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临床试验/NCT00692731
NCT00692731已完成不适用

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

Provident Clinical Research2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2006年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
132
试验地点
2
主要终点
Changes in body fat mass.

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Changes in body fat mass.

时间窗: Baseline to end-of-treatment

次要结局

  • Changes in body weight(Baseline to end-of-treatment)

研究者

发起方
Provident Clinical Research
申办方类型
Other

研究点 (2)

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