The Effects of a High Protein Breakfast on Appetite and Sleep in Young Adults
2017年5月17日 更新者:Heather Leidy、Purdue University
The purpose of this study is to examine the effects of breakfast skipping (SKIP) vs. the consumption of a high protein solid (HP-S) breakfast vs. the consumption of a high protein beverage (HP-B) breakfast on daily appetite control, food cravings, food intake, and sleep quality in young adults.
研究概览
详细说明
Young adults will consume the following breakfasts (in randomized order) for 7 days/pattern: 350kcal HP breakfasts (30g protein) in solid or beverage form or will skip breakfast.
During the breakfast treatment periods, the participants will be provided with isocaloric breakfast meals containing 34% protein (30g protein), 40% CHO, and 26% fat.
The participants will consume these meals each day throughout each of the 7 day testing periods.
During the breakfast skipping treatment period, the participants will skip breakfast every morning with nothing to eat or drink (besides water) until 12:00 pm.
During the acclimation days (i.e., days 1-6), participants will eat their breakfasts at home or work or simply skip the morning meal.
An actigraph (to assess key indices of sleep) will be continuously worn and sleep diaries will be completed for all 7 testing days.
During the afternoon of Day 3, the participant will arrive at the University of Missouri-Physical Activity and Wellness Center (MU-PAW) and fitted with a Continuous Glucose Monitor (CGM) measure glycemic control over the next 3 days.
On day 6, the participant will complete hourly appetite questionnaires, consume a standardized dinner meal, and complete a salivary sample prior to sleep onset (sleep related hormones).
On the 7th day of each pattern, the participants will report to the MU-PAW in the morning to complete the respective testing day.
The participants will begin the testing day by either skipping breakfast or consuming their respective breakfast meal.
Blood samples, salivary samples, and assessments of perceived appetite will be collected/completed at specific times throughout the day.
Prior to lunch, a brain scan will be completed using functional magnetic resonance imaging (fMRI) to identify bain activation patterns in response to food pictures.
Following the fMRI, the participants will be provided with an a standardized lunch.
The participants will then complete the remainder of the testing day.
An ad libitum food buffet will be provided for the participants to consume after their departure at home throughout the remainder of the day. .
They will continue to wear the actigraph and eat/drink from the ad libitum packout cooler until going to bed that evening.
Lastly, participants will complete a salivary sample and sleep diary immediately before bed.
Between days 8-10, the participants will return all testing day equipment and the packout cooler, including all empty wrappers and any uneaten foods.
A 3-7 day washout period will occur between patterns in which the participant will return to their habitual (i.e.
pre-study) breakfast behaviors.
Study outcomes include morning, mid-day, afternoon, and evening appetite, satiety, pleasure, perceived energy/sleepiness, hormonal responses (plasma glucose, insulin, ghrelin, PYY, melatonin, and cortisol concentrations), sleep indices (i.e total sleep time, sleep efficiency, perceived sleep quality), brain activation patterns, evening energy intake, and daily energy intake.
研究类型
介入性
注册 (实际的)
13
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Missouri
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Columbia、Missouri、美国、65211
- University of Missouri
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 32年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- age 20-32y
- BMI 22-30kg/m2
- non-smoker, non-user of tobacco products
- generally healthy (as assessed by Medical History Questionnaire)
- right-handed (fMRI requirement)
- not pregnant or lactating in the past 6 months
- not clinically diagnosed with and eating disorder
- no metabolic, hormonal, and/or neural conditions/diseases/medications that influence metabolism or food intake
- no known bleeding disorders
- not currently or previously (In the past 6 months) on a weight loss or other special diet
- no weight loss/gain (>10lbs) in the past 6 months
- normal cognitive restraint, as assessed by a score of <4 on the Three Factors Eating Habits Questionnaire (TFEQ)
- rating of ≥ 5 illustrating a minimum of "neither like nor dislike" on a 9-point hedonic scale rating for the study breakfasts
- not clinically diagnosed with obstructive sleep apnea or insomnia and does not participate in shiftwork
Exclusion Criteria:
- The potential participants will be excluded if they do not meet the inclusion criteria.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:HP-Beverage Breakfast
For 7 days, the participants will consume high protein beverage breakfast meals each morning.
These meals will consist of shakes and will be 350 kcal.
The macronutrient composition of these meals will contain 30 g of dietary protein, 35g CHO, and 10g fat.
The HP-S and HP-B meals will be matched for energy density, sugar content, macronutrient content and types of proteins.
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Participants will consume high protein beverage (shake) breakfast meals each morning.
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实验性的:HP-Solid Breakfast
For 7 days, the participants will consume high protein solid breakfast meals each morning.
These meals will consist of traditional solid breakfast meals and will include commonly consumed breakfast foods (e.g., burritos, waffles, etc.) and will be 350 kcal.
The macronutrient composition of these meals will contain 30 g of dietary protein, 35 g CHO, and 10 g fat.
The HP-S and HP-B meals will be matched for energy density, sugar content, macronutrient content and types of proteins.
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Participants will consume high protein solid (traditional food items) breakfast meals each morning.
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实验性的:Breakfast Skipping
For 7 days, the participants will skip the morning meal.
No food or calorie-containing beverages will be consumed before 12pm on acclimation days and no food consumed until ~5h post habitual breakfast time on testing day 7.
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Participants will skip breakfast each morning.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Hunger
大体时间:4 weeks
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Questionnaires, assessing appetite sensations of hunger will be completed throughout each of the testing days (which are separated by 7-10 days).
The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response.
The questions are worded in the following manner "how strong is your feeling of" with anchors of "not all" to "extremely."
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4 weeks
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Fullness
大体时间:4 weeks
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Questionnaires, assessing appetite sensations of fullness will be completed throughout each of the testing days (which are separated by 7-10 days).
The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response.
The questions are worded in the following manner "how strong is your feeling of" with anchors of "not all" to "extremely."
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4 weeks
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Prospective Food Consumption
大体时间:4 weeks
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Questionnaires, assessing appetite sensations of prospective food consumption will be completed throughout each of the testing days (which are separated by 7-10 days).
The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response.
The questions are worded in the following manner "how strong is your feeling of" with anchors of "not all" to "extremely."
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4 weeks
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Motivation to Eat
大体时间:4 weeks
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Questionnaires, assessing appetite sensations of motivation to eat will be completed throughout each of the testing days (which are separated by 7-10 days).
The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response.
The questions are worded in the following manner "how strong is your feeling of" with anchors of "not all" to "extremely."
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4 weeks
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Hedonic Ratings (pleasure)
大体时间:4 weeks
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Questionnaires, assessing appetite sensations of hedonic pleasure will be completed throughout each of the testing days (which are separated by 7-10 days).
The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response.
The questions are worded in the following manner "how strong is your feeling of" with anchors of "not all" to "extremely."
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4 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Objective Sleep Status - Total Sleep Time
大体时间:4 weeks
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Indices of sleep status and habits will be assessed throughout the acclimation and testing days in each of the 3 study arms.
The participants will wear armband accelerometers / actigraphs to measure objective sleep parameters.
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4 weeks
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Objective Sleep Quality
大体时间:4 weeks
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Indices of sleep status and habits will be assessed throughout the acclimation and testing days in each of the 3 study arms.
The participants will wear armband accelerometers / actigraphs to measure objective sleep parameters.
|
4 weeks
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Objective Sleep Efficiency
大体时间:4 weeks
|
Indices of sleep status and habits will be assessed throughout the acclimation and testing days in each of the 3 study arms.
The participants will wear armband accelerometers / actigraphs to measure objective sleep parameters.
|
4 weeks
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Objective Sleep and Circadian Patterns - Salivary Cortisol
大体时间:4 weeks
|
Indices of sleep status and habits salivary sampling will be completed on days 6 and 7 of each study arm to assess sleep related hormones (cortisol).
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4 weeks
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Objective Sleep and Circadian Patterns - Salivary Melatonin
大体时间:4 weeks
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Indices of sleep status and habits salivary sampling will be completed on days 6 and 7 of each study arm to assess sleep related hormones (melatonin).
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4 weeks
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Subjective Sleep Quality - Mood
大体时间:4 weeks
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Indices of perceived sleep quality (mood, energy, arousal, awakenings) will be assessed throughout the acclimation and testing days in each of the 3 study arms.
The participants will complete bedtime and wake time sleep diaries to measure subjective sleep parameters.
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4 weeks
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Subjective Sleep Quality - Energy
大体时间:4 weeks
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Indices of perceived sleep quality (mood, energy, arousal, awakenings) will be assessed throughout the acclimation and testing days in each of the 3 study arms.
The participants will complete bedtime and wake time sleep diaries to measure subjective sleep parameters.
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4 weeks
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Subjective Sleep Quality - Arousal
大体时间:4 weeks
|
Indices of perceived sleep quality (mood, energy, arousal, awakenings) will be assessed throughout the acclimation and testing days in each of the 3 study arms.
The participants will complete bedtime and wake time sleep diaries to measure subjective sleep parameters.
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4 weeks
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Subjective Sleep Quality - Awakenings
大体时间:4 weeks
|
Indices of perceived sleep quality (mood, energy, arousal, awakenings) will be assessed throughout the acclimation and testing days in each of the 3 study arms.
The participants will complete bedtime and wake time sleep diaries to measure subjective sleep parameters.
|
4 weeks
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Functional Magnetic Resonance Imaging (fMRI) Brain Activation Responses
大体时间:4 weeks
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Brain activation responses will be assessed prior to lunch in each of the 3 testing days (separated by 2 weeks).
During the fMRI brain scan procedure, the participants will focus on a set of photographs which will be projected onto a screen and easily viewed through a mirror.
The fMRI paradigm incorporates stimuli from three categories of pictures including food, nonfood (animals), and blurred baseline images.
Brain activation in the Insula, Amygdala, Hippocampus, and Parahippocampus will be examined when viewing food vs. animal pictures.
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4 weeks
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Evening / Dinner Energy Intake - Calories
大体时间:4 weeks
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Energy intake during dinner and evening snacks of each testing day will be measured in calories consumed.
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4 weeks
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Evening / Dinner Energy Intake - Macronutrients or food categories
大体时间:4 weeks
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Energy intake during dinner and evening snacks of each testing day will be measured as macronutrient or food category (i.e.
amount of food consumed as protein, carbohydrates, fats, sugars, fiber).
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4 weeks
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Evening / Dinner Energy Intake - Food Choice
大体时间:4 weeks
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Energy intake during dinner and evening snacks of each testing day will be measured as types of foods consumed (i.e.
foods typically consumed as snacks, protein-rich foods, high carbohydrate/high fat convenience foods).
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4 weeks
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Appetite and Satiety Hormones (i.e., Ghrelin, PYY)
大体时间:4 weeks
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10 total blood samples will be drawn throughout each of the testing days (which are separated by 7-10 days).
Specifically, there will be seven 5 ml samples and three 9 ml samples; ~62 ml/testing day.
The samples will be collected in test tubes containing EDTA (ethylenediaminetetraacetic acid).
Protease inhibitors will be added to the sample to reduce protein degradation.
Samples will be centrifuged at -4°C for 10 minutes.
The plasma will then be separated and stored in microcentrifuge tubes at -80°C for future analysis.
Appetite related hormones will be measured (ex.
plasma total ghrelin and total PYY).
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4 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Heather J Leidy, PhD、Purdue University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年6月1日
初级完成 (预期的)
2017年12月1日
研究完成 (预期的)
2018年5月1日
研究注册日期
首次提交
2017年1月17日
首先提交符合 QC 标准的
2017年1月21日
首次发布 (估计)
2017年1月25日
研究记录更新
最后更新发布 (实际的)
2017年5月19日
上次提交的符合 QC 标准的更新
2017年5月17日
最后验证
2017年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
HP-Beverage Breakfast的临床试验
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Fundació Institut de Recerca de l'Hospital de la...Programa de Reproducción Asistida F. Puigvert - HSCSP终止
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Hospital de SabadellCorporacion Parc Tauli; Consorcio Centro de Investigación Biomédica en Red (CIBER)未知