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

NCT01192100 | Completed Results DMC

• 1 other identifier: 1173258
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Keywords

Protein-rich breakfast; Breakfast Skipping; Adolescents; Obesity; Increased dietary protein; Breakfast; fMRI; Ghrelin; PYY

Outcome Measures

Primary Outcomes (3)

• Area Under the Curve (niAUC) of Perceived Hunger, Fullness, Desire to Eat, and Prospective Food Consumption

  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.

  5 weeks

• Area Under the Curve (AUC) of Plasma Total Ghrelin and Ln Peptide YY (PYY)

  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).

  5 weeks

• Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans

  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

  5 weeks

Secondary Outcomes (1)

• Daily Energy Intake

  5 weeks

Study Arms (3)

Breakfast Skipping

EXPERIMENTAL

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.

Behavioral: Breakfast Skipping

Normal Protein Breakfast Meals

EXPERIMENTAL

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.

Behavioral: Normal Protein Breakfast Meals

Protein-rich Breakfast Meals

EXPERIMENTAL

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.

Behavioral: Protein-rich Breakfast Meals

Interventions

Breakfast Skipping BEHAVIORAL

Participants will continue to skip breakfast each morning.

Also known as: Control

Breakfast Skipping

Normal Protein Breakfast Meals BEHAVIORAL

Participants will consume normal protein breakfast meals each morning.

Normal Protein Breakfast Meals

Protein-rich Breakfast Meals BEHAVIORAL

Participants will consume protein-rich breakfast meals each morning.

Protein-rich Breakfast Meals

Eligibility Criteria

• Age: 15 Years - 20 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• American Egg Board: collaborator
• National Cattlemen's Beef Association, a contractor to the Beef Checkoff: collaborator

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

Related Publications (1)

• 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.

  PMID: 23446906 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Intermittent Fasting

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Results Point of Contact

• Title: Dr. Heather Leidy
• Organization: Purdue University

hleidy@purdue.edu

765-496-0184

Study Officials

• Heather J Leidy, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 27, 2010
• First Posted: August 31, 2010
• Study Start: September 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 3, 2020
• Results First Posted: April 3, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)