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A Meal-based Comparison of Protein Quality, Complementary Proteins and Muscle Anabolism (MAPP)

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ClinicalTrials.gov Identifier: NCT03816579
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief Summary:
To highlight the importance of protein quality rather than the total protein content of a meal, the investigators will demonstrate that unlike high quality proteins, a single meal containing 30 g of an incomplete protein source does not stimulate skeletal muscle protein synthesis. Secondly, the investigators will directly challenge a prevalent, but untested, assertion that has the potential to negatively impact health. The goal is to demonstrate that complementary plant-proteins (i.e., two or more incomplete protein sources) must be consumed at the same meal to stimulate protein synthesis.

Condition or disease Intervention/treatment Phase
Protein Diet Skeletal Muscle Other: PRO-A Other: PRO-B Other: PRO-C Not Applicable

Detailed Description:

The investigators will test the following hypotheses in middle-aged men and women (45-60) years old using a randomized, cross over design. All study objectives will be met concurrently:

  1. Meals containing 30 g of high quality, predominantly beef-protein (PRO-A) will stimulate acute (i.e., single meal response) and 24 h skeletal muscle protein synthesis [confirmatory hypothesis]
  2. Meals containing 30 g of complementary plant-based proteins (PRO-B: complete essential amino acid profile at each meal) will stimulate acute and 24 h skeletal muscle protein synthesis, but to a lesser extent than beef-protein.
  3. A single meal containing 30 g of an incomplete plant-based protein source (PRO-C: lacking one essential amino acid) will fail to acutely stimulate skeletal muscle protein synthesis
  4. Meals containing 30 g of plant-based protein that are incomplete at each separate meal, but complementary over a 24 h period, will fail to stimulate 24 h skeletal muscle protein synthesis.
  5. Beef-and plant-based meals will have a similar effect on satiety and 24 h blood glucose [descriptive]

If these hypotheses are correct, the investigators will demonstrate that meals containing a moderate amount of high quality protein, such as beef, are an efficient and effective way to augment a largely plant based diet and stimulate skeletal muscle protein synthesis - a prerequisite for outcomes related to physical function, performance, successful aging and metabolic health.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: A Meal-based Comparison of Protein Quality, Complementary Proteins and Muscle Anabolism
Actual Study Start Date : March 26, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Experimental: PRO-A
Beef protein
Other: PRO-A
30 g of beef protein will be consumed at each meal

Experimental: PRO-B
Complementary proteins at each meal
Other: PRO-B
30 g of complementary proteins will be consumed at each meal

Experimental: PRO-C
Complementary proteins over 24 hours
Other: PRO-C
30 g of complementary proteins will be consumed over 24 hours

No Intervention: CON
Low protein (<5 g) meal



Primary Outcome Measures :
  1. Acute muscle protein synthesis: PRO-A [ Time Frame: 3 hours after consuming meal ]
    Muscle protein synthesis response to PRO-A breakfast meal (%/h)

  2. Acute muscle protein synthesis: PRO-B [ Time Frame: 3 hours after consuming meal ]
    Muscle protein synthesis response to PRO-B breakfast meal (%/h)

  3. Acute muscle protein synthesis: PRO-C [ Time Frame: 3 hours after consuming meal ]
    Muscle protein synthesis response to PRO-C breakfast meal (%/h)

  4. Acute muscle protein synthesis: CON [ Time Frame: 3 hours after consuming meal ]
    Muscle protein synthesis response to CON breakfast meal (%/hour)

  5. 24-hour muscle protein synthesis: PRO-A [ Time Frame: Approximately 24 hours ]
    Muscle protein synthesis response to PRO-A diet over 24 hours (%/hour)

  6. 24-hour muscle protein synthesis: PRO-B [ Time Frame: Approximately 24 hours ]
    Muscle protein synthesis response to PRO-B diet over 24 hours (%/hour)

  7. 24-hour muscle protein synthesis: PRO-C [ Time Frame: Approximately 24 hours ]
    Muscle protein synthesis response to PRO-C diet over 24 hours (%/hour)

  8. Blood amino acid response to diet: PRO-A [ Time Frame: Approximately 5 hours ]
    Blood samples will be drawn to measure amino acid concentrations response to PRO-A breakfast (µmol/L)

  9. Blood amino acid response to diet: PRO-B [ Time Frame: Approximately 5 hours ]
    Blood samples will be drawn to measure amino acid concentrations response to PRO-B breakfast (µmol/L)

  10. Blood amino acid response to diet: PRO-C [ Time Frame: Approximately 5 hours ]
    Blood samples will be drawn to measure amino acid concentrations response to PRO-B C breakfast (µmol/L)

  11. Blood amino acid response to diet: CON [ Time Frame: Approximately 5 hours ]
    Blood samples will be drawn to measure amino acid concentrations response to CON breakfast (µmol/L)


Secondary Outcome Measures :
  1. Blood glucose response to diet: PRO-A [ Time Frame: Approximately 24 hours ]
    Blood samples will be drawn to measure blood glucose response to PRO-A diet (mg/dl)

  2. Blood glucose response to diet: PRO-B [ Time Frame: Approximately 24 hours ]
    Blood samples will be drawn to measure blood glucose response to PRO-B diet (mg/dl)

  3. Blood glucose response to diet: PRO-C [ Time Frame: Approximately 24 hours ]
    Blood samples will be drawn to measure blood glucose response to PRO-C diet (mg/dl)

  4. Blood glucose response to diet: CON [ Time Frame: Approximately 5 hours ]
    Blood samples will be drawn to measure blood glucose response to CON breakfast meal (mg/dl)

  5. Appetite and Hedonic Questionnaire: PRO-A [ Time Frame: Approximately 8 hours ]
    Questionnaires will be given to assess hunger, fullness, desire to eat, thirst, desire to eat something sweet, desire to eat something salty, desire to eat something savory, sleepiness, physical energy, mental energy, and nausea in response to PRO-A diet. All outcomes are scored individually on a 10 pt visual analog scale using "not at all" being 0 and "extremely" being a 10.

  6. Appetite and Hedonic Questionnaire: PRO-B [ Time Frame: Approximately 8 hours ]
    Questionnaires will be given to assess hunger, fullness, desire to eat, thirst, desire to eat something sweet, desire to eat something salty, desire to eat something savory, sleepiness, physical energy, mental energy, and nausea in response to PRO-B diet. All outcomes are scored individually on a 10 pt visual analog scale using "not at all" being 0 and "extremely" being a 10.

  7. Appetite and Hedonic Questionnaire: PRO-C [ Time Frame: Approximately 8 hours ]
    Questionnaires will be given to assess hunger, fullness, desire to eat, thirst, desire to eat something sweet, desire to eat something salty, desire to eat something savory, sleepiness, physical energy, mental energy, and nausea in response to PRO-C diet. All outcomes are scored individually on a 10 pt visual analog scale using "not at all" being 0 and "extremely" being a 10.

  8. Appetite and Hedonic Questionnaire: CON [ Time Frame: Approximately 5 hours ]
    Questionnaires will be given to assess hunger, fullness, desire to eat, thirst, desire to eat something sweet, desire to eat something salty, desire to eat something savory, sleepiness, physical energy, mental energy, and nausea in response to CON diet. All outcomes are scored individually on a 10 pt visual analog scale using "not at all" being 0 and "extremely" being a 10.

  9. 3 day dietary record: PRO-A [ Time Frame: Approximately 36 hours ]
    Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-A study visit

  10. 3 day dietary record: PRO-B [ Time Frame: Approximately 36 hours ]
    Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-B study visit

  11. 3 day dietary record: PRO-C [ Time Frame: Approximately 36 hours ]
    Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-C study visit

  12. 3 day dietary record: CON [ Time Frame: Approximately 36 hours ]
    Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to CON study visit

  13. Palatability Questionnaire:PRO-A [ Time Frame: Approximately 8 hours ]
    Questionnaires will be given to assess palatability of the PRO-A diet. Outcomes include the participants ranking of the food appearance, aroma intensity, aroma, flavor intensity, flavor, texture and overall appeal of the food. A 10 pt visual analog scale will be used to assess the subject's response with 0 being "extremely dislike", 5 being "neither like nor dislike" and 10 being "extremely like".

  14. Palatability Questionnaire:PRO-B [ Time Frame: Approximately 8 hours ]
    Questionnaires will be given to assess palatability of the PRO-B diet. Outcomes include the participants ranking of the food appearance, aroma intensity, aroma, flavor intensity, flavor, texture and overall appeal of the food. A 10 pt visual analog scale will be used to assess the subject's response with 0 being "extremely dislike", 5 being "neither like nor dislike" and 10 being "extremely like".

  15. Palatability Questionnaire:PRO-C [ Time Frame: Approximately 8 hours ]
    Questionnaires will be given to assess palatability of the PRO-C diet. Outcomes include the participants ranking of the food appearance, aroma intensity, aroma, flavor intensity, flavor, texture and overall appeal of the food. A 10 pt visual analog scale will be used to assess the subject's response with 0 being "extremely dislike", 5 being "neither like nor dislike" and 10 being "extremely like".

  16. Palatability Questionnaire:CON [ Time Frame: Approximately 5 hours ]
    Questionnaires will be given to assess palatability of the CON diet. Outcomes include the participants ranking of the food appearance, aroma intensity, aroma, flavor intensity, flavor, texture and overall appeal of the food. A 10 pt visual analog scale will be used to assess the subject's response with 0 being "extremely dislike", 5 being "neither like nor dislike" and 10 being "extremely like".



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. All races and ethnic backgrounds
  2. Men and women, age 45-60 years
  3. Generally healthy (see exclusion criteria)
  4. Able and willing to provide informed consent
  5. Ability to speak and read English (* the study procedures, e.g., muscle biopsy, duration of each acute study, e.g. overnight stay; and multiple dietary questionnaires require sound written and spoken English)

Exclusion Criteria:

  1. Sarcopenia (defined by: European Working Group on Sarcopenia in Older People, EWGSOP (44))
  2. Clinically significant heart disease (e.g. New York Heart Classification greater than grade II; ischemia)
  3. Peripheral vascular disease
  4. Pulmonary disease
  5. History of systemic or pulmonary embolus
  6. Uncontrolled blood pressure (systolic BP>170, diastolic BP>95 mmHg)
  7. Impaired renal function (creatinine >1.5 mg/dl)
  8. Anemia (hematocrit <33)
  9. Untreated thyroid disease (abnormal TSH)
  10. A recent history (<12 months) of GI bleed
  11. Diabetes mellitus or other untreated endocrine or metabolic disease
  12. Electrolyte abnormalities
  13. Any history of stroke, hypo- or hyper-coagulation disorders
  14. Recent (3 years) treated cancer other than basal cell carcinoma
  15. Systemic steroids, anabolic steroids, growth hormone or immunosuppressant use within 12 months
  16. Recent (6 months) adherence to a weight-loss or weight-gain diet
  17. Weight change of 5% or more in previous 6 months
  18. Body mass index >30 or excess body fat that compromises muscle biopsy collection
  19. Body mass index <20 or recent history (<12 month) of disordered eating
  20. Dietary preferences or practices that preclude the consumption of the study meals
  21. Acute infectious disease or chronic infection
  22. Alcohol or drug abuse
  23. Any other condition or event considered exclusionary by study physician
  24. Pregnancy

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): NCT03816579


Contacts
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Contact: Emily Lantz, PhD 281-886-3018 ejlantz@utmb.edu
Contact: Doug Paddon-Jones, PhD (409) 772-3073 djpaddon@utmb.edu

Locations
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United States, Texas
Unversity of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Principal Investigator: Douglas Paddon-Jones, Ph.D.         
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
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Principal Investigator: Doug Paddon-Jones, PhD University of Texas
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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03816579    
Other Study ID Numbers: 18-0147
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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