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

NCT ID: NCT01192100

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-08-31

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.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Breakfast Skipping

Intervention Type: BEHAVIORAL

Participants will continue to skip breakfast each morning.

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.

Group Type: EXPERIMENTAL

Normal Protein Breakfast Meals

Intervention Type: BEHAVIORAL

Participants will consume normal protein breakfast meals each morning.

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.

Group Type: EXPERIMENTAL

Protein-rich Breakfast Meals

Intervention Type: BEHAVIORAL

Participants will consume protein-rich breakfast meals each morning.

Interventions

Breakfast Skipping

Participants will continue to skip breakfast each morning.

Intervention Type: BEHAVIORAL

Normal Protein Breakfast Meals

Participants will consume normal protein breakfast meals each morning.

Intervention Type: BEHAVIORAL

Protein-rich Breakfast Meals

Participants will consume protein-rich breakfast meals each morning.

Intervention Type: BEHAVIORAL

Other Intervention Names

Control

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

American Egg Board

OTHER

Sponsor Role: collaborator

National Cattlemen's Beef Association

INDUSTRY

Sponsor Role: collaborator

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Heather Leidy

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heather J Leidy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri

Columbia, Missouri, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23446906 (View on PubMed)

Other Identifiers

1173258

Identifier Type: -

Identifier Source: org_study_id