Grand Forks, North Dakota 58203

  • Obesity

Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

GFHNRC500


NCT ID:

NCT02795442


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

20 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

USDA Grand Forks Human Nutrition Research Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Shanon Casperson, PhD
Principal Investigator
USDA Grand Forks Human Nutrition Research Center
Primary Contact:Shanon Casperson, PhD
701-795-8497
shanon.casperson@usda.gov

Study Dates

Start Date:June 2016
Completion Date:June 2022
Completion Type:Anticipated
Primary Completion Date:March 2022
Primary Completion Type:Anticipated
Verification Date:April 2021
Last Changed Date:April 1, 2021
First Received Date:June 6, 2016

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Satiety visual analog scales
Time Frame:4 hours after meal consumption
Safety Issues:False
Description:The effect of consuming two patterns of daily protein intake on subjective measures of satiety.
Outcome Type:Secondary Outcome
Measure:Psychoactive Effect Questionnaire
Time Frame:2 hours
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Peripheral neurotransmitter metabolites
Time Frame:2 hours
Safety Issues:False
Description:The effect of consuming a high-protein or low-protein breakfast and an energy-dense snack food on dopamine and serotonin metabolite plasma concentrations.
Outcome Type:Primary Outcome
Measure:Relative reinforcing value (RRV) of energy-dense snack foods
Time Frame:2 hours after breakfast consumption
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Fat, carbohydrate, and protein utilization
Time Frame:4 hours after meal consumption
Safety Issues:False
Description:The effect of consuming two patterns of daily protein intake on the use of fat, carbohydrate and protein for energy.

Study Interventions

Intervention Type:Other
Name:Skewed protein
Description:5 day intake of skewed protein 3 day rotating menu.
Arm Name:Skewed protein
Intervention Type:Other
Name:Even protein
Description:5 day intake of even protein 3 day rotating menu.
Arm Name:Even protein

Study Arms

Study Arm Type:Experimental
Arm Name:Skewed protein
Description: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.
Study Arm Type:Experimental
Arm Name:Even protein
Description:Menu to provide 90 g of protein per day in an even distribution of 30 g at each meal.

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:USDA Grand Forks Human Nutrition Research Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 24, 2021

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