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

This study has been completed.
Sponsor:
Collaborator:
Kao Corporation
Information provided by:
Provident Clinical Research
ClinicalTrials.gov Identifier:
NCT00692731
First received: June 4, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

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
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: 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

Resource links provided by NLM:


Further study details as provided by Provident Clinical Research:

Primary Outcome Measures:
  • Changes in body fat mass. [ Time Frame: Baseline to end-of-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in body weight [ Time Frame: Baseline to end-of-treatment ] [ Designated as safety issue: No ]

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
Active
Tea catechin sport beverage
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
Control
Control beverage
Other: Control beverage matched for energy and caffeine content
500 mL/day of a control beverage

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

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692731

Locations
United States, Florida
Meridien Research
St Petersburg, Florida, United States, 33709
United States, Indiana
Provident Clinical Research
Bloomington, Indiana, United States, 47403
Sponsors and Collaborators
Provident Clinical Research
Kao Corporation
Investigators
Study Director: Kevin C Maki, PhD Provident Clinical Research
  More Information

Publications:
Responsible Party: Kevin C. Maki, PhD, Provident Clinical Research
ClinicalTrials.gov Identifier: NCT00692731     History of Changes
Other Study ID Numbers: PRV-06001
Study First Received: June 4, 2008
Last Updated: June 4, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Provident Clinical Research:
green tea,
polyphenols,
weight loss,
body fat

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms
Epigallocatechin gallate
Anticarcinogenic Agents
Antimutagenic Agents
Antineoplastic Agents
Antioxidants
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014