Moderated-fat Diet Complemented With Green Tea Reduces oxLDL and Fat Mass in Obese Women (GTRoxLDL)
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|ClinicalTrials.gov Identifier: NCT01628705|
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : July 20, 2012
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 or disease||Intervention/treatment||Phase|
|Nutritional and Metabolic Disease||Other: Nutritional intervention Dietary Supplement: Green tea||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Moderated-fat Diet Complemented With Green Tea Reduces oxLDL and Fat Mass in Obese Women: A Randomized, Controlled Clinical Trial|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
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.
- Change in low density cholesterol [ Time Frame: 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.
- change in high density cholesterol [ Time Frame: baseline, 3 months ]
- change in triglycerides [ Time Frame: baseline, 3 months ]
- change in oxLDL [ Time Frame: baseline, 3 months ]
- change in fat mass [ Time Frame: baseline, 3 months ]
- change in TNF alpha levels [ Time Frame: baseline, 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628705
|University of Guadalajara|
|Guadalajara, Jaliscco, Mexico, 44280|
|Study Director:||ERIKA MARTINEZ-LOPEZ, PhD||University of Guadalajara|