Meal FrequencyNCT04232254
Defining Beef and Meal Frequency as Key Components of a Healthy Eating Pattern for Muscle Health and Wellbeing
A study testing Animal-based Protein Foods, Skewed Protein Distribution and Plant-based Protein Foods in people with Meal Frequency and Dietary Habits, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Meal Frequency, Dietary Habits, Muscle Protein Synthesis
- What is being tested?
- Animal-based Protein Foods, Skewed Protein Distribution and Plant-based Protein Foods
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 14 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-40
- Pre-menopausal
- Recreationally active
- Weight stable for prior 6 months
- Consumption of meat-based diet for >6 months
Who cannot join
- 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
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- 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
- Physical activity limitations
- Consumption of ergogenic-levels of dietary supplements that may affect muscle mass (e.g., creatine, HMB), insulin-like substances, or anabolic/catabolic pro-hormones (e.g., DHEA) within 6 weeks prior to participation
- Consumption of thyroid, androgenic, or other medications known to affect endocrine function
- Consumption of medications known to affect protein metabolism (e.g., prescription-strength corticosteroids, nonsteroidal anti-inflammatories, or acne medication)
- Unwillingness to comply with study procedures
- Weight unstable (variation >5% of bodyweight in last 6-12 months)
- Pregnancy
- Allergy to dairy product or lactose intolerance
- Current or previous tobacco use with last 6 months
- Obesity (body mass index; BMI > 30 kg m-2)
- Score of less than 14 or greater than 24 on Godin-Shephard Leisure-Time Physical Activity Questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Meal Frequency, Dietary Habits, Muscle Protein Synthesis
- Being tested
- Animal-based Protein Foods, Skewed Protein Distribution, Plant-based Protein Foods, Balanced Protein Distribution
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal-based Protein FoodsBehavioural
Participants will consume animal-based protein foods.
Skewed Protein DistributionBehavioural
Participants will consume 3 meals per day consisting of 10-, 30-, 60% of dietary protein for breakfast, lunch, and dinner, respectively.
Plant-based Protein FoodsBehavioural
Participants will consume plant-based protein foods.
Balanced Protein DistributionBehavioural
Participants will consume 5 meals per day consisting of 20% of dietary protein per meal.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Animal-based Protein Foods; Behavioral: 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. Receives: Behavioral: Skewed Protein Distribution; Behavioral: 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. Receives: Behavioral: Animal-based Protein Foods; Behavioral: 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. Receives: Behavioral: Plant-based Protein Foods; Behavioral: Balanced Protein Distribution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 - Day 9
Secondary outcomes (3)
Valence (Pleasantness or Unpleasantness)
Measurement of feelings of un/pleasantness via survey responses to a measure of valence (Feeling Scale)
Measured: 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)
Measurement of feelings of alertness to via survey responses to a measure of arousal (Felt Arousal Scale)
Measured: 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)
Measurement of feelings of alertness to via survey responses to a measure of arousal (Activation-Deactivation Adjective Check List).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Jun 2021
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meal FrequencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Responsible party
- Sponsor
- Investigators
- Nicholas A Burd, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232254
- Sponsor's protocol ID
- 20243
- Status last verified
- Oct 2024
- First submitted
- 9 Jan 2020
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers
Publications
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.
PubMed 40197715
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Beef and Meal Frequency as Key Components of a Healthy Eating Pattern for Muscle Health and Wellbeing
- ClinicalTrials.gov ID
- NCT04232254
- Acronym / sponsor ID
- 20243
- Conditions
- Meal Frequency, Dietary Habits, Muscle Protein Synthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Animal Protein - Skewed Distribution | Active comparator | Behavioral: Animal-based Protein Foods, Behavioral: Skewed Protein DistributionAnimal-based protein foods with 3 meals per day consisting of 10-, 30-, and 60% of dietary protein for breakfast, lunch, and dinner, respectively. |
| Plant Protein - Skewed Distribution | Experimental | Behavioral: Skewed Protein Distribution, Behavioral: Plant-based Protein FoodsPlant-based protein foods with 3 meals per day consisting of 10-, 30-, and 60% of dietary protein for breakfast, lunch, and dinner, respectively. |
| Animal Protein - Balanced Distribution | Experimental | Behavioral: Animal-based Protein Foods, Behavioral: Balanced Protein DistributionAnimal-based protein foods with 5 meals per day consisting of 20% of dietary protein per meal. |
| Plant Protein - Balanced Distribution | Experimental | Behavioral: Plant-based Protein Foods, Behavioral: Balanced Protein DistributionPlant-based protein foods with 5 meals per day consisting of 20% of dietary protein per meal. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 20-40
- Pre-menopausal
- Recreationally active
- Weight stable for prior 6 months
- Consumption of meat-based diet for >6 months
Key exclusion criteria (26 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal-based Protein FoodsParticipants will consume animal-based protein foods. | Behavioural | Animal Protein - Balanced Distribution, Animal Protein - Skewed Distribution |
| Skewed Protein DistributionParticipants will consume 3 meals per day consisting of 10-, 30-, 60% of dietary protein for breakfast, lunch, and dinner, respectively. | Behavioural | Animal Protein - Skewed Distribution, Plant Protein - Skewed Distribution |
| Plant-based Protein FoodsParticipants will consume plant-based protein foods. | Behavioural | Plant Protein - Balanced Distribution, Plant Protein - Skewed Distribution |
| Balanced Protein DistributionParticipants will consume 5 meals per day consisting of 20% of dietary protein per meal. | Behavioural | Animal Protein - Balanced Distribution, Plant Protein - Balanced Distribution |
Primary outcome
Compare fractional synthesis rate of myofibrillar proteins to different dietary protein food sources and meal frequencies
Time frame: Day 1 - Day 9
Rate of building new protein in skeletal muscle contractile protein
3 secondary outcomes
Valence (Pleasantness or Unpleasantness)
Time frame: 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)
Time frame: 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)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Derived from this study: PubMed 40197715Askow 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.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas A Burd, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal-based Protein Foods, Skewed Protein Distribution and Plant-based Protein Foods in people with Meal Frequency and Dietary Habits, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare fractional synthesis rate of myofibrillar proteins to different dietary protein food sources and meal frequencies (time frame: Day 1 - Day 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04232254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.