Daily Protein Intake Patterns on Energy Metabolism and the Motivation to Snack
1 other identifier
interventional
53
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Jun 2016
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 6, 2016
CompletedFirst Posted
Study publicly available on registry
June 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2024
CompletedDecember 3, 2025
November 1, 2025
7.7 years
June 6, 2016
November 25, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
2 hours after breakfast consumption
Secondary Outcomes (3)
Peripheral neurotransmitter metabolites
2 hours
Psychoactive Effect Questionnaire
2 hours
Satiety visual analog scales
4 hours after meal consumption
Study Arms (2)
Even protein
EXPERIMENTALMenu to provide 90 g of protein per day in an even distribution of 30 g at each meal.
Skewed protein
EXPERIMENTALMenu 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shanon Casperson, PhD
USDA Grand Forks Human Nutrition Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2016
First Posted
June 10, 2016
Study Start
June 1, 2016
Primary Completion
February 14, 2024
Study Completion
February 14, 2024
Last Updated
December 3, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share