Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

The Effects of a High Protein Breakfast on Appetite and Sleep in Young Adults

17 mai 2017 mis à jour par: 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.

Aperçu de l'étude

Statut

Suspendu

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

13

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Missouri
      • Columbia, Missouri, États-Unis, 65211
        • University of Missouri

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

20 ans à 32 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: HP-Beverage Breakfast
Participants will consume high protein beverage (shake) breakfast meals each morning.
Expérimental: 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.
Comportemental: HP-Solid Breakfast
Participants will consume high protein solid (traditional food items) breakfast meals each morning.
Expérimental: 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.
Comportemental: Breakfast Skipping
Participants will skip breakfast each morning.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Hunger
Délai: 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."
4 weeks
Fullness
Délai: 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
Délai: 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
Motivation to Eat
Délai: 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
Hedonic Ratings (pleasure)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Objective Sleep Status - Total Sleep Time
Délai: 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 Quality
Délai: 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 Efficiency
Délai: 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
Délai: 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
Objective Sleep and Circadian Patterns - Salivary Melatonin
Délai: 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
Subjective Sleep Quality - Mood
Délai: 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 - Energy
Délai: 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 - Arousal
Délai: 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
Délai: 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
Délai: 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
Evening / Dinner Energy Intake - Calories
Délai: 4 weeks
Energy intake during dinner and evening snacks of each testing day will be measured in calories consumed.
4 weeks
Evening / Dinner Energy Intake - Macronutrients or food categories
Délai: 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
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Purdue University

Les enquêteurs

  • Chercheur principal: Heather J Leidy, PhD, Purdue University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juin 2016

Achèvement primaire (Anticipé)

1 décembre 2017

Achèvement de l'étude (Anticipé)

1 mai 2018

Dates d'inscription aux études

Première soumission

17 janvier 2017

Première soumission répondant aux critères de contrôle qualité

21 janvier 2017

Première publication (Estimation)

25 janvier 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 mai 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 mai 2017

Dernière vérification

1 mai 2017

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2005823 HS

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur HP-Beverage Breakfast

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Morocco

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements

3
S'abonner