ObesityNCT02795442
Daily Protein Intake Patterns on Energy Metabolism and the Motivation to Snack
A study testing Even protein and Skewed protein in people with Obesity, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Even protein and Skewed protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 14 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Even protein, Skewed protein
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Even proteinOther
5 day intake of even protein 3 day rotating menu.
Skewed proteinOther
5 day intake of skewed protein 3 day rotating menu.
| Study group | Role | What they receive |
|---|---|---|
| Even protein | Experimental | Menu to provide 90 g of protein per day in an even distribution of 30 g at each meal. Receives: Other: Even protein |
| Skewed protein | Experimental | 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. Receives: Other: Skewed protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat, carbohydrate, and protein utilization
The effect of consuming two patterns of daily protein intake on the use of fat, carbohydrate and protein for energy.
Measured: 4 hours after meal consumption
Relative reinforcing value (RRV) of energy-dense snack foods
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.
Measured: 2 hours after breakfast consumption
Secondary outcomes (3)
Peripheral neurotransmitter metabolites
The effect of consuming a high-protein or low-protein breakfast and an energy-dense snack food on dopamine and serotonin metabolite plasma concentrations.
Measured: 2 hours
Psychoactive Effect Questionnaire
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.
Measured: 2 hours
Satiety visual analog scales
The effect of consuming two patterns of daily protein intake on subjective measures of satiety.
Measured: 4 hours after meal consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion14 Feb 2024
- Study completion14 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Shanon Casperson, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795442
- Sponsor's protocol ID
- GFHNRC500
- Status last verified
- Nov 2025
- First submitted
- 6 Jun 2016
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Protein Intake Patterns on Energy Metabolism and the Motivation to Snack
- ClinicalTrials.gov ID
- NCT02795442
- Acronym / sponsor ID
- GFHNRC500
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- Jun 2016 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Even protein | Experimental | Other: Even proteinMenu to provide 90 g of protein per day in an even distribution of 30 g at each meal. |
| Skewed protein | Experimental | Other: Skewed proteinMenu 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Even protein5 day intake of even protein 3 day rotating menu. | Other | Even protein |
| Skewed protein5 day intake of skewed protein 3 day rotating menu. | Other | Skewed protein |
Primary outcome
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.
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.
3 secondary outcomes
Peripheral neurotransmitter metabolites
Time frame: 2 hours
Psychoactive Effect Questionnaire
Time frame: 2 hours
Satiety visual analog scales
Time frame: 4 hours after meal consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Grand Forks Human Nutrition Research Center Current Nutrition StudiesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanon Casperson, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Even protein and Skewed protein in people with Obesity, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat, carbohydrate, and protein utilization (time frame: 4 hours after meal consumption). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.