NCT00871676已完成不适用
Use of Chewing Gum to Facilitate Appetite Control and Weight Loss in Overweight Individuals Treated by Lifestyle Modification
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Weight loss
研究概览
简要总结
This purpose of this study was to test the use of chewing gum as an adjunct to lifestyle modification to facilitate appetite control and weight loss in overweight and obese individuals.
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
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21-75 years of age
- •Body Mass Index of 25-45 inclusive
排除标准
- •major medical psychiatric conditions
- •medications know to effect weight
- •full or partial dentures
- •18 or fewer teeth
- •regular gum chewing (≥ 2 pieces/day)
- •use of any tobacco product
- •sensitivity to the following ingredients (mint, magnolia bark, eggs, or English Muffins)
- •history of PKU
- •sensitivity or allergy to aspartame
- •current/history of alcohol abuse or addiction (within 5 year)
- •recreational drug use
- •recent significant weight change (+/- 5% in previous 6 months)
- •currently pregnant or nursing and willingness not to get pregnant during course of study
- •participation in any other research studies
- •proximity to clinic (within one hour)
- •access to reliable transportation
研究组 & 干预措施
1
Active Comparator
Overweight/obese individuals being treated with lifestyle modification to facilitate weight loss.
干预措施: Lifestyle modification (Behavioral)
2
Experimental
Lifestyle modification plus use of chewing gum to facilitate weight loss in overweight/obese persons.
干预措施: Lifestyle modification plus gum (Behavioral)
结局指标
主要结局
Weight loss
时间窗: Week 16 and 52
次要结局
- Appetite control(Weeks 4, 8, 12, 16 and 52)
研究者
研究点 (1)
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