NCT04232254

Brief Summary

Adopting a healthy eating pattern is important for meeting dietary recommendations and weight management. Although less clear, it seems reasonable to assume that the eating patterns we typically follow can also affect our psychological wellbeing. As such, healthy eating patterns are often adapted to suit one's personal preference. For example, many people choose to follow a vegetarian-style eating pattern whereby meat, poultry, and seafood are excluded from the diet. However, current research suggests that vegetarian eating patterns may result in decreased synthesis of new muscle proteins when compared to the typical meat-based US-style diet. This ultimately leads to reduced muscle quality and mass which increases the risk of dependence and mobility limitations later in life. Another important factor to consider when adapting a healthy eating pattern is the frequency and distribution of meals throughout the day. In the US, protein intake is typically skewed throughout the day such that people consume more protein at dinner when compared to breakfast. This skewed distribution combined with a low meal frequency (3 meals per day) can also sacrifice the rate of muscle protein synthesis. As such, it is important to investigate the interaction between food choices, meal frequency, and protein distribution to promote muscle health and prevent development of disease and disability. In addition, it is also important to understand how these eating patterns affect enjoyment and pleasure following meals. This work will help to determine healthy eating patterns that promote muscle health and psychological wellbeing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

January 9, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2024

Completed
Last Updated

August 17, 2025

Status Verified

October 1, 2024

Enrollment Period

2.8 years

First QC Date

January 9, 2020

Last Update Submit

August 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Compare fractional synthesis rate of myofibrillar proteins to different dietary protein food sources and meal frequencies

    Rate of building new protein in skeletal muscle contractile protein

    Day 1 - Day 9

Secondary Outcomes (3)

  • Valence (Pleasantness or Unpleasantness)

    Immediately prior to workout, immediately post workout, and immediately post meal on habituation days 2, 4, and 6 and intervention days 3, 5, and 7

  • Arousal (Alertness)

    Immediately prior to workout, immediately post workout, and immediately post meal on habituation days 2, 4, and 6 and intervention days 3, 5, and 7

  • Arousal (Alertness)

    Immediately prior to workout, immediately post workout, and immediately post meal on habituation days 2, 4, and 6 and intervention days 3, 5, and 7

Study Arms (4)

Animal Protein - Skewed Distribution

ACTIVE COMPARATOR

Animal-based protein foods with 3 meals per day consisting of 10-, 30-, and 60% of dietary protein for breakfast, lunch, and dinner, respectively.

Behavioral: Animal-based Protein FoodsBehavioral: Skewed Protein Distribution

Plant Protein - Skewed Distribution

EXPERIMENTAL

Plant-based protein foods with 3 meals per day consisting of 10-, 30-, and 60% of dietary protein for breakfast, lunch, and dinner, respectively.

Behavioral: Skewed Protein DistributionBehavioral: Plant-based Protein Foods

Animal Protein - Balanced Distribution

EXPERIMENTAL

Animal-based protein foods with 5 meals per day consisting of 20% of dietary protein per meal.

Behavioral: Animal-based Protein FoodsBehavioral: Balanced Protein Distribution

Plant Protein - Balanced Distribution

EXPERIMENTAL

Plant-based protein foods with 5 meals per day consisting of 20% of dietary protein per meal.

Behavioral: Plant-based Protein FoodsBehavioral: Balanced Protein Distribution

Interventions

Participants will consume animal-based protein foods.

Animal Protein - Balanced DistributionAnimal Protein - Skewed Distribution

Participants will consume 3 meals per day consisting of 10-, 30-, 60% of dietary protein for breakfast, lunch, and dinner, respectively.

Animal Protein - Skewed DistributionPlant Protein - Skewed Distribution

Participants will consume plant-based protein foods.

Plant Protein - Balanced DistributionPlant Protein - Skewed Distribution

Participants will consume 5 meals per day consisting of 20% of dietary protein per meal.

Animal Protein - Balanced DistributionPlant Protein - Balanced Distribution

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20-40
  • Pre-menopausal
  • Recreationally active
  • Weight stable for prior 6 months
  • Consumption of meat-based diet for \>6 months

You may not qualify if:

  • Age outside of range (20 - 40)
  • Pregnancy
  • Irregular menstrual cycles
  • Participation in previous research using 2H2O or \[13C6\]phenylalanine
  • Participation in other ongoing research that interferes with this study (e.g., conflicting diet, activity interventions, etc.)
  • Any hospitalization or surgery for a metabolic, cardiovascular, or neuromusculoskeletal complication within the past year
  • Allergy or hypersensitivity to local anesthetics, latex, or adhesives (bandages, medical tape, etc.)
  • Excess scarring after injury
  • History of excess bleeding after cut
  • Chronic or frequent dizziness/fainting, and arm or leg weakness/numbness
  • Arthritis
  • Tumors
  • Mental Illness
  • Hepatorenal, cardiovascular musculoskeletal, autoimmune, or neurological disease or disorder
  • Predisposition to hypertrophic scarring or keloid formation
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Freer Hall

Urbana, Illinois, 61801, United States

Location

Related Publications (1)

  • Askow AT, Barnes TM, Zupancic Z, Deutz MT, Paulussen KJM, McKenna CF, Salvador AF, Ulanov AV, Paluska SA, Willard JW, Petruzzello SJ, Burd NA. Impact of Vegan Diets on Resistance Exercise-Mediated Myofibrillar Protein Synthesis in Healthy Young Males and Females: A Randomized Controlled Trial. Med Sci Sports Exerc. 2025 Sep 1;57(9):1923-1934. doi: 10.1249/MSS.0000000000003725. Epub 2025 Apr 4.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Nicholas A Burd, PhD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 18, 2020

Study Start

June 1, 2021

Primary Completion

March 14, 2024

Study Completion

March 14, 2024

Last Updated

August 17, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

No IPD will be shared with other researchers

Locations