Efficacy of a Tea Catechin Sports Drink for Enhancing Exercise-Induced Fat Loss
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| ClinicalTrials.gov Identifier: NCT00692731 |
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Recruitment Status :
Completed
First Posted : June 6, 2008
Last Update Posted : June 6, 2008
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| Condition or disease | Intervention/treatment |
|---|---|
| Overweight Obesity | Dietary Supplement: 500 mL/day of a beverage providing approximately 625 mg catechins Other: Control beverage matched for energy and caffeine content |
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 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 : | June 2006 |
| Actual Primary Completion Date : | July 2007 |
| Actual Study Completion Date : | August 2007 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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 |
- Changes in body fat mass. [ Time Frame: Baseline to end-of-treatment ]
- Changes in body weight [ Time Frame: Baseline to end-of-treatment ]
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| Ages Eligible for Study: | 21 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00692731
| 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: | Kevin C. Maki, PhD, Provident Clinical Research |
| ClinicalTrials.gov Identifier: | NCT00692731 |
| Other Study ID Numbers: |
PRV-06001 |
| First Posted: | June 6, 2008 Key Record Dates |
| Last Update Posted: | June 6, 2008 |
| Last Verified: | June 2008 |
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