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

This study has been completed.
Sponsor:
Collaborators:
American Egg Board
National Cattlemen's Beef Association
Information provided by (Responsible Party):
Heather Leidy, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01192100
First received: August 27, 2010
Last updated: January 26, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Overweight
Obesity
Other: Dietary Interventions: Normal protein/protein-rich breakfast meals

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Beneficial Effects of a Protein-rich Breakfast on Appetite Control & Cognition in Overweight and Obese Adolescents

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Perceived Appetite and Satiety [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Daily Energy Intake [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    Energy intake during breakfast, lunch, dinner, and evening snacks of each testing day will be measured.


Enrollment: 25
Study Start Date: September 2010
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Dietary Interventions: Normal protein/protein-rich breakfast meals
The participants will complete, in randomized order, the following breakfast patterns at home (before school) for 6 days: 1) Breakfast Skipping; 2) Consumption of Normal Protein Breakfast Meals; and 3) Consumption of Protein-Rich Breakfast Meals. On the 7th day of each pattern (which will occur on Saturdays), the participants will report to the University of Missouri's Brain Imaging Center in the morning to complete the respective 12-h testing day.
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.
Other: Dietary Interventions: Normal protein/protein-rich breakfast meals
The participants will complete, in randomized order, the following breakfast patterns at home (before school) for 6 days: 1) Breakfast Skipping; 2) Consumption of Normal Protein Breakfast Meals; and 3) Consumption of Protein-Rich Breakfast Meals. On the 7th day of each pattern (which will occur on Saturdays), the participants will report to the University of Missouri's Brain Imaging Center in the morning to complete the respective 12-h testing day.
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.
Other: Dietary Interventions: Normal protein/protein-rich breakfast meals
The participants will complete, in randomized order, the following breakfast patterns at home (before school) for 6 days: 1) Breakfast Skipping; 2) Consumption of Normal Protein Breakfast Meals; and 3) Consumption of Protein-Rich Breakfast Meals. On the 7th day of each pattern (which will occur on Saturdays), the participants will report to the University of Missouri's Brain Imaging Center in the morning to complete the respective 12-h testing day.

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. 25 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

Ages Eligible for Study:   15 Years to 20 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192100

Locations
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65211
Sponsors and Collaborators
University of Missouri-Columbia
American Egg Board
National Cattlemen's Beef Association
  More Information

No publications provided by University of Missouri-Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Heather Leidy, Assistant Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01192100     History of Changes
Other Study ID Numbers: 1173258
Study First Received: August 27, 2010
Last Updated: January 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
Protein-rich breakfast
Breakfast Skipping
Adolescents
Obesity
Increased dietary protein
Breakfast
fMRI
Ghrelin
PYY

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014