NCT01616251已完成不适用
Acute Effect of Animal and Vegetable Protein Rich Meals With Comparable Dietary Fibers Content on Appetite Sensation and Energy Intake
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Ad libitum energy intake
研究概览
简要总结
Background:
- New Nordic diet guidelines advocate a reduction in consumption of protein from animal sources such as beef and pork, due to environmental concerns.
- Instead, intake of protein from vegetable sources such as legumes and pulses should be increased.
- A previous study showed that a meal enriched with vegetable protein increased the subjective sensation of satiety and decreased hunger and ad libitum energy intake (EI) compared to animal protein.
- This study did, however, not document that vegetable protein per se is more satiating than animal protein as the vegetable meal had higher fiber content. Fiber is a likely confounder.
- The protein from egg is sparingly investigated in relation to appetite. Few studies have found that eggs have a high satiety index but further investigation is needed.
Objective:
- To examine if vegetable protein (beans and peas) can suppress subjective appetite (VAS and ad libitum energy intake) compared to isocaloric meals enriched with either red meat or egg with similar distribution of macronutrients and content of dietary fibers.
Design:
Single-blind randomized 4-way crossover meal study
Subjects:
33 young healthy men (Age: 18-50 years; BMI: 19-30 kg/m2). Expected completers: n=30.
End points:
- Subjective appetite (VAS) (every 30 min for 3 hours)
- Ad libitum EI (3 hours after lunch test meal)
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI: 18.5-30.0 kg/m2
- •Weight stable (within +/- 3 kg) two months prior to study inclusion,
- •Non-smoking
- •Nonathletic (< 10 h hard physical activity)
排除标准
- •BMI > 30 kg/m2
- •Change in smoking status
- •Daily or frequent use of medication that can affect appetite
- •Suffering from metabolic diseases
- •Suffering from psychiatric diseases
- •Suffering from any other clinical condition, which would make the subject unfit to participate in the study
- •alcohol and drug abuse
- •food allergies or relevance for the test meals
结局指标
主要结局
Ad libitum energy intake
时间窗: Measured on 4 separate test days in a crossover design. Each test day is separated by >1 week. Assessed 180 min after each of the 4 test meals.
180 min after each test meal an ad libitum meal of spaghetti bolognese is served, and the total energy intake is recorded.
次要结局
- Subjective appetite sensations (visual analogue scales) after ad libitum meal(Measured on 4 separate test days in a crossover design. Each test separated by >1 week. After completion of the ad libitum meal subjects will rate their subjective sensation of appetite (approx 3.5-h post intake of test meal))
- Acute 3-h changes from baseline in subjective appetite sensations using visual analogue scales(Measured on 4 separate test days in a crossover design. Each test day is separated by >1 week. On each test day appetite sensations are measured prior to the test meal (time 0) and 15, 30, 60, 90, 120, 150, 180 minutes post intake)
- Compensatory food intake (weighed dietary food record)(Measured on 4 separate test days in a crossover design. Each test separated by >1 week. Participants fill in a weighed food record from the time they complete the lunch until midnight.)
- Rating of the organoleptic quality of the test meals(Measured on 4 separate test days in a crossover design. Each test separated by >1 week. On each test day after completion of the test meal subjects will rate the test meal)
- Rating of the organoleptic quality of the ad libitum meal(Measured on 4 separate test days in a crossover design. Each test separated by >1 week. On each test day after completion of the ad libitum meal (approximately) time 15-20 minutes post intake) subjects will rate the ad libitum meal)
研究者
Arne Astrup
Professor, Dr Med
University of Copenhagen
研究点 (2)
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