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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
13
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Missouri
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Columbia、Missouri、アメリカ、65211
- University of Missouri
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
20年～32年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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実験的：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hunger
時間枠：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
時間枠：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
時間枠：4 weeks
|
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
時間枠：4 weeks
|
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)
時間枠：4 weeks
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Objective Sleep Status - Total Sleep Time
時間枠：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.
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4 weeks
|
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Objective Sleep Quality
時間枠：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.
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4 weeks
|
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Objective Sleep Efficiency
時間枠：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
時間枠：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
時間枠：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 (melatonin).
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4 weeks
|
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Subjective Sleep Quality - Mood
時間枠：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 - Energy
時間枠：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 - Arousal
時間枠：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
|
|
Subjective Sleep Quality - Awakenings
時間枠：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
時間枠：4 weeks
|
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
時間枠：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
時間枠：4 weeks
|
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).
|
4 weeks
|
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Evening / Dinner Energy Intake - Food Choice
時間枠：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).
|
4 weeks
|
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Appetite and Satiety Hormones (i.e., Ghrelin, PYY)
時間枠：4 weeks
|
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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Heather J Leidy, PhD、Purdue University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2016年6月1日
一次修了 (予想される)
2017年12月1日
研究の完了 (予想される)
2018年5月1日
試験登録日
最初に提出
2017年1月17日
QC基準を満たした最初の提出物
2017年1月21日
最初の投稿 (見積もり)
2017年1月25日
学習記録の更新
投稿された最後の更新 (実際)
2017年5月19日
QC基準を満たした最後の更新が送信されました
2017年5月17日
最終確認日
2017年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。