Obesity Clinical Trial
Official title:
A Randomized, Double-Blind, Controlled Study to Assess the Efficacy of a Tea Catechin Sports Drink for Enhancing Exercise-Induced Fat Loss
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.
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
;
Observational Model: Cohort, Time Perspective: Prospective
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