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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03816579
Acronym
MAPP
Enrollment
23
Registered
2019-01-25
Start date
2019-03-26
Completion date
2021-01-21
Last updated
2021-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet, Protein, Skeletal Muscle

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.

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.

Interventions

OTHERPRO-A

30 g of beef protein will be consumed at each meal

OTHERPRO-B

30 g of complementary proteins will be consumed at each meal

OTHERPRO-C

30 g of complementary proteins will be consumed over 24 hours

Sponsors

The University of Texas Medical Branch, Galveston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
45 Years to 60 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Acute muscle protein synthesis: PRO-A3 hours after consuming mealMuscle protein synthesis response to PRO-A breakfast meal (%/h)
Acute muscle protein synthesis: PRO-B3 hours after consuming mealMuscle protein synthesis response to PRO-B breakfast meal (%/h)
Acute muscle protein synthesis: PRO-C3 hours after consuming mealMuscle protein synthesis response to PRO-C breakfast meal (%/h)
Acute muscle protein synthesis: CON3 hours after consuming mealMuscle protein synthesis response to CON breakfast meal (%/hour)
24-hour muscle protein synthesis: PRO-AApproximately 24 hoursMuscle protein synthesis response to PRO-A diet over 24 hours (%/hour)
24-hour muscle protein synthesis: PRO-BApproximately 24 hoursMuscle protein synthesis response to PRO-B diet over 24 hours (%/hour)
24-hour muscle protein synthesis: PRO-CApproximately 24 hoursMuscle protein synthesis response to PRO-C diet over 24 hours (%/hour)
Blood amino acid response to diet: PRO-AApproximately 5 hoursBlood samples will be drawn to measure amino acid concentrations response to PRO-A breakfast (µmol/L)
Blood amino acid response to diet: PRO-BApproximately 5 hoursBlood samples will be drawn to measure amino acid concentrations response to PRO-B breakfast (µmol/L)
Blood amino acid response to diet: PRO-CApproximately 5 hoursBlood samples will be drawn to measure amino acid concentrations response to PRO-B C breakfast (µmol/L)
Blood amino acid response to diet: CONApproximately 5 hoursBlood samples will be drawn to measure amino acid concentrations response to CON breakfast (µmol/L)

Secondary

MeasureTime frameDescription
3 day dietary record: CONApproximately 36 hoursDiet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to CON study visit
Palatability Questionnaire:PRO-AApproximately 8 hoursQuestionnaires 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.
Blood glucose response to diet: PRO-AApproximately 24 hoursBlood samples will be drawn to measure blood glucose response to PRO-A diet (mg/dl)
Palatability Questionnaire:PRO-CApproximately 8 hoursQuestionnaires 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.
Palatability Questionnaire:CONApproximately 5 hoursQuestionnaires 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.
Palatability Questionnaire:PRO-BApproximately 8 hoursQuestionnaires 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.
Blood glucose response to diet: PRO-BApproximately 24 hoursBlood samples will be drawn to measure blood glucose response to PRO-B diet (mg/dl)
Blood glucose response to diet: PRO-CApproximately 24 hoursBlood samples will be drawn to measure blood glucose response to PRO-C diet (mg/dl)
Blood glucose response to diet: CONApproximately 5 hoursBlood samples will be drawn to measure blood glucose response to CON breakfast meal (mg/dl)
Appetite and Hedonic Questionnaire: PRO-AApproximately 8 hoursQuestionnaires 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.
Appetite and Hedonic Questionnaire: PRO-BApproximately 8 hoursQuestionnaires 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.
Appetite and Hedonic Questionnaire: PRO-CApproximately 8 hoursQuestionnaires 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.
Appetite and Hedonic Questionnaire: CONApproximately 5 hoursQuestionnaires 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.
3 day dietary record: PRO-AApproximately 36 hoursDiet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-A study visit
3 day dietary record: PRO-BApproximately 36 hoursDiet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-B study visit
3 day dietary record: PRO-CApproximately 36 hoursDiet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-C study visit

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026