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Sponsors and Collaborators: |
Provident Clinical Research Kao Corporation |
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Information provided by: | Provident Clinical Research |
ClinicalTrials.gov Identifier: | NCT00692731 |
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 | Intervention |
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Overweight Obesity |
Dietary Supplement: 500 mL/day of a beverage providing approximately 625 mg catechins Other: Control beverage matched for energy and caffeine content |
Study Type: | Observational |
Study Design: | Cohort, 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 |
Enrollment: | 132 |
Study Start Date: | June 2006 |
Study Completion Date: | August 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Active
Tea catechin sport beverage
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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
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Control
Control beverage
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Other: Control beverage matched for energy and caffeine content
500 mL/day of a control beverage
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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
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Subjects included generally healthy, normally sedentary men and women. Eligible participants were required to be 21 to 65 years of age, have a waist circumference ≥ 87 cm (women) or ≥ 90 cm (men), and total cholesterol ≥ 200 mg/dL at screening.
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Meridien Research | |
St Petersburg, Florida, United States, 33709 | |
United States, Indiana | |
Provident Clinical Research | |
Bloomington, Indiana, United States, 47403 |
Study Director: | Kevin C Maki, PhD | Provident Clinical Research |
Responsible Party: | Provident Clinical Research ( Kevin C. Maki, PhD ) |
Study ID Numbers: | PRV-06001 |
Study First Received: | June 4, 2008 |
Last Updated: | June 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00692731 |
Health Authority: | United States: Institutional Review Board |
green tea, polyphenols, weight loss, body fat |
Caffeine citrate Body Weight Epigallocatechin gallate Signs and Symptoms Obesity |
Weight Loss Nutrition Disorders Caffeine Overnutrition Overweight |