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

Phase 4

Completed

• Conditions: Nutritional and Metabolic Disease
• Interventions: Other: Nutritional intervention; Dietary Supplement: Green tea

• Registration Number: NCT01628705
• Lead Sponsor: University of Guadalajara

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2012-05-17
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-27
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-19
• Last Update Posted: 2012-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutritional intervention	Nutritional intervention	The subjects were undergoing nutritional intervention.
Nutritional intervention with green tea	Green tea	The subjects were undergoing nutritional intervention complemented with green tea.

Primary Outcome Measures

Name	Time	Method
Change in low density cholesterol	Change from baseline in lipids, fat mass and TNF aplha levels at 3 months.	Change in low density cholesterol, change in high density cholesterol, change in triglycerides, change in oxLDL and change in fat mass were assessed at the beginning and at each month during 3 months of intervention. Change in TNF alpha levels was assessed at the beginning and after 3 months. The final changes of all the measures were reported of the comparation between basal and after 3 months.

Secondary Outcome Measures

Name	Time	Method
change in TNF alpha levels	baseline, 3 months
change in high density cholesterol	baseline, 3 months
change in triglycerides	baseline, 3 months
change in oxLDL	baseline, 3 months
change in fat mass	baseline, 3 months

Trial Locations

Locations (1)

University of Guadalajara; 🇲🇽 Guadalajara, Jaliscco, Mexico