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

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ClinicalTrials.gov Identifier: NCT03031132
Recruitment Status : Suspended (Transferring study to another University)
First Posted : January 25, 2017
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
Heather Leidy, Purdue University

Tracking Information
First Submitted Date  ICMJE January 17, 2017
First Posted Date  ICMJE January 25, 2017
Last Update Posted Date May 19, 2017
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2017)
  • Hunger [ Time Frame: 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."
  • Fullness [ Time Frame: 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."
  • Prospective Food Consumption [ Time Frame: 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."
  • Motivation to Eat [ Time Frame: 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."
  • Hedonic Ratings (pleasure) [ Time Frame: 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."
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03031132 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2017)
  • Objective Sleep Status - Total Sleep Time [ Time Frame: 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.
  • Objective Sleep Quality [ Time Frame: 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.
  • Objective Sleep Efficiency [ Time Frame: 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.
  • Objective Sleep and Circadian Patterns - Salivary Cortisol [ Time Frame: 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).
  • Objective Sleep and Circadian Patterns - Salivary Melatonin [ Time Frame: 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).
  • Subjective Sleep Quality - Mood [ Time Frame: 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.
  • Subjective Sleep Quality - Energy [ Time Frame: 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.
  • Subjective Sleep Quality - Arousal [ Time Frame: 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.
  • Subjective Sleep Quality - Awakenings [ Time Frame: 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.
  • Functional Magnetic Resonance Imaging (fMRI) Brain Activation Responses [ Time Frame: 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.
  • Evening / Dinner Energy Intake - Calories [ Time Frame: 4 weeks ]
    Energy intake during dinner and evening snacks of each testing day will be measured in calories consumed.
  • Evening / Dinner Energy Intake - Macronutrients or food categories [ Time Frame: 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).
  • Evening / Dinner Energy Intake - Food Choice [ Time Frame: 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).
  • Appetite and Satiety Hormones (i.e., Ghrelin, PYY) [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of a High Protein Breakfast on Appetite and Sleep in Young Adults
Official Title  ICMJE The Effects of a High Protein Breakfast on Appetite and Sleep in Young Adults
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Appetite and General Nutritional Disorders
Intervention  ICMJE
  • Behavioral: HP-Beverage Breakfast
    Participants will consume high protein beverage (shake) breakfast meals each morning.
  • Behavioral: HP-Solid Breakfast
    Participants will consume high protein solid (traditional food items) breakfast meals each morning.
  • Behavioral: Breakfast Skipping
    Participants will skip breakfast each morning.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: HP-Beverage Breakfast
  • 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.
    Intervention: Behavioral: HP-Solid Breakfast
  • 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.
    Intervention: Behavioral: Breakfast Skipping
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Actual Enrollment  ICMJE
 (submitted: January 21, 2017)
13
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 32 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03031132
Other Study ID Numbers  ICMJE 2005823 HS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Heather Leidy, Purdue University
Study Sponsor  ICMJE Purdue University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Heather J Leidy, PhD Purdue University
PRS Account Purdue University
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP