The Effects of a High Protein Breakfast on Appetite and Sleep in Young Adults
17 de maio de 2017 atualizado por: 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.
Visão geral do estudo
Status
Suspenso
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Intervencional
Inscrição (Real)
13
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Missouri
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Columbia, Missouri, Estados Unidos, 65211
- University of Missouri
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
20 anos a 32 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Experimental: 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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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Hunger
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Objective Sleep Status - Total Sleep Time
Prazo: 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
Prazo: 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
Prazo: 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 and Circadian Patterns - Salivary Cortisol
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Functional Magnetic Resonance Imaging (fMRI) Brain Activation Responses
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Heather J Leidy, PhD, Purdue University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de junho de 2016
Conclusão Primária (Antecipado)
1 de dezembro de 2017
Conclusão do estudo (Antecipado)
1 de maio de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
17 de janeiro de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de janeiro de 2017
Primeira postagem (Estimativa)
25 de janeiro de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de maio de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de maio de 2017
Última verificação
1 de maio de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2005823 HS
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em HP-Beverage Breakfast
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Fundació Institut de Recerca de l'Hospital de la...Programa de Reproducción Asistida F. Puigvert - HSCSPRescindidoSíndrome dos ovários policísticosEspanha
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HK inno.N CorporationAsan Medical CenterConcluído
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LG ChemConcluídoInfertilidade FemininaRepublica da Coréia
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DePuy InternationalConcluídoOsteoartrite | Artrite pós-traumática | Gota | PseudogotaSuíça, Itália
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Instituto Valenciano de Infertilidad, IVI VALENCIAConcluídoEstimulação ovarianaEspanha
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Universidade Federal do ParaConcluído
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Hospital de SabadellCorporacion Parc Tauli; Consorcio Centro de Investigación Biomédica en Red (CIBER)DesconhecidoHemorragia Úlcera PépticaEspanha
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Ferring PharmaceuticalsFerring SAUConcluído
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Ohio State UniversityConcluídoDiabetes | Síndrome metabólica | Medula espinhalEstados Unidos
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Shanghai Pudong HospitalConcluído