Clinical trial NCT00692731: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight
Obesity
Keywords: green tea,
polyphenols,
weight loss,
body fat
Lead sponsor: Provident Clinical Research
Sponsor class: OTHER
Collaborators: name: Kao (Taiwan) Corporation
First posted: 2008-06-06
Enrollment: 132
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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

Primary outcomes:
measure: Changes in body fat mass.
timeFrame: Baseline to end-of-treatment
Secondary outcomes:
measure: Changes in body weight
timeFrame: Baseline to end-of-treatment
Other outcomes:
Locations:
city: St Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Bloomington
country: United States
facility: Provident Clinical Research
state: Indiana
Study officials:
affiliation: Provident Clinical Research
name: Kevin C Maki, PhD
role: STUDY_DIRECTOR
References:
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. doi: 10.1038/sj.ijo.0802141.
citation: 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. doi: 10.1093/ajcn/70.6.1040.
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. doi: 10.1093/ajcn/81.1.122.
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. doi: 10.1038/oby.2007.176.