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

Provident Clinical Research

Status: Completed

Conditions: Overweight; Obesity

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00692731

PRV-06001

Details and patient eligibility

About

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.

Full 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

Enrollment: 132 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

132 participants in 2 patient groups

Active

Description:

Tea catechin sport beverage

Treatment:

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

Control

Description:

Control beverage

Treatment:

Other: Control beverage matched for energy and caffeine content