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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02795442
Enrollment
53
Registered
2016-06-10
Start date
2016-06-30
Completion date
2024-02-14
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

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.

Interventions

5 day intake of even protein 3 day rotating menu.

5 day intake of skewed protein 3 day rotating menu.

Sponsors

USDA Grand Forks Human Nutrition Research Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Fat, carbohydrate, and protein utilization4 hours after meal consumptionThe 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 foods2 hours after breakfast consumptionThe 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.

Secondary

MeasureTime frameDescription
Peripheral neurotransmitter metabolites2 hoursThe effect of consuming a high-protein or low-protein breakfast and an energy-dense snack food on dopamine and serotonin metabolite plasma concentrations.
Psychoactive Effect Questionnaire2 hoursThe 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.
Satiety visual analog scales4 hours after meal consumptionThe effect of consuming two patterns of daily protein intake on subjective measures of satiety.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026