The Effects of a High Protein Breakfast on Appetite and Sleep in Young Adults
2017년 5월 17일 업데이트: 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.
연구 개요
상태
정지된
상세 설명
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.
연구 유형
중재적
등록 (실제)
13
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Missouri
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Columbia, Missouri, 미국, 65211
- University of Missouri
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
20년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hunger
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objective Sleep Status - Total Sleep Time
기간: 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
기간: 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 Efficiency
기간: 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 and Circadian Patterns - Salivary Cortisol
기간: 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 (cortisol).
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4 weeks
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Objective Sleep and Circadian Patterns - Salivary Melatonin
기간: 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
기간: 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
기간: 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
기간: 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 - Awakenings
기간: 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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Functional Magnetic Resonance Imaging (fMRI) Brain Activation Responses
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Heather J Leidy, PhD, Purdue University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2016년 6월 1일
기본 완료 (예상)
2017년 12월 1일
연구 완료 (예상)
2018년 5월 1일
연구 등록 날짜
최초 제출
2017년 1월 17일
QC 기준을 충족하는 최초 제출
2017년 1월 21일
처음 게시됨 (추정)
2017년 1월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 5월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 5월 17일
마지막으로 확인됨
2017년 5월 1일
추가 정보
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