NCT01109199已完成3 期
A Randomized, Double Blind, Placebo Controlled Trial Evaluating the Effects of a High Viscosity Dietary Fibre (PGX) Supplementation of a Low Calorie Diet on Appetite and Body Weight, in Overweight and Moderately Obese Females
Canadian Center for Functional Medicine2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The difference in appetite score assessed from appetite Visual Analog Scale
研究概览
简要总结
This 18 week, randomized, double blind, placebo controlled trial will examine the effects of thick dietary fibre (PGX) supplementation of a low calorie diet (LCD) on appetite, weight loss, body composition, and compliance in overweight and moderately obese female.
The investigators believe that 15 grams/day PGX supplementation of a low calorie diet over a 14-weeks period will elicit a better appetite score (e.g. reduced hunger) compared to the rice flour supplementation of the LCD.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI 25 - 35 Kg/m2
排除标准
- •Medications and supplements that affect appetite
- •Known diabetes
- •Contraindications to LCD
- •Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the protocol.
研究组 & 干预措施
PolyGlycopleX (PGX)
Experimental
干预措施: PolyGlycopleX (PGX) (Dietary Supplement)
Rice Flour
Placebo Comparator
干预措施: Rice flour (Dietary Supplement)
结局指标
主要结局
The difference in appetite score assessed from appetite Visual Analog Scale
时间窗: 18 weeks
次要结局
- Change in weight (kilograms)(18 weeks)
- Change in percentage of body fat(18 weeks)
研究者
研究点 (2)
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