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Defining Beef and Meal Frequency as Key Components of a Healthy Eating Pattern for Muscle Health and Wellbeing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04232254
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : March 25, 2020
Sponsor:
Collaborator:
National Cattlemen's Beef Association
Information provided by (Responsible Party):
University of Illinois at Urbana-Champaign

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.


Condition or disease Intervention/treatment Phase
Meal Frequency Dietary Habits Muscle Protein Synthesis Behavioral: Animal-based Protein Foods Behavioral: Skewed Protein Distribution Behavioral: Plant-based Protein Foods Behavioral: Balanced Protein Distribution Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Defining Beef and Meal Frequency as Key Components of a Healthy Eating Pattern for Muscle Health and Wellbeing
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : August 1, 2022

Arm Intervention/treatment
Active Comparator: Animal Protein - Skewed Distribution
Animal-based protein foods with 3 meals per day consisting of 10-, 30-, and 60 g of dietary protein for breakfast, lunch, and dinner, respectively.
Behavioral: Animal-based Protein Foods
Participants will consume animal-based protein foods.

Behavioral: Skewed Protein Distribution
Participants will consume 3 meals per day consisting of 10-, 30-, 60 g 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 g of dietary protein for breakfast, lunch, and dinner, respectively.
Behavioral: Skewed Protein Distribution
Participants will consume 3 meals per day consisting of 10-, 30-, 60 g of dietary protein for breakfast, lunch, and dinner, respectively.

Behavioral: Plant-based Protein Foods
Participants will consume plant-based protein foods.

Experimental: Animal Protein - Balanced Distribution
Animal-based protein foods with 5 meals per day consisting of 20 g of dietary protein per meal.
Behavioral: Animal-based Protein Foods
Participants will consume animal-based protein foods.

Behavioral: Balanced Protein Distribution
Participants will consume 5 meals per day consisting of 20 g of dietary protein per meal.

Experimental: Plant Protein - Balanced Distribution
Plant-based protein foods with 5 meals per day consisting of 20 g of dietary protein per meal.
Behavioral: Plant-based Protein Foods
Participants will consume plant-based protein foods.

Behavioral: Balanced Protein Distribution
Participants will consume 5 meals per day consisting of 20 g of dietary protein per meal.




Primary Outcome Measures :
  1. 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

  2. Compare fractional synthesis rate of myofibrillar proteins to different dietary protein food [ Time Frame: 0-5 hours postprandial observation period following ingestion of a mixed meal from either plant- or animal-based sources ]
    Rate of building new protein in skeletal muscle contractile protein


Secondary Outcome Measures :
  1. Valence (Pleasantness or Unpleasantness) [ Time Frame: Immediately prior to workout, immediately post workout, and immediately post meal on experimental days 1-9 ]
    Measurement of feelings of un/pleasantness via survey responses to a measure of valence (Feeling Scale)

  2. Arousal (Alertness) [ Time Frame: Immediately prior to workout, immediately post workout, and immediately post meal on experimental days 1-9 ]
    Measurement of feelings of alertness to via survey responses to a measure of arousal (Felt Arousal Scale)

  3. Arousal (Alertness) [ Time Frame: Immediately prior to workout, immediately post workout, and immediately post meal on experimental days 1-9 ]
    Measurement of feelings of alertness to via survey responses to a measure of arousal (Activation-Deactivation Adjective Check List).



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04232254


Contacts
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Contact: Andrew T Askow, MS 608-630-0237 askow2@illinois.edu

Locations
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United States, Illinois
Freer Hall
Urbana, Illinois, United States, 61801
Contact: Nicholas A Burd, PhD    217-244-0970    naburd@illinois.edu   
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
National Cattlemen's Beef Association
Investigators
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Principal Investigator: Nicholas A Burd, PhD University of Illinois at Urbana-Champaign
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Responsible Party: University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT04232254    
Other Study ID Numbers: 20243
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No