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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00692731
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : June 6, 2008
Sponsor:
Collaborator:
Kao Corporation
Information provided by:
Provident Clinical Research

Tracking Information
First Submitted Date June 4, 2008
First Posted Date June 6, 2008
Last Update Posted Date June 6, 2008
Study Start Date June 2006
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2008)
Changes in body fat mass. [ Time Frame: Baseline to end-of-treatment ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 4, 2008)
Changes in body weight [ Time Frame: Baseline to end-of-treatment ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Efficacy of a Tea Catechin Sports Drink for Enhancing Exercise-Induced Fat Loss
Official Title A Randomized, Double-Blind, Controlled Study to Assess the Efficacy of a Tea Catechin Sports Drink for Enhancing Exercise-Induced Fat Loss
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 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.
Condition
  • Overweight
  • Obesity
Intervention
  • 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
  • Other: Control beverage matched for energy and caffeine content
    500 mL/day of a control beverage
Study Groups/Cohorts
  • Active
    Tea catechin sport beverage
    Intervention: Dietary Supplement: 500 mL/day of a beverage providing approximately 625 mg catechins
  • Control
    Control beverage
    Intervention: Other: Control beverage matched for energy and caffeine content
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 4, 2008)
132
Original Actual Enrollment Same as current
Actual Study Completion Date August 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00692731
Other Study ID Numbers PRV-06001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kevin C. Maki, PhD, Provident Clinical Research
Study Sponsor Provident Clinical Research
Collaborators Kao Corporation
Investigators
Study Director: Kevin C Maki, PhD Provident Clinical Research
PRS Account Provident Clinical Research
Verification Date June 2008