Effects of High-Fibre, Low-Energy Density Viscous Gel Meals on Satiety, Appetite Regulation and Subsequent Food Intake in Healthy Individuals
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Subjective Satiety
研究概览
简要总结
The purpose of this study is to assess whether low caloric, low energy density, konjac food products are effective in appetite regulation when administered as caloric replacements. It is hypothesized that replacement of typical, balanced, vegetarian meals with konjac food products will have comparable satiety scores, decreased postprandial glucose response, and will not significantly affect subsequent food intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, non-smoking males and females
- •Aged 18-70 years
- •BMI between 18 - 29.9 kg/m²
- •Non-dieters (1-10 score on Stunkard Eating Inventory)
排除标准
- •Known reported history of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyroid disease, Celiac disease/gastrointestinal disease, or AIDS
- •Weight change of +/- 3kg in the last 2 months
- •Alcohol intake >2 drinks/day
- •Inability to consume KJM-G meals
- •Any condition which might jeopardize the health and safety of the subject or study personnel, or adversely affect the study results
- •Non-compliance with experimental procedures or safety guidelines
研究组 & 干预措施
Konjac Glucomannan
650g KJM-G
干预措施: Konjac Glucomannan (Dietary Supplement)
Half Control/Half Konjac Glucomannan
325g KJM-G
干预措施: Konjac Glucomannan (Dietary Supplement)
Control
0g KJM-G
结局指标
主要结局
Subjective Satiety
时间窗: 12 hours for each of the 3 study visits.
Subjects will record their subjective satiety ratings using a 100 mm visual analogue scale and these ratings will be combined into a total subjective appetite score using the formula (Q1+Q2+(100-Q3)+Q4)/4.
次要结局
- Ambulatory Blood Pressure(Measured at the beginning of each of the 3 study visits and every 30 minutes thereafter until 10:00pm the same day.)
- Palatability Scores(Measured immediately after eating and finishing (<15min after the first bite) each meal (Breakfast, Lunch, Snack and Dinner) for each of the 3 study visits.)
- Subsequent Food Intake(Recorded from the 12th to the 24th hour after beginning the first meal (Breakfast at 0min) for each of the 3 study visits.)
- Height and Weight(Taken once at the beginning of each of the 3 clinical visits.)
- Blood Samples(One sample taken immediately prior to (0min) eating each meal (Breakfast, Lunch, Snack and Dinner) and at 30, 60, 90 and 120 min after eating the Breakfast and Lunch meals for each of the 3 study visits (total of 12 blood samples per study visit).)
- Food Craving Rating(Rated immediately prior (0min) to eating each meal (Breakfast, Lunch, Snack and Dinner) for each of the 3 study visits.)