High Protein Breakfast on Weight Management and Glycemic Control in 'Breakfast-skipping' Teens

April 30, 2019 updated by: Heather Leidy, Purdue University

Long-term Effects of Consuming a High Protein, Beef Breakfast on Weight Management and Glycemic Control in Overweight 'Breakfast-skipping' Young People

75 overweight, habitual 'breakfast-skipping' adolescents will complete the following long-term, randomized controlled trial. Participants will be randomly assigned to the following breakfast treatments: 350 kcal high protein breakfasts containing 30 g protein (primarily from lean beef), 35 g carbohydrates, and 10 g fat; 350 kcal normal protein breakfasts containing 10 g protein, 55 g carbohydrates, and 10 g fat; or will continue to skip breakfast. The following outcomes will be assessed during baseline and 4-month (post-intervention): body weight & body composition; waist circumference; daily food intake; 24-h free-living glycemic control; and pre and post-prandial satiety. In addition, body weight and free-living breakfast intake (quantity, quality, and type) will also be assessed at 2-month follow-up

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

The NP and HP groups will be provided with their respective breakfast meals to consume, at home, between 6:00-8:00 am each day over the 4-mo intervention. The energy content of the NP and HP breakfast meals will be standardized to 350 kcal. The energy content of the breakfast meals is ~18% of daily energy intake estimated from the energy expenditure equations specific for adolescents ages 13-16 y. The NP breakfasts will be 11% protein (10 g protein), 63% CHO, and 26% fat, whereas the HP breakfasts will be 34% protein (30 g protein), 40% CHO, and 26% fat. The types of protein incorporated within the NP and HP meals will include a combination of beef (40%), dairy (20%), eggs (20%), and plant-based (20%) proteins. The NP and HP meals will include the same types of breakfasts but will vary in protein and CHO content. An 8-d breakfast rotation will occur throughout the study.

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.
26

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
    • Indiana
      • West Lafayette, Indiana, United States, 47907
        • Purdue University

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 21 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males and females
  2. All ethnicities
  3. Age: 15-21y
  4. BMI/BMI Percentile: 20-34.0 kg/m2
  5. Never smoked or used other tobacco products
  6. Willing to consume the study breakfasts
  7. Generally healthy (as assessed by Medical History Questionnaire)

Exclusion Criteria:

  1. Clinically diagnosed with an eating disorder
  2. Metabolic, hormonal, and/or neural conditions/diseases that influence metabolism or appetite
  3. Currently or previously on a weight loss or other special diet (in the past 6 months)
  4. Gained/lost ≥4.5kg over the past 6 months
  5. Taking medication that would directly influence appetite (weight-loss drugs or antidepressant, steroid, or thyroid medication, unless dosage has been stable for at least 6 months)

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
No Intervention: Breakfast Skipping (BS)
The BS group will continue to skip breakfast.
Active Comparator: Normal Protein Breakfast (NP)
The NP groups will be provided with the respective breakfast meals to consume, at home, between 6:00-8:00 am each day over the 4-mo intervention. The energy content of the breakfast meals will be standardized to 350 kcal. The NP breakfasts will be 11% protein (10 g protein), 63% CHO, and 26% fat
Dietary supplement: Breakfast
If randomized to a breakfast consuming group, participants will be given breakfasts to consume between 6:00-8:00 am.
Active Comparator: High Protein Breakfast (HP)
The HP group will be provided with the respective breakfast meals to consume, at home, between 6:00-8:00 am each day over the 4-mo intervention. The energy content of the breakfast meals will be standardized to 350 kcal. The HP breakfasts will be 34% protein (30 g protein), 40% CHO, and 26% fat.
Dietary supplement: Breakfast
If randomized to a breakfast consuming group, participants will be given breakfasts to consume between 6:00-8:00 am.

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
Body Weight Change
Time Frame: Baseline and 4 months
Body weight will be determined with a standard scale.
Baseline and 4 months
Body Composition Change
Time Frame: Baseline and 4 months
Whole body total, fat, and fat free mass will be determined with DXA (GE) within the Bone and Body Composition Core of the Clinical Research Center. The DXA uses a linear X-ray fan beam with switched-pulse dual-energy and a multi-element detector array. The whole body scan takes <1.8 sec with radiation exposure of 0.01mGy. Waist circumference will be measured using a tape measure by one of the trained study staff members.
Baseline and 4 months
Energy Intake Change
Time Frame: Baseline and 4 months
To assess the participant's total energy content all subjects will complete 3 dietary recalls over a 7-day period. The 3 days of data will be averaged together. Trained staff will contact the participant on 3 separate days (over a 7-day period) and ask questions related to the quantity, type, brand, preparation, and timing of food consumed throughout the previous day. Average energy intake will be assessed using the multi-pass system and NDSR (Nutrition Data System for Research). Change in energy intake(assessed as total energy content in kcal) will be determined.
Baseline and 4 months
24-h Free-Living Glycemic Control Change
Time Frame: Baseline and 4 months
Free-living, glucose measures will be performed for 6 consecutive days using the Continuous Glucose Monitoring (CGM; Medtronic; Minneapolis, MN) used in our pilot study (1). The participants will report to our facility during the afternoon (on Day 1) for CGM insertion. A small area on the participant's abdomen will be cleaned and the tiny glucose sensor will be inserted just under the skin and held in place with tegaderm tape. The CGM measures glucose every 10sec and records an average glucose value every 5min for up to 144h. Calibration is performed by 4 finger sticks/d with a glucose analyzer.
Baseline and 4 months
Sleep Health Change
Time Frame: Baseline and 4 months
Sleep health will be measured during 7 consecutive days through accelerometry/actigraphy (Actiwatch, Respironics; Philips, Pittsburgh PA). This device will be worn on the wrist, and the participants will continuously wear it over a 7-day period for measures of sleep quality.
Baseline and 4 months
Daily Appetite Change
Time Frame: Baseline and 4 months
Questionnaires assessing the appetitive sensations (i.e., hunger, fullness, desire to eat, prospective food consumption), food cravings (sweet, savory-fat, meat), breakfast palatability (i.e., appearance, aroma, flavor, texture, overall liking), and perceived energy (sleepiness, energy, alertness) will be completed every waking hour for 3 days over a 7-day period. The questionnaires contain VAS incorporating a horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely." The questionnaires will be completed on an iPod Touch using an in-house designed application (ScaleKit).
Baseline and 4 months
Food Craving Inventory Change
Time Frame: Baseline and 4 months
Participants will fill out a Food Craving Inventory (FCI) questionnaire at baseline and 4-month (post-intervention). The FCI is a reliable and valid self-report measure of general and specific food cravings including cravings for high fat foods, carbohydrates/starches, sweets, and fast food (2). The FCI defines a craving as an intense desire to consume a particular food (or food type) that is difficult to resist. Further, this questionnaire prompts the participant to report how often (never, rarely, sometimes, often, always/almost every hour) he/she experienced a craving for the food throughout the day today.
Baseline and 4 months

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
Body Weight (2-months post-intervention termination) Change
Time Frame: 5 months and 6 months
Body weight will be determined with a standard scale.
5 months and 6 months
Breakfast Intake (2-months post-intervention termination) Change
Time Frame: Average of 3 days at 6 months
To assess the participant's energy content at breakfast, all subjects will complete 3 dietary recalls over a 7-day period and an average will of the 3 recalls will occur. Trained staff will contact the participant on 3 separate days (over a 7-day period) and ask questions related to the quantity, type, brand, preparation, and timing of food consumed throughout the previous breakfast meal. Breakfast energy content will be assessed using the multi-pass system and NDSR (Nutrition Data System for Research).
Average of 3 days at 6 months

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.
Purdue University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heather Leidy, PhD, Associate Professor; Clinical Research Center (CTSI) Director

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 (Actual)

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.
December 12, 2016

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 11, 2018

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.
May 11, 2018

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).
April 19, 2017

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.
April 27, 2017

First Posted (Actual)

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.
April 28, 2017

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.
May 2, 2019

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.
April 30, 2019

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.
April 1, 2019

More Information

Terms related to this study

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.
  • 1611018501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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