Moderated-fat Diet Complemented With Green Tea Reduces oxLDL and Fat Mass in Obese Women: A Randomized, Controlled Clinical Trial
| Registry | NCT01628705, acronym GTRoxLDL |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 64 (Actual) |
| Sponsor | University of Guadalajara (Other) |
| Conditions | Nutritional and Metabolic Disease |
| Interventions | Nutritional intervention, Green tea (Other, dietary supplement) |
| Dates | start 2007-04-01, primary completion 2007-12-01, completion 2007-12-01, first posted 2012-06-27, last updated 2012-07-20 |
| Locations | 1 site in Mexico |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Nutritional and Metabolic Disease All trials of Nutritional intervention All trials of Green tea
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Nutritional intervention | Sham comparator | Other: Nutritional intervention | The subjects were undergoing nutritional intervention. |
| Nutritional intervention with green tea | Experimental | Dietary Supplement: Green tea | The subjects were undergoing nutritional intervention complemented with green tea. |
Sex: Female, ages: 18 Years to 60 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| University of Guadalajara | Guadalajara, Jaliscco | Mexico |