A Prospective, Single Crossover, Randomized, Double Blind Placebo Controlled Trial Evaluating Subjective Ratings of Appetite and Glucoregulation of a Low Calorie Diet Supplemented With a High Viscosity Polysaccharide (PolyGlycopleX - PGX) vs. Rice Flour Control, in Overweight and Moderately Obese Females.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- Change in the ratings of the variables in the Appetite Visual Analog Scale and the overall Appetite Score.
研究概览
简要总结
The objective of the study is to compare subjective appetite ratings and after-meal and 24 hour blood glucose levels within overweight and obese female subjects consuming either a standardized 3 day low calorie diet supplemented with a viscous fibre known as PGX (treatment) or a rice flour (placebo control). Each treatment phase will be 3 days in length and separated by 3 week washout phase, so subjects will also be acting as their own control. Subjects will be randomized to either start with the low calorie diet with PGX or the low calorie diet supplemented with rice flour. We hypothesize that the 3 day LCD with PGX will elicit an improved appetite score compared to the 3 day LCD supplemented with the rice flour placebo control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 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
- •Known diabetes
- •Medications or natural health products that affect appetite
- •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)
5 grams of PGX 3 times per day with each main meal (breakfast, lunch and dinner)
干预措施: PolyGlycopleX (PGX) (Dietary Supplement)
Rice flour
5 grams of rice flour 3 times per day at each main meal (breakfast, lunch and dinner)
干预措施: PolyGlycopleX (PGX) (Dietary Supplement)
结局指标
主要结局
Change in the ratings of the variables in the Appetite Visual Analog Scale and the overall Appetite Score.
时间窗: 3 days
次要结局
- Changes in 2-hour postprandial areas under the curve (AUC) and 24 hour blood glucose (CGMS) profiles.(3 days)
