Comparison of Low GI and High GI Potatoes in Relation to Satiety - a Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Subjective satiety evaluation
研究概览
简要总结
The study is a single-blind, randomised crossover study, investigating how a high glycaemic potato affects satiety in humans compared to a low glycaemic potato. This is done to shed further light on the discussion about whether potatoes with a high glycaemic index increases the risk of overweight and obesity and thus indirectly type 2 diabetes and cardiovascular disease.
详细描述
The POSAT study follows a single-blinded randomized crossover design. Each subject will have two separate intervention days with at least a six-day washout period in between. On the two intervention days the subjects will be randomized into receiving a breakfast containing isocaloric amounts of either low or high GI potatoes. VAS will be measured 5 minutes before the meal, immediately after the meal is consumed and in intervals of 30 minutes thereafter until 2,5 hours after the initial meal. After this the subjects will be served a standardized homogenous ad libitum meal. The amount of food consumed will be registered. The subjects will be asked to fast for 8-10 hours prior to the trial days and abstain from vigorous physical activity and alcohol consumption for 2 days prior to each trial day. The trial will be conducted over a total of 8 days with 5-6 study subjects pr. trial day. The trial days will be spread out over a total of 2 weeks to allow for a 1-week washout period between trial days for each subject.
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
- Single (Participant)
盲法说明
Subjets will not be aware of which test meal they will recieve first, and are not able to distinguish between the two potatoes.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men
- •Body mass index (BMI) 18-27 kg/m2
- •Age 18-40 years
- •Signed informed consent
- •Able to eat 500 grams of potato for breakfast
排除标准
- •Chronic diseases as diabetes, cardiovascular diseases or other chronic metabolic diseases, which could affect the results.
- •Use of daily prescription medicine (mild analgesics and antihistamines are allowed).
- •Use of medicine or dietary supplements that can affect ones appetite one month before the start of the study.
- •Smoking or have been smoking or using any nicotine products (gum or e-cigarette) within the last 3 months. Irregular smoking is allowed.
- •Elite athletes defined as doing >10 hours of strenuous physical activity per week.
- •Participation in other clinical studies <1 month before or during the study.
- •Inability, physically or psychologically, to comply with the procedures required by the study protocol. Judged by the investigators.
- •Any food allergies.
- •Weight change of ±3 kg from screening to the trial has been conducted.
- •Inability to complete the trial within 3 months after screening.
- •Unable to fast 8-10 hours before the trial days.
研究组 & 干预措施
A
Low glycaemic potato
干预措施: Low glycaemic potato (Other)
B
High glycaemic potato
干预措施: High glycaemic potato (Other)
结局指标
主要结局
Subjective satiety evaluation
时间窗: 3 hours
Visual Analogue Scale (100mm) filled out by subjects to describe satiety.
次要结局
- Energy consumed in Ad libitum meal(30 minutes)
- Hunger, fullness, and prospective food consumption(3 hours)
研究者
Anne Birgitte Raben
Professor
University of Copenhagen