Appetite and General Nutritional DisordersNCT03031132
The Effects of a High Protein Breakfast on Appetite and Sleep in Young Adults
A study testing HP-Beverage Breakfast, HP-Solid Breakfast and Breakfast Skipping in people with Appetite and General Nutritional Disorders, run by Purdue University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite and General Nutritional Disorders
- What is being tested?
- HP-Beverage Breakfast, HP-Solid Breakfast and Breakfast Skipping
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- The potential participants will be excluded if they do not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- HP-Beverage Breakfast, HP-Solid Breakfast, Breakfast Skipping
- Keywords
- Protein-rich breakfast, Breakfast Skipping, Young Adults, Breakfast, Food form, fMRI, Ghrelin, PYY, Sleep
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HP-Beverage BreakfastBehavioural
Participants will consume high protein beverage (shake) breakfast meals each morning.
HP-Solid BreakfastBehavioural
Participants will consume high protein solid (traditional food items) breakfast meals each morning.
Breakfast SkippingBehavioural
Participants will skip breakfast each morning.
| Study group | Role | What they receive |
|---|---|---|
| HP-Beverage Breakfast | Experimental | 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. Receives: Behavioral: HP-Beverage Breakfast |
| HP-Solid Breakfast | Experimental | 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. Receives: Behavioral: HP-Solid Breakfast |
| Breakfast Skipping | Experimental | 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. Receives: Behavioral: Breakfast Skipping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 4 weeks
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."
Measured: 4 weeks
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."
Measured: 4 weeks
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."
Measured: 4 weeks
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."
Measured: 4 weeks
Secondary outcomes (14)
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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).
Measured: 4 weeks
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).
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Evening / Dinner Energy Intake - Calories
Energy intake during dinner and evening snacks of each testing day will be measured in calories consumed.
Measured: 4 weeks
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).
Measured: 4 weeks
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).
Measured: 4 weeks
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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startJun 2016
- Primary completionDec 2017 (estimated)
- Study completionMay 2018 (estimated)
Why it stopped: Transferring study to another University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Appetite and General Nutritional DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Leidy, Purdue University
- Investigators
- Heather J Leidy, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031132
- Sponsor's protocol ID
- 2005823 HS
- Status last verified
- May 2017
- First submitted
- 17 Jan 2017
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
PubMed 24570244Deshmukh-Taskar PR, Nicklas TA, O'Neil CE, Keast DR, Radcliffe JD, Cho S. The relationship of breakfast skipping and type of breakfast consumption with nutrient intake and weight status in children and adolescents: the National Health and Nutrition Examination Survey 1999-2006. J Am Diet Assoc. 2010 Jun;110(6):869-78. doi: 10.1016/j.jada.2010.03.023.
PubMed 20497776Nicklas TA, Yang SJ, Baranowski T, Zakeri I, Berenson G. Eating patterns and obesity in children. The Bogalusa Heart Study. Am J Prev Med. 2003 Jul;25(1):9-16. doi: 10.1016/s0749-3797(03)00098-9.
PubMed 12818304Piernas C, Popkin BM. Trends in snacking among U.S. children. Health Aff (Millwood). 2010 Mar-Apr;29(3):398-404. doi: 10.1377/hlthaff.2009.0666.
PubMed 20194979Duffey KJ, Popkin BM. Energy density, portion size, and eating occasions: contributions to increased energy intake in the United States, 1977-2006. PLoS Med. 2011 Jun;8(6):e1001050. doi: 10.1371/journal.pmed.1001050. Epub 2011 Jun 28.
PubMed 21738451Hammons AJ, Fiese BH. Is frequency of shared family meals related to the nutritional health of children and adolescents? Pediatrics. 2011 Jun;127(6):e1565-74. doi: 10.1542/peds.2010-1440. Epub 2011 May 2.
PubMed 21536618Council on Communications and Media; Strasburger VC. Children, adolescents, obesity, and the media. Pediatrics. 2011 Jul;128(1):201-8. doi: 10.1542/peds.2011-1066. Epub 2011 Jun 27.
PubMed 21708800Garcia G, Sunil TS, Hinojosa P. The fast food and obesity link: consumption patterns and severity of obesity. Obes Surg. 2012 May;22(5):810-8. doi: 10.1007/s11695-012-0601-8.
PubMed 22271359Moag-Stahlberg, A. 2010 ADAF Family nutrition and physical activity survey background data. 2010; Available from: www.Eatright.org.
Brown AW, Bohan Brown MM, Allison DB. Belief beyond the evidence: using the proposed effect of breakfast on obesity to show 2 practices that distort scientific evidence. Am J Clin Nutr. 2013 Nov;98(5):1298-308. doi: 10.3945/ajcn.113.064410. Epub 2013 Sep 4.
PubMed 24004890Leidy HJ, Clifton PM, Astrup A, Wycherley TP, Westerterp-Plantenga MS, Luscombe-Marsh ND, Woods SC, Mattes RD. The role of protein in weight loss and maintenance. Am J Clin Nutr. 2015 Jun;101(6):1320S-1329S. doi: 10.3945/ajcn.114.084038. Epub 2015 Apr 29.
PubMed 25926512Leidy HJ, Racki EM. The addition of a protein-rich breakfast and its effects on acute appetite control and food intake in 'breakfast-skipping' adolescents. Int J Obes (Lond). 2010 Jul;34(7):1125-33. doi: 10.1038/ijo.2010.3. Epub 2010 Feb 2.
PubMed 20125103Leidy HJ, Lepping RJ, Savage CR, Harris CT. Neural responses to visual food stimuli after a normal vs. higher protein breakfast in breakfast-skipping teens: a pilot fMRI study. Obesity (Silver Spring). 2011 Oct;19(10):2019-25. doi: 10.1038/oby.2011.108. Epub 2011 May 5.
PubMed 21546927Leidy HJ, Ortinau LC, Douglas SM, Hoertel HA. Beneficial effects of a higher-protein breakfast on the appetitive, hormonal, and neural signals controlling energy intake regulation in overweight/obese, "breakfast-skipping," late-adolescent girls. Am J Clin Nutr. 2013 Apr;97(4):677-88. doi: 10.3945/ajcn.112.053116. Epub 2013 Feb 27.
PubMed 23446906Hoertel HA, Will MJ, Leidy HJ. A randomized crossover, pilot study examining the effects of a normal protein vs. high protein breakfast on food cravings and reward signals in overweight/obese "breakfast skipping", late-adolescent girls. Nutr J. 2014 Aug 6;13:80. doi: 10.1186/1475-2891-13-80.
PubMed 25098557
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a High Protein Breakfast on Appetite and Sleep in Young Adults
- ClinicalTrials.gov ID
- NCT03031132
- Acronym / sponsor ID
- 2005823 HS
- Keywords
- Protein-rich breakfast, Breakfast Skipping, Young Adults, Breakfast, Food form, fMRI, Ghrelin, PYY
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Transferring study to another University
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 25 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HP-Beverage Breakfast | Experimental | Behavioral: HP-Beverage BreakfastFor 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. |
| HP-Solid Breakfast | Experimental | Behavioral: HP-Solid BreakfastFor 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. |
| Breakfast Skipping | Experimental | Behavioral: Breakfast SkippingFor 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. |
Who may qualify
- Ages
- 20 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (1 listed)
- The potential participants will be excluded if they do not meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HP-Beverage BreakfastParticipants will consume high protein beverage (shake) breakfast meals each morning. | Behavioural | HP-Beverage Breakfast |
| HP-Solid BreakfastParticipants will consume high protein solid (traditional food items) breakfast meals each morning. | Behavioural | HP-Solid Breakfast |
| Breakfast SkippingParticipants will skip breakfast each morning. | Behavioural | Breakfast Skipping |
Primary outcome
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."
14 secondary outcomes
Objective Sleep Status - Total Sleep Time
Time frame: 4 weeks
Objective Sleep Quality
Time frame: 4 weeks
Objective Sleep Efficiency
Time frame: 4 weeks
Objective Sleep and Circadian Patterns - Salivary Cortisol
Time frame: 4 weeks
Objective Sleep and Circadian Patterns - Salivary Melatonin
Time frame: 4 weeks
Subjective Sleep Quality - Mood
Time frame: 4 weeks
Subjective Sleep Quality - Energy
Time frame: 4 weeks
Subjective Sleep Quality - Arousal
Time frame: 4 weeks
Subjective Sleep Quality - Awakenings
Time frame: 4 weeks
Functional Magnetic Resonance Imaging (fMRI) Brain Activation Responses
Time frame: 4 weeks
Evening / Dinner Energy Intake - Calories
Time frame: 4 weeks
Evening / Dinner Energy Intake - Macronutrients or food categories
Time frame: 4 weeks
Evening / Dinner Energy Intake - Food Choice
Time frame: 4 weeks
Appetite and Satiety Hormones (i.e., Ghrelin, PYY)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Background: PubMed 24570244Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
- Background: PubMed 20497776Deshmukh-Taskar PR, Nicklas TA, O'Neil CE, Keast DR, Radcliffe JD, Cho S. The relationship of breakfast skipping and type of breakfast consumption with nutrient intake and weight status in children and adolescents: the National Health and Nutrition Examination Survey 1999-2006. J Am Diet Assoc. 2010 Jun;110(6):869-78. doi: 10.1016/j.jada.2010.03.023.
- Background: PubMed 12818304Nicklas TA, Yang SJ, Baranowski T, Zakeri I, Berenson G. Eating patterns and obesity in children. The Bogalusa Heart Study. Am J Prev Med. 2003 Jul;25(1):9-16. doi: 10.1016/s0749-3797(03)00098-9.
- Background: PubMed 20194979Piernas C, Popkin BM. Trends in snacking among U.S. children. Health Aff (Millwood). 2010 Mar-Apr;29(3):398-404. doi: 10.1377/hlthaff.2009.0666.
- Background: PubMed 21738451Duffey KJ, Popkin BM. Energy density, portion size, and eating occasions: contributions to increased energy intake in the United States, 1977-2006. PLoS Med. 2011 Jun;8(6):e1001050. doi: 10.1371/journal.pmed.1001050. Epub 2011 Jun 28.
- Background: PubMed 21536618Hammons AJ, Fiese BH. Is frequency of shared family meals related to the nutritional health of children and adolescents? Pediatrics. 2011 Jun;127(6):e1565-74. doi: 10.1542/peds.2010-1440. Epub 2011 May 2.
- Background: PubMed 21708800Council on Communications and Media; Strasburger VC. Children, adolescents, obesity, and the media. Pediatrics. 2011 Jul;128(1):201-8. doi: 10.1542/peds.2011-1066. Epub 2011 Jun 27.
- Background: PubMed 22271359Garcia G, Sunil TS, Hinojosa P. The fast food and obesity link: consumption patterns and severity of obesity. Obes Surg. 2012 May;22(5):810-8. doi: 10.1007/s11695-012-0601-8.
- BackgroundMoag-Stahlberg, A. 2010 ADAF Family nutrition and physical activity survey background data. 2010; Available from: www.Eatright.org.
- Background: PubMed 24004890Brown AW, Bohan Brown MM, Allison DB. Belief beyond the evidence: using the proposed effect of breakfast on obesity to show 2 practices that distort scientific evidence. Am J Clin Nutr. 2013 Nov;98(5):1298-308. doi: 10.3945/ajcn.113.064410. Epub 2013 Sep 4.
- Background: PubMed 25926512Leidy HJ, Clifton PM, Astrup A, Wycherley TP, Westerterp-Plantenga MS, Luscombe-Marsh ND, Woods SC, Mattes RD. The role of protein in weight loss and maintenance. Am J Clin Nutr. 2015 Jun;101(6):1320S-1329S. doi: 10.3945/ajcn.114.084038. Epub 2015 Apr 29.
- Background: PubMed 20125103Leidy HJ, Racki EM. The addition of a protein-rich breakfast and its effects on acute appetite control and food intake in 'breakfast-skipping' adolescents. Int J Obes (Lond). 2010 Jul;34(7):1125-33. doi: 10.1038/ijo.2010.3. Epub 2010 Feb 2.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather J Leidy, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HP-Beverage Breakfast, HP-Solid Breakfast and Breakfast Skipping in people with Appetite and General Nutritional Disorders, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hunger (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03031132, which also lists 48 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017.