The Effects of a High Protein Breakfast on Appetite and Sleep in Young Adults
NCT ID: NCT03031132
Last Updated: 2017-05-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
SUSPENDED
Clinical Phase
NA
Total Enrollment
13 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-06-30
Study Completion Date
2018-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Appetite and General Nutritional Disorders
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
HP-Beverage Breakfast
Intervention Type
BEHAVIORAL
Participants will consume high protein beverage (shake) breakfast meals each morning.
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.
Group Type
EXPERIMENTAL
HP-Solid Breakfast
Intervention Type
BEHAVIORAL
Participants will consume high protein solid (traditional food items) breakfast meals each morning.
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.
Group Type
EXPERIMENTAL
Breakfast Skipping
Intervention Type
BEHAVIORAL
Participants will skip breakfast each morning.
Interventions
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HP-Beverage Breakfast
Participants will consume high protein beverage (shake) breakfast meals each morning.
Intervention Type
BEHAVIORAL
HP-Solid Breakfast
Participants will consume high protein solid (traditional food items) breakfast meals each morning.
Intervention Type
BEHAVIORAL
Breakfast Skipping
Participants will skip breakfast each morning.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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
* 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
Minimum Eligible Age
20 Years
Maximum Eligible Age
32 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Purdue University
OTHER
Sponsor Role
lead
Responsible Party
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Heather Leidy
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Heather J Leidy, PhD
Role: PRINCIPAL_INVESTIGATOR
Purdue University
Locations
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University of Missouri
Columbia, Missouri, United States
Site Status
Countries
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United States
References
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Reference Type
DERIVED
Other Identifiers
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2005823 HS
Identifier Type: -
Identifier Source: org_study_id
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