The Effects of a High Protein Breakfast on Appetite and Sleep in Young Adults
17 maggio 2017 aggiornato da: 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.
Panoramica dello studio
Stato
Sospeso
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
13
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
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Missouri
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Columbia, Missouri, Stati Uniti, 65211
- University of Missouri
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 20 anni a 32 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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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Sperimentale: 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.
|
Participants will consume high protein solid (traditional food items) breakfast meals each morning.
|
|
Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Hunger
Lasso di tempo: 4 weeks
|
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
|
|
Fullness
Lasso di tempo: 4 weeks
|
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."
|
4 weeks
|
|
Prospective Food Consumption
Lasso di tempo: 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."
|
4 weeks
|
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Motivation to Eat
Lasso di tempo: 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."
|
4 weeks
|
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Hedonic Ratings (pleasure)
Lasso di tempo: 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."
|
4 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Objective Sleep Status - Total Sleep Time
Lasso di tempo: 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
Lasso di tempo: 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 Efficiency
Lasso di tempo: 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
|
|
Objective Sleep and Circadian Patterns - Salivary Cortisol
Lasso di tempo: 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).
|
4 weeks
|
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Objective Sleep and Circadian Patterns - Salivary Melatonin
Lasso di tempo: 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).
|
4 weeks
|
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Subjective Sleep Quality - Mood
Lasso di tempo: 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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Subjective Sleep Quality - Energy
Lasso di tempo: 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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Subjective Sleep Quality - Arousal
Lasso di tempo: 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
Lasso di tempo: 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
|
|
Functional Magnetic Resonance Imaging (fMRI) Brain Activation Responses
Lasso di tempo: 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.
|
4 weeks
|
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Evening / Dinner Energy Intake - Calories
Lasso di tempo: 4 weeks
|
Energy intake during dinner and evening snacks of each testing day will be measured in calories consumed.
|
4 weeks
|
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Evening / Dinner Energy Intake - Macronutrients or food categories
Lasso di tempo: 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
|
|
Evening / Dinner Energy Intake - Food Choice
Lasso di tempo: 4 weeks
|
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
|
|
Appetite and Satiety Hormones (i.e., Ghrelin, PYY)
Lasso di tempo: 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).
|
4 weeks
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Heather J Leidy, PhD, Purdue University
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 giugno 2016
Completamento primario (Anticipato)
1 dicembre 2017
Completamento dello studio (Anticipato)
1 maggio 2018
Date di iscrizione allo studio
Primo inviato
17 gennaio 2017
Primo inviato che soddisfa i criteri di controllo qualità
21 gennaio 2017
Primo Inserito (Stima)
25 gennaio 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
19 maggio 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
17 maggio 2017
Ultimo verificato
1 maggio 2017
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2005823 HS
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .