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临床试验/NCT00932750
NCT00932750已完成不适用

THE EFFECTS OF COFFEE MANNOOLIGOSACCHARIDES ON INDICES OF BODY WEIGHT, BODY COMPOSITION, AND SATIETY IN HUMANS

Mondelēz International, Inc.1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2006年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
82
试验地点
1
主要终点
Blood pressure

研究概览

简要总结

The goal of this study is to establish the role of coffee mannooligosaccharides (MOS), provided in a beverage format, on body weight regulation. Overweight and obese men and women will be randomized to one of 2 groups: placebo or MOS beverage. They will be required to consume 2 beverages/day for the duration of the 2 phases of the study. The MOS beverage will provide 2 g of MOS (total of 4 g/d). This dose level has been found to be well tolerated and safe. In the first phase, subjects will be counseled once monthly on a nutrition-related topic on an individual basis. They will be asked to maintain their regular eating and exercise habits for the duration of the 12 week period. An 8-week washout period will follow during which time they will not be required to consume the beverages. The second phase of the study will be a weight loss phase. For this phase, subjects will be re-randomized and may consume the alternate or the same beverage as the first phase, depending on the outcome of randomization. During this phase, they will undergo group counseling on a weekly basis. Counseling sessions will focus on weight loss and ways to achieve moderate weight loss of approximately 1-2 lbs/week. Measurements will be taken at the beginning and end of each phase. This study will allow us to determine whether MOS helps maintain body weight and prevent weight gain (first phase) and whether it helps to stimulate weight loss (second phase). The results will allow us to find ways in which overweight and obese individuals can incorporate beverages in their diets that will help promote weight loss.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Body mass index 27-33 kg/m2
  • Stable body weight

排除标准

  • Body width > 46 cm
  • Medications known to affect body weight, lipids, blood pressure
  • Pregnant or lactating women
  • Less than 1 y post-partum

结局指标

主要结局

Blood pressure

时间窗: Weekly

Body weight

时间窗: Weekly

Body Composition by Magnetic Resonance Imaging

时间窗: Baseline and Endpoint

Waist circumference

时间窗: Weekly

次要结局

  • Appetite/Satiety(Weekly)

研究者

发起方
Mondelēz International, Inc.
申办方类型
Industry

研究点 (1)

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