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The Beneficial Effects of a Protein-rich Breakfast on Appetite Control & Cognition in Overweight and Obese Adolescents

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ClinicalTrials.gov Identifier: NCT01192100
Recruitment Status : Completed
First Posted : August 31, 2010
Results First Posted : April 3, 2020
Last Update Posted : April 3, 2020
Sponsor:
Collaborators:
American Egg Board
National Cattlemen's Beef Association
Information provided by (Responsible Party):
Heather Leidy, University of Missouri-Columbia

Tracking Information
First Submitted Date  ICMJE August 27, 2010
First Posted Date  ICMJE August 31, 2010
Results First Submitted Date  ICMJE April 19, 2017
Results First Posted Date  ICMJE April 3, 2020
Last Update Posted Date April 3, 2020
Study Start Date  ICMJE September 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
  • Area Under the Curve (niAUC) of Perceived Hunger, Fullness, Desire to Eat, and Prospective Food Consumption [ Time Frame: 5 weeks ]
    Computerized questionnaires, assessing perceived sensations of hunger and fullness were completed throughout the testing days beginning at baseline and about every 30 minutes for a total of 20 questionnaires (- 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min). The questions are worded as "how strong is your feeling of" with anchors of "not at all" to "extremely." Each reported score can be a minimum of 0 and a maximum of 100 mm. niAUC was calculated by computing the summation of the average change from baseline score (mm) for each time point and the subsequent time point, multiplied by the difference in time (min) between the two measures. For reported feelings of hunger, a higher score can be interpreted as "feeling more hungry" throughout the day. This can be applied to the three other perceived sensations.
  • Area Under the Curve (AUC) of Plasma Total Ghrelin and Ln Peptide YY (PYY) [ Time Frame: 5 weeks ]
    The samples were collected in test tubes containing ethylenediaminetetraacetic acid. Protease inhibitors (pefabloc SC and dipeptidyl peptidase) were added to some of the tubes to reduce protein degradation. The plasma was separated and stored in microcentrifuge tubes at -80°C for future analysis. Plasma total ghrelin and peptide YY (PYY) were measured for all time points using the Milliplex multi-analyte profiling magnetic bead-based multi-analyte, metabolic panel, 2-plex assay and Magpix Luminex technologies. AUC was calculated by computing the summation of the average change from baseline score (pg/ml) for each time point and the subsequent time point multiplied by the difference in time (min) between the two time instances for a total of 20 blood samples (- 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min).
  • Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans [ Time Frame: 5 weeks ]
    Participants viewed 3 categories of pictures including food, nonfood (animals), and blurred baseline images. The pictures from each category were presented in blocks of images. Animal pictures were used to control for visual richness and general interest (i.e., appealing but not appetizing). To determine the effects of breakfast/no breakfast on neural activity associated with food motivation, repeated measures ANOVAs were performed on the brain activation maps within the Brain Voyager software with use of stimulus [food (i.e., appetizing and appealing) vs. nonfood (i.e., animal, nonappetizing but appealing]. To identify significant activations in a priori regions, a cluster level statistical threshold was applied to correct for multiple comparisons. By using this approach, significance was set at P = 0.01, with a cluster-level false-positive rate of a = 0.05
Original Primary Outcome Measures  ICMJE
 (submitted: August 30, 2010)
  • Perceived Appetite and Satiety [ Time Frame: 5 weeks ]
    Questionnaires, assessing appetite sensations (i.e., hunger, fullness, prospective food consumption, motivation to eat), hedonic ratings (pleasure), and palatability will be completed throughout each of the testing days (which are separated by 2 weeks). 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."
  • Appetite and Satiety Hormones (i.e., Ghrelin, PYY) [ Time Frame: 5 weeks ]
    25 total blood samples will be drawn throughout each of the testing days (which are separated by 2 weeks). Specifically, there will be 5 ml/sample; 125 ml (4.2 oz)/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 15 minutes. The plasma will then be separated and stored in microcentrifuge tubes at -80°C for future analysis. Plasma total ghrelin and total PYY will be measure.
  • Functional Magnetic Resonance Imaging (fMRI) Brain Activation Responses [ Time Frame: 5 weeks ]
    Brain activation responses will be assessed prior to dinner 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2010)
Daily Energy Intake [ Time Frame: 5 weeks ]
Energy intake during breakfast, lunch, dinner, and evening snacks of each testing day will be measured.
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 Beneficial Effects of a Protein-rich Breakfast on Appetite Control & Cognition in Overweight and Obese Adolescents
Official Title  ICMJE The Beneficial Effects of a Protein-rich Breakfast on Appetite Control & Cognition in Overweight and Obese Adolescents
Brief Summary The purpose of this study is to assess whether the daily addition of a protein-rich breakfast leads to beneficial changes in appetite control, food intake regulation,and cognitive function in overweight & obese 'breakfast skipping' young women.
Detailed Description Breakfast skipping, which is a common, yet unhealthy dietary habit among young women, has been strongly associated with over-eating (especially in the evening), weight gain, and obesity. Breakfast skipping has also been shown to reduce cognitive function in this population. However, it is unclear as to whether the addition of breakfast, with specific emphasis on increased dietary protein, leads to improvements in these outcomes. This study will provide mechanistic evidence supporting the addition of a protein-rich breakfast to improve and/or re-establish appetite control, energy intake regulation, and cognitive function in overweight/obese 'breakfast skipping' young women. 22 overweight and obese 'breakfast skipping' adolescent girls will participate in the following randomized within-subject crossover-design breakfast study. The participants will randomly complete the follow breakfast patterns at home for 6 days: 1) Breakfast Skipping; 2) Consumption of Normal Protein breakfast meals(i.e., 350 kcal; 15% of the meal as protein, 65% CHO, & 20% fat); and 3) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% of the meal as protein, 40% CHO, & 20% fat). On the 7th day of each pattern, the participants will report to the MU-Brain Imaging Center in the morning to complete the respective 10-h testing day. The participants will begin the testing day by either skipping breakfast or consuming their respective breakfast meal. Blood samples and assessments of perceived appetite, pleasure/reward, and cognitive function will be collected/completed at specific times throughout the day. A standardized lunch will also be provided. Prior to dinner, a brain scan will be completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. Following the fMRI, the participants will be provided with an ad libitum dinner buffet to consume of the facility. They will also be given evening snacks to consume ad libitum, at home throughout the remainder of the day. There is a 7-day washout period between each breakfast pattern. Primary outcomes include morning, mid-day, afternoon, and evening appetite, satiety, pleasure/reward, hormonal responses (plasma glucose, insulin, ghrelin, and PYY concentrations), 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Overweight
  • Obesity
Intervention  ICMJE
  • Behavioral: Breakfast Skipping
    Participants will continue to skip breakfast each morning.
    Other Name: Control
  • Behavioral: Normal Protein Breakfast Meals
    Participants will consume normal protein breakfast meals each morning.
  • Behavioral: Protein-rich Breakfast Meals
    Participants will consume protein-rich breakfast meals each morning.
Study Arms  ICMJE
  • Experimental: Breakfast Skipping
    Breakfast skipping serves as the baseline/control arm since the participants habitually skip breakfast (i.e., skip breakfast at least 5 times/week). Thus, during the week prior to and including the testing day, the participants will continue to skip breakfast each morning.
    Intervention: Behavioral: Breakfast Skipping
  • Experimental: Normal Protein Breakfast Meals
    For 7 days, the participants will consume normal protein breakfast meals each morning. These meals will consist of cereal-based foods and will be 350 kcal, which is approximately 18% of daily energy intake for overweight and obese adolescents ages 9-18 y. The macronutrient composition of these meals will contain 15% protein (13 g of dietary protein), 65% CHO, and 20% fat.
    Intervention: Behavioral: Normal Protein Breakfast Meals
  • Experimental: Protein-rich Breakfast Meals
    For 7 days, the participants will consume protein-rich breakfast meals each morning. These meals will consist of home-cooked foods and will be 350 kcal, which is approximately 18% of daily energy intake for overweight and obese adolescents ages 9-18 y. The macronutrient composition of these meals will contain 40% protein (35 g of protein), 40% CHO, and 20% fat.
    Intervention: Behavioral: Protein-rich Breakfast Meals
Publications * Leidy 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.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2020)
22
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2010)
25
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

The participants must meet the following inclusion criteria:

  • Female
  • Age range 15-20 y
  • Overweight to obese (85th -99th percentile for BMI for age; BMI: 25-39.9 kg/m2
  • No metabolic, psychological, or neurological diseases/conditions
  • Not currently/previously on a weight loss/other special diet
  • Frequently eats lunch ( ≥ 5 eating occasions/wk)
  • Consistently skips breakfast every week day (i.e., 5 week days/week)
  • Right-handed (necessary for the fMRI analyses)

Exclusion Criteria:

The participants will be excluded from participation in the study if they meet the following exclusion criteria:

  • Male
  • Age >20 y and <15 y
  • Under Weight (<5th percentile for BMI for age; BMI: <18 kg/m2)
  • Normal Weight (6th-84th percentile for BMI for age; BMI: 18-24.0 kg/m2)
  • Morbidly Obese (BMI: >40 kg/m2)
  • Clinically diagnosed with diabetes (Type I or Type II), having an eating disorder, or having any other metabolic, psychological, or neurological diseases/conditions that would influence the study outcomes.
  • Not currently/previously on a weight loss or other special diet (in the past 6 months)
  • Skip lunch ( ≥ 2 eating occasions/wk)
  • Consume breakfast (≥ 2 eating occasions/wk)
  • Left-handed
  • Claustrophobic (≥ 2 past bouts of claustrophobia when exposure to small spaces)
  • Do not meet the fMRI criteria established by the MU-BIC (regarding metal implants, etc.)
  • Pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years to 20 Years   (Child, 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 NCT01192100
Other Study ID Numbers  ICMJE 1173258
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, University of Missouri-Columbia
Study Sponsor  ICMJE University of Missouri-Columbia
Collaborators  ICMJE
  • American Egg Board
  • National Cattlemen's Beef Association
Investigators  ICMJE
Principal Investigator: Heather J Leidy, PhD University of Missouri-Columbia
PRS Account University of Missouri-Columbia
Verification Date March 2020

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