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

June 4, 2008 updated by: Provident Clinical Research

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • St Petersburg, Florida, United States, 33709
        • Meridien Research
    • Indiana
      • Bloomington, Indiana, United States, 47403
        • Provident Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in body fat mass.
Time Frame: Baseline to end-of-treatment
Baseline to end-of-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in body weight
Time Frame: Baseline to end-of-treatment
Baseline to end-of-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Provident Clinical Research

Collaborators

Kao (Taiwan) Corporation

Investigators

  • Study Director: Kevin C Maki, PhD, Provident Clinical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

June 4, 2008

First Submitted That Met QC Criteria

June 4, 2008

First Posted (Estimate)

June 6, 2008

Study Record Updates

Last Update Posted (Estimate)

June 6, 2008

Last Update Submitted That Met QC Criteria

June 4, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRV-06001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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