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

March 23, 2020 updated by: Heather Leidy, University of Missouri-Columbia
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65211
        • University of Missouri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Breakfast Skipping
Participants will continue to skip breakfast each morning.
Other Names:
  • Control
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.
Behavioral: Normal Protein Breakfast Meals
Participants will consume normal protein breakfast meals each morning.
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.
Behavioral: Protein-rich Breakfast Meals
Participants will consume protein-rich breakfast meals each morning.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Area Under the Curve (niAUC) of Perceived Hunger, Fullness, Desire to Eat, and Prospective Food Consumption
Time Frame: 5 weeks
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)
Time Frame: 5 weeks
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
Time Frame: 5 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Daily Energy Intake
Time Frame: 5 weeks
Energy intake during breakfast, lunch, dinner, and evening snacks of each testing day will be measured.
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Missouri-Columbia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cattlemen's Beef Association
American Egg Board

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2010

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1173258

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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