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

Completed

• Conditions: Overweight; Obesity
• Interventions: Dietary Supplement: 500 mL/day of a beverage providing approximately 625 mg catechins; Other: Control beverage matched for energy and caffeine content

• Registration Number: NCT00692731
• Lead Sponsor: Provident Clinical Research

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.

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 Timeline

• Study Start: 2006-06
• Primary Completion: 2007-07
• Study Completion: 2007-08
• Status Verified: 2008-06
• Study First Submitted: 2008-06-04
• Study First Submitted QC: 2008-06-04
• Last Update Submitted: 2008-06-04
• Study First Posted: 2008-06-06
• Last Update Posted: 2008-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Exclusion Criteria

• Volunteers with Body mass index ≥ 40.0 kg/m2 or < 25.0 kg/m2;
• Recent weight loss of more than 4.5 kg;
• Recent use of any weight loss medications, supplements, or programs;
• History of weight-reducing surgery or an eating disorder
• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active	500 mL/day of a beverage providing approximately 625 mg catechins	Tea catechin sport beverage
Control	Control beverage matched for energy and caffeine content	Control beverage

Primary Outcome Measures

Name	Time	Method
Changes in body fat mass.	Baseline to end-of-treatment

Secondary Outcome Measures

Name	Time	Method
Changes in body weight	Baseline to end-of-treatment

Trial Locations

Locations (2)

Meridien Research; 🇺🇸 St Petersburg, Florida, United States

Provident Clinical Research; 🇺🇸 Bloomington, Indiana, United States