Clinical trial NCT01192100: The Beneficial Effects of a Protein-rich Breakfast on Appetite Control & Cognition in Overweight and Obese Adolescents
Official title: The Beneficial Effects of a Protein-rich Breakfast on Appetite Control & Cognition in Overweight and Obese Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Protein-rich breakfast
Breakfast Skipping
Adolescents
Obesity
Increased dietary protein
Breakfast
fMRI
Ghrelin
PYY
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: American Egg Board
name: National Cattlemen's Beef Association
First posted: 2010-08-31
Enrollment: 22
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Curve (niAUC) of Perceived Hunger, Fullness, Desire to Eat, and Prospective Food Consumption
timeFrame: 5 weeks
measure: Area Under the Curve (AUC) of Plasma Total Ghrelin and Ln Peptide YY (PYY)
timeFrame: 5 weeks
measure: Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans
timeFrame: 5 weeks
Secondary outcomes:
measure: Daily Energy Intake
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Heather J Leidy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.