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Completed

NCT Number: NCT02795442

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

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Even protein

Other

5 day intake of even protein 3 day rotating menu.

Skewed protein

Other

5 day intake of skewed protein 3 day rotating menu.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

USDA Grand Forks Human Nutrition Research Center

Fed

Registry information

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Jun 10, 2016
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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