- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02795442
Daily Protein Intake Patterns on Energy Metabolism and the Motivation to Snack
April 19, 2024 updated by: Shanon Casperson, 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
Active, not recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
26
Phase
- 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
-
-
North Dakota
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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
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 |
Intervention / Treatment |
---|---|
Experimental: Even protein
Menu to provide 90 g of protein per day in an even distribution of 30 g at each meal.
|
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.
|
5 day intake of skewed protein 3 day rotating menu.
|
What is the study measuring?
Primary Outcome Measures
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
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.
Investigators
- 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.
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)
June 1, 2016
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
June 6, 2016
First Submitted That Met QC Criteria
June 6, 2016
First Posted (Estimated)
June 10, 2016
Study Record Updates
Last Update Posted (Actual)
April 23, 2024
Last Update Submitted That Met QC Criteria
April 19, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID 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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