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

Appetite and General Nutritional Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03031132
• Other study ID #: 2005823 HS
• Status: Suspended
• Phase: N/A
• First received: January 17, 2017
• Last updated: May 17, 2017
• Start date: June 2016
• Est. completion date: May 2018

Study information

• Verified date: May 2017
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 13
• Est. completion date: May 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 32 Years

Eligibility

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.

Related Conditions & MeSH terms

• Appetite and General Nutritional Disorders
• Nutrition Disorders

Intervention

Behavioral:
• HP-Beverage Breakfast
Participants will consume high protein beverage (shake) breakfast meals each morning.
• HP-Solid Breakfast
Participants will consume high protein solid (traditional food items) breakfast meals each morning.
• Breakfast Skipping
Participants will skip breakfast each morning.

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

References & Publications (47)

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* Note: There are 47 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hunger	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
Primary	Fullness	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
Primary	Prospective Food Consumption	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
Primary	Motivation to Eat	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
Primary	Hedonic Ratings (pleasure)	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
Secondary	Objective Sleep Status - Total Sleep Time	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
Secondary	Objective Sleep Quality	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
Secondary	Objective Sleep Efficiency	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
Secondary	Objective Sleep and Circadian Patterns - Salivary Cortisol	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
Secondary	Objective Sleep and Circadian Patterns - Salivary Melatonin	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
Secondary	Subjective Sleep Quality - Mood	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
Secondary	Subjective Sleep Quality - Energy	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
Secondary	Subjective Sleep Quality - Arousal	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
Secondary	Subjective Sleep Quality - Awakenings	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
Secondary	Functional Magnetic Resonance Imaging (fMRI) Brain Activation Responses	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
Secondary	Evening / Dinner Energy Intake - Calories	Energy intake during dinner and evening snacks of each testing day will be measured in calories consumed.	4 weeks
Secondary	Evening / Dinner Energy Intake - Macronutrients or food categories	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
Secondary	Evening / Dinner Energy Intake - Food Choice	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
Secondary	Appetite and Satiety Hormones (i.e., Ghrelin, PYY)	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