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

University of Missouri (MU) logo

University of Missouri (MU)

Status

Completed

Conditions

Overweight
Obesity

Treatments

Behavioral: Protein-rich Breakfast Meals
Behavioral: Breakfast Skipping
Behavioral: Normal Protein Breakfast Meals

Study type

Interventional

Funder types

Other

Identifiers

NCT01192100
1173258

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

Female

Ages

15 to 20 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

22 participants in 3 patient groups

Breakfast Skipping
Experimental group
Description:
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.
Treatment:
Behavioral: Breakfast Skipping
Normal Protein Breakfast Meals
Experimental group
Description:
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.
Treatment:
Behavioral: Normal Protein Breakfast Meals
Protein-rich Breakfast Meals
Experimental group
Description:
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.
Treatment:
Behavioral: Protein-rich Breakfast Meals

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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