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

Obesity Clinical Trial

Official title:

A Randomized, Double-Blind, Controlled Study to Assess the Efficacy of a Tea Catechin Sports Drink for Enhancing Exercise-Induced Fat Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692731
• Other study ID #: PRV-06001
• Status: Completed
• Phase: N/A
• First received: June 4, 2008
• Last updated: June 4, 2008
• Start date: June 2006
• Est. completion date: August 2007

Study information

• Verified date: June 2008
• Source: Provident Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: August 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity
• Overweight

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

Locations

Country	Name	City	State
United States	Provident Clinical Research	Bloomington	Indiana
United States	Meridien Research	St Petersburg	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Provident Clinical Research	Kao Corporation

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in body fat mass.		Baseline to end-of-treatment	No
Secondary	Changes in body weight		Baseline to end-of-treatment	No