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

NCT01628705 | Completed Phase 4 DMC

• 1 other identifier: CI-10808
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritional and Metabolic Disease

Keywords

Green tea; oxLDL; fat mass

Outcome Measures

Primary Outcomes (1)

• Change in low density cholesterol

  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 from baseline in lipids, fat mass and TNF aplha levels at 3 months.

Secondary Outcomes (5)

• 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

• change in TNF alpha levels

  baseline, 3 months

Study Arms (2)

Nutritional intervention

SHAM COMPARATOR

The subjects were undergoing nutritional intervention.

Other: Nutritional intervention

Nutritional intervention with green tea

EXPERIMENTAL

The subjects were undergoing nutritional intervention complemented with green tea.

Dietary Supplement: Green tea

Interventions

Nutritional intervention OTHER

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).

Nutritional intervention

Green tea DIETARY_SUPPLEMENT

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.

Nutritional intervention with green tea

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

University of Guadalajara

Guadalajara, Jaliscco, 44280, Mexico

Location

MeSH Terms

Conditions

Metabolic Diseases

Interventions

Tea

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• ERIKA MARTINEZ-LOPEZ, PhD

  University of Guadalajara

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: June 27, 2012
• Study Start: April 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 20, 2012

Record last verified: 2012-07

Locations

ME (1)