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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

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

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 Design

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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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Changes in body fat mass. [ Time Frame: Baseline to end-of-treatment ]

Secondary Outcome Measures :

1. Changes in body weight [ Time Frame: Baseline to end-of-treatment ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	21 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Murase T, Nagasawa A, Suzuki J, Hase T, Tokimitsu I. Beneficial effects of tea catechins on diet-induced obesity: stimulation of lipid catabolism in the liver. Int J Obes Relat Metab Disord. 2002 Nov;26(11):1459-64.

Dulloo AG, Duret C, Rohrer D, Girardier L, Mensi N, Fathi M, Chantre P, Vandermander J. Efficacy of a green tea extract rich in catechin polyphenols and caffeine in increasing 24-h energy expenditure and fat oxidation in humans. Am J Clin Nutr. 1999 Dec;70(6):1040-5.

Nagao T, Komine Y, Soga S, Meguro S, Hase T, Tanaka Y, Tokimitsu I. Ingestion of a tea rich in catechins leads to a reduction in body fat and malondialdehyde-modified LDL in men. Am J Clin Nutr. 2005 Jan;81(1):122-9.

Nagao T, Hase T, Tokimitsu I. A green tea extract high in catechins reduces body fat and cardiovascular risks in humans. Obesity (Silver Spring). 2007 Jun;15(6):1473-83.

Responsible Party:	Kevin C. Maki, PhD, Provident Clinical Research
ClinicalTrials.gov Identifier:	NCT00692731 History of Changes
Other Study ID Numbers:	PRV-06001
First Posted:	June 6, 2008
Last Update Posted:	June 6, 2008
Last Verified:	June 2008

Keywords provided by Provident Clinical Research:

green tea,; polyphenols,; weight loss,; body fat

Additional relevant MeSH terms:

Overweight; Body Weight; Signs and Symptoms; Caffeine; Epigallocatechin gallate; Central Nervous System Stimulants; Physiological Effects of Drugs; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action	Purinergic P1 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents; Antioxidants; Protective Agents; Antimutagenic Agents; Anticarcinogenic Agents; Antineoplastic Agents; Neuroprotective Agents