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Completed

NCT Number: NCT03816579

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

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.

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Key information

Conditions

Protein Diet Skeletal Muscle

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unversity of Texas Medical Branch

Galveston, Texas, 77555, United States

About this study

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:

  • 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]
  • 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.
  • 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
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All races and ethnic backgrounds
  • Men and women, age 45-60 years
  • Generally healthy (see exclusion criteria)
  • Able and willing to provide informed consent
  • 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

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

Treatment and study plan

PRO-A

Other

30 g of beef protein will be consumed at each meal

PRO-B

Other

30 g of complementary proteins will be consumed at each meal

PRO-C

Other

30 g of complementary proteins will be consumed over 24 hours

Primary outcomes

  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 outcomes

  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".

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Acronym: MAPP

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 25, 2019
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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