- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04232254
Defining Beef and Meal Frequency as Key Components of a Healthy Eating Pattern for Muscle Health and Wellbeing
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
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Urbana, Illinois, United States, 61801
- Freer Hall
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 20-40
- Pre-menopausal
- Recreationally active
- Weight stable for prior 6 months
- Consumption of meat-based diet for >6 months
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Animal Protein - Skewed Distribution
Animal-based protein foods with 3 meals per day consisting of 10-, 30-, and 60% of dietary protein for breakfast, lunch, and dinner, respectively.
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Participants will consume animal-based protein foods.
Participants will consume 3 meals per day consisting of 10-, 30-, 60% of dietary protein for breakfast, lunch, and dinner, respectively.
|
|
Experimental: Plant Protein - Skewed Distribution
Plant-based protein foods with 3 meals per day consisting of 10-, 30-, and 60% of dietary protein for breakfast, lunch, and dinner, respectively.
|
Participants will consume 3 meals per day consisting of 10-, 30-, 60% of dietary protein for breakfast, lunch, and dinner, respectively.
Participants will consume plant-based protein foods.
|
|
Experimental: Animal Protein - Balanced Distribution
Animal-based protein foods with 5 meals per day consisting of 20% of dietary protein per meal.
|
Participants will consume animal-based protein foods.
Participants will consume 5 meals per day consisting of 20% of dietary protein per meal.
|
|
Experimental: Plant Protein - Balanced Distribution
Plant-based protein foods with 5 meals per day consisting of 20% of dietary protein per meal.
|
Participants will consume plant-based protein foods.
Participants will consume 5 meals per day consisting of 20% of dietary protein per meal.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compare fractional synthesis rate of myofibrillar proteins to different dietary protein food sources and meal frequencies
Time Frame: Day 1 - Day 9
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Rate of building new protein in skeletal muscle contractile protein
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Day 1 - Day 9
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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Measurement of feelings of un/pleasantness via survey responses to a measure of valence (Feeling Scale)
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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
|
Measurement of feelings of alertness to via survey responses to a measure of arousal (Felt Arousal Scale)
|
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
|
Measurement of feelings of alertness to via survey responses to a measure of arousal (Activation-Deactivation Adjective Check List).
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nicholas A Burd, PhD, University of Illinois at Urbana-Champaign
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20243
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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