Clinical trial NCT03031132: The Effects of a High Protein Breakfast on Appetite and Sleep in Young Adults
Official title: The Effects of a High Protein Breakfast on Appetite and Sleep in Young Adults
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Appetite and General Nutritional Disorders
Keywords: Protein-rich breakfast
Breakfast Skipping
Young Adults
Breakfast
Food form
fMRI
Ghrelin
PYY
Sleep
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hunger
timeFrame: 4 weeks
measure: Fullness
timeFrame: 4 weeks
measure: Prospective Food Consumption
timeFrame: 4 weeks
measure: Motivation to Eat
timeFrame: 4 weeks
measure: Hedonic Ratings (pleasure)
timeFrame: 4 weeks
Secondary outcomes:
measure: Objective Sleep Status - Total Sleep Time
timeFrame: 4 weeks
measure: Objective Sleep Quality
timeFrame: 4 weeks
measure: Objective Sleep Efficiency
timeFrame: 4 weeks
measure: Objective Sleep and Circadian Patterns - Salivary Cortisol
timeFrame: 4 weeks
measure: Objective Sleep and Circadian Patterns - Salivary Melatonin
timeFrame: 4 weeks
measure: Subjective Sleep Quality - Mood
timeFrame: 4 weeks
measure: Subjective Sleep Quality - Energy
timeFrame: 4 weeks
measure: Subjective Sleep Quality - Arousal
timeFrame: 4 weeks
measure: Subjective Sleep Quality - Awakenings
timeFrame: 4 weeks
measure: Functional Magnetic Resonance Imaging (fMRI) Brain Activation Responses
timeFrame: 4 weeks
measure: Evening / Dinner Energy Intake - Calories
timeFrame: 4 weeks
measure: Evening / Dinner Energy Intake - Macronutrients or food categories
timeFrame: 4 weeks
measure: Evening / Dinner Energy Intake - Food Choice
timeFrame: 4 weeks
measure: Appetite and Satiety Hormones (i.e., Ghrelin, PYY)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: Purdue University
name: Heather J Leidy, PhD
role: PRINCIPAL_INVESTIGATOR
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