NCT02795442

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2024

Completed
Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

7.7 years

First QC Date

June 6, 2016

Last Update Submit

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

EXPERIMENTAL

Menu to provide 90 g of protein per day in an even distribution of 30 g at each meal.

Other: Even protein

Skewed protein

EXPERIMENTAL

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.

Other: Skewed protein

Interventions

5 day intake of even protein 3 day rotating menu.

Even protein

5 day intake of skewed protein 3 day rotating menu.

Skewed protein

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shanon Casperson, PhD

    USDA Grand Forks Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

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

Locations