxLDL)

University of Guadalajara

Status and phase: Completed; Phase 4

Conditions: Nutritional and Metabolic Disease

Treatments: Other: Nutritional intervention; Dietary Supplement: Green tea

Study type: Interventional

Funder types: Other

Identifiers

NCT01628705

CI-10808

Details and patient eligibility

About

Background: Obesity is a chronic degenerative disease, considered as cardiovascular risk factor, characterized by systemic inflammation and high levels of oxLDL. Clinical studies have suggested that drink green tea could improve these complications.

Objective: Analyze the effect of a moderate-fat diet complemented with green tea on oxLDL, fat mass and TNFa in obese women.

Design: Randomized, controlled clinical trial. Obese women, without other chronic-degenerative disease were divided using a computer-generated random sequence: control group (CON) with n=32, and intervention group (INT) with n=32; and were instructed to consume a moderate-fat diet, and INT group was instructed to complement the diet with green tea. Anthropometric and biochemical measurements were performed, and oxLDL and TNFa s levels were determined by ELISA. All parameters were realized at baseline and in the 1st, 2nd and 3rd months post-intervention. TNFa mRNA expression was determined by real-time RT-PCR (basal and final). The changes on lipid profile, oxLDL, fat mass and TNFalpha expression were reported of the comparison between basal and final time points. The statistical analysis was performed with SPSS software.

Full description

The investigators assessed 114 women with the eligibility criteria: obese women older than 18y, in good health, as determined by a medical history questionnaire, and normal results of clinical laboratory tests excluding lipids. Exclusion criteria was: history of cardiovascular, hepatic, gastrointestinal, or renal disease; no alcoholism, no smoking, no exogenous hormone use or other medication; no supplemental vitamin or infusion drinking (tea, coffee); or treatment for weight loss 3 months before the start of the study. A total of 64 female, Mexican obese patients were included. We conducted the trial between April 2007 and December 2007 in Guadalajara, Jalisco, Mexico. All of the studies were conducted at Departamento de Biología Molecular en Medicina, Hospital Civil "Fray Antonio Alcalde". This study was approved by the Ethical Committee for Human Research, Universidad de Guadalajara (registration number 028/10). The procedures were in accordance with this institution's guidelines and written consent was obtained from each study subject.

Enrollment: 64 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• obese women older than 18 years,
• in good health, as determined by a medical history questionnaire, and
• normal results of clinical laboratory tests excluding lipids

Exclusion criteria

• history of cardiovascular, hepatic, gastrointestinal, or renal disease;
• no alcoholism, no smoking, no exogenous hormone use or other medication;
• no supplemental vitamin or infusion drinking (tea, coffee); or
• treatment for weight loss 3 months before the start of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Nutritional intervention

Sham Comparator group

Description:

The subjects were undergoing nutritional intervention.

Treatment:

Other: Nutritional intervention

Nutritional intervention with green tea

Experimental group

Description:

The subjects were undergoing nutritional intervention complemented with green tea.

Treatment:

Dietary Supplement: Green tea