Efficacy of a Tea Catechin Sports Drink for Enhancing Exercise-Induced Fat Loss

Sponsor

Provident Clinical Research (Other)

Overall Status

Completed

CT.gov ID

NCT00692731

Collaborator

Kao (Taiwan) Corporation (Industry)

132

Enrollment

Locations

Duration (Months)

Patients Per Site

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this trial is to evaluate the influence of consuming a tea catechin containing sports beverage on body fat mass during exercise-induced weight loss among overweight and obese men and women.

Condition or Disease	Intervention/Treatment	Phase
Overweight Obesity	Dietary Supplement: 500 mL/day of a beverage providing approximately 625 mg catechins Other: Control beverage matched for energy and caffeine content

Detailed Description

The study will include two screening/baseline visits and six treatment visits over 12 weeks. During the treatment phase of the study, subjects will be instructed to consume one bottle of sports drink (500 ml) daily (total consumption of tea catechins in the active group = 540 mg/d). Subjects will be asked to maintain a constant energy intake throughout the study period. Three-day diet records will be collected and analyzed at weeks 0, 6, and 12 to evaluate consistency of energy intake.

All subjects will engage in an exercise program with a goal of maintaining 180 min/week of low- to moderate-intensity exercise (e.g., walking and other aerobic activities, 4-6 days per week). Three of the weekly exercise sessions will be supervised and 1-3 will be unsupervised. Subjects will be asked to wear a pedometer and record their daily physical activity (steps) each night in a physical activity diary. Diaries will be collected at each visit and used to evaluate exercise compliance. Dual energy X-ray absorptiometry (DEXA) and computed tomography (CT) scans will be performed at baseline (week 0) and at the end of the treatment (week 12). Additionally, body weight and abdominal circumference will be assessed at every clinic visit during the study. It is anticipated that subjects will expend 1000-1800 kcal per week above their baseline level in deliberate physical activity. Accordingly, the control group is expected to lose 1.5 to 2.8 kg of body fat during the 12-week treatment period

Study Design

Study Type:

Observational

Actual Enrollment :

132 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Randomized, Double-Blind, Controlled Study to Assess the Efficacy of a Tea Catechin Sports Drink for Enhancing Exercise-Induced Fat Loss

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Tea catechin sport beverage	Dietary Supplement: 500 mL/day of a beverage providing approximately 625 mg catechins Subjects were asked to consume 500 mL/day of a beverage providing approximately 625 mg catechins
Control Control beverage	Other: Control beverage matched for energy and caffeine content 500 mL/day of a control beverage

Arm

Intervention/Treatment

Active

Tea catechin sport beverage

Dietary Supplement: 500 mL/day of a beverage providing approximately 625 mg catechins

Subjects were asked to consume 500 mL/day of a beverage providing approximately 625 mg catechins

Control

Control beverage

Other: Control beverage matched for energy and caffeine content

500 mL/day of a control beverage

Outcome Measures

Primary Outcome Measures

Changes in body fat mass. [Baseline to end-of-treatment]

Secondary Outcome Measures

Changes in body weight [Baseline to end-of-treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Men and women 21 to 65 years of age, inclusive
Waist circumference ≥ 87 cm for women and ≥ 90 cm for men at screening
Total cholesterol ≥ 200 mg/dL
Provide written informed consent and authorization for protected health information