Daily Protein Intake Patterns on Energy Metabolism and the Motivation to Snack

November 25, 2025 updated by: USDA Grand Forks Human Nutrition Research Center
The purpose of this study is to determine if when one eats protein can change how the body uses food for energy. Researchers will also test if eating a high protein breakfast can change one's craving for snack foods.

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 purpose of this study is to determine if consuming 30 g of high-quality protein at each meal can increase fat utilization and shift between-meal snack choices. While the benefits of high-protein diets are well known, little is known about the optimal amount of protein that should be eaten at each meal. Most Americans eat little protein at breakfast and lunch and most of their protein at the evening meal. Current guidelines for protein are based on body weight; however, recent evidence indicates that absolute amounts of protein at each meal are needed to maintain metabolically active fat-free mass. This suggests that a more even protein consumption pattern across daily meals may positively influence energy metabolism. In addition, recent evidence indicates that protein may reduce activity in the food reward areas of the brain. This suggests that protein may influence between-meal snacking by decreasing the relative reinforcing value (RRV) of highly rewarding snack foods. The RRV of a food is an empirical measure of its motivating value and energy-dense foods are highly reinforcing, especially for obese individuals. This study will be the first to investigate the role of the daily distribution of protein intake on energy metabolism and modifying snacking behavior.

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.
53

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Dakota
      • Grand Forks, North Dakota, United States, 58203
        • USDA Grand Forks Human Nutrition Research Center

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • BMI < 25 kg/m2
  • BMI ≥ 30 kg/m2 but < 34.5 kg/m2
  • able to understand and sign the informed consent
  • able to provide own transportation to the Center
  • free of any major illness/disease
  • usual protein intake within the acceptable macronutrient distribution range (10 to 30%)
  • constant habitual activity patterns within the last 3 months
  • females of childbearing age must be on birth control for a minimum of 3 months prior to study start and have regular menstrual cycles

Exclusion Criteria:

  • unable or unwilling to consume animal products
  • have had more than a 10% change in body weight within the past 2 months
  • are participating in a weight loss diet/exercise program
  • are consuming a specialized diet
  • currently or planning on becoming pregnant during the study timeline
  • lactating
  • have a metabolic illness/disease
  • have uncontrolled hypertension
  • have ever had cancer
  • have an infectious disease
  • suffer from alcohol or drug abuse
  • use tobacco and e-cigarette products on a regular basis
  • have the presence of acute illness
  • taking medications known to affect energy expenditure and appetite

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: Crossover Assignment
  • Masking: None (Open Label)

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: Even protein
Menu to provide 90 g of protein per day in an even distribution of 30 g at each meal.
Other: Even protein
5 day intake of even protein 3 day rotating menu.
Experimental: Skewed protein
Menu to provide 90 g of protein per day in a skewed distribution of 10 g at breakfast, 15 g at lunch and 65 g at dinner.
Other: Skewed protein
5 day intake of skewed protein 3 day rotating menu.

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
Fat, carbohydrate, and protein utilization
Time Frame: 4 hours after meal consumption
The effect of consuming two patterns of daily protein intake on the use of fat, carbohydrate and protein for energy.
4 hours after meal consumption
Relative reinforcing value (RRV) of energy-dense snack foods
Time Frame: 2 hours after breakfast consumption
The effect of consuming a high-protein or a low-protein breakfast on the RRV of energy-dense snack foods to a healthy snack food alternative.
2 hours after breakfast consumption

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
Peripheral neurotransmitter metabolites
Time Frame: 2 hours
The effect of consuming a high-protein or low-protein breakfast and an energy-dense snack food on dopamine and serotonin metabolite plasma concentrations.
2 hours
Psychoactive Effect Questionnaire
Time Frame: 2 hours
The effect of consuming a high-protein or low-protein breakfast and an energy-dense snack food on the number of positive responses on the Psychoactive Effects Questionnaire.
2 hours
Satiety visual analog scales
Time Frame: 4 hours after meal consumption
The effect of consuming two patterns of daily protein intake on subjective measures of satiety.
4 hours after meal consumption

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.
USDA Grand Forks Human Nutrition Research Center

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: Shanon Casperson, PhD, USDA Grand Forks Human Nutrition Research Center

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.

Helpful Links

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.
June 1, 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.
February 14, 2024

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.
February 14, 2024

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).
June 6, 2016

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.
June 6, 2016

First Posted (Estimated)

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.
June 10, 2016

Study Record Updates

Last Update Posted (Estimated)

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.
December 3, 2025

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.
November 25, 2025

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.
November 1, 2025

More Information

Terms related to this study

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.
  • GFHNRC500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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