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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ERIKA MARTINEZ-LOPEZ, University of Guadalajara
ClinicalTrials.gov Identifier:
NCT01628705
First received: May 17, 2012
Last updated: July 19, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Nutritional and Metabolic Disease
 Other: Nutritional intervention
Dietary Supplement: Green tea
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Moderated-fat Diet Complemented With Green Tea Reduces oxLDL and Fat Mass in Obese Women: A Randomized, Controlled Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Guadalajara:

Primary Outcome Measures:
  • Change in low density cholesterol [ Time Frame: Change from baseline in lipids, fat mass and TNF aplha levels at 3 months. ] [ Designated as safety issue: Yes ]
    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:
  • change in high density cholesterol [ Time Frame: baseline, 3 months ] [ Designated as safety issue: Yes ]
  • change in triglycerides [ Time Frame: baseline, 3 months ] [ Designated as safety issue: Yes ]
  • change in oxLDL [ Time Frame: baseline, 3 months ] [ Designated as safety issue: Yes ]
  • change in fat mass [ Time Frame: baseline, 3 months ] [ Designated as safety issue: Yes ]
  • change in TNF alpha levels [ Time Frame: baseline, 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 64
Study Start Date: April 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Nutritional intervention
The subjects were undergoing nutritional intervention.
 Other: Nutritional intervention

The subjects were undergoing nutritional intervention was reduced by 500 kcal per day of habitual caloric intake.

The proportion of daily intake of macronutrient in the moderate-fat diet was: 30% fat (saturated fat <7%, monounsaturated 10-15% and polyunsaturated 10%, respectively to total calories), 15% of protein, and 55% of carbohydrates. The dietary cholesterol was less than 200 mg/day, fiber intake was increased to 25 grams per day (50% soluble fiber).
Experimental: Nutritional intervention with green tea
The subjects were undergoing nutritional intervention complemented with green tea.
 Dietary Supplement: Green tea
The patients drank secha green tea. Subjects of the INT group were instructed on how to prepare the green tea infusion. Each cup was prepared using 3g of dried green tea in 300ml of hot water (temperature 80°C)for 4 min. It was drunk fresh and without sugar. The treatment consisted of 2 cup/day of green tea, one in the morning and one at night. The amount of epigallocathechin-3-gallate was 498mg/day.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628705

Locations
Mexico
University of Guadalajara
Guadalajara, Jaliscco, Mexico, 44280
Sponsors and Collaborators
University of Guadalajara
Investigators
Study Director: ERIKA MARTINEZ-LOPEZ, PhD University of Guadalajara
  More Information

No publications provided

Responsible Party: ERIKA MARTINEZ-LOPEZ, PhD, University of Guadalajara
ClinicalTrials.gov Identifier: NCT01628705     History of Changes
Other Study ID Numbers: CI-10808
Study First Received: May 17, 2012
Last Updated: July 19, 2012
Health Authority: Mexico: Ethics Committee

Keywords provided by University of Guadalajara:
Green tea
oxLDL
fat mass

Additional relevant MeSH terms:
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013