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

27. april 2021 opdateret af: The University of Texas Medical Branch, Galveston
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

23

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Texas
      • Galveston, Texas, Forenede Stater, 77555
        • Unversity of Texas Medical Branch

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

45 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: PRO-A
Beef protein
Andet: PRO-A
30 g of beef protein will be consumed at each meal
Eksperimentel: PRO-B
Complementary proteins at each meal
Andet: PRO-B
30 g of complementary proteins will be consumed at each meal
Eksperimentel: PRO-C
Complementary proteins over 24 hours
Andet: PRO-C
30 g of complementary proteins will be consumed over 24 hours
Ingen indgriben: CON
Low protein (<5 g) meal

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acute muscle protein synthesis: PRO-A
Tidsramme: 3 hours after consuming meal
Muscle protein synthesis response to PRO-A breakfast meal (%/h)
3 hours after consuming meal
Acute muscle protein synthesis: PRO-B
Tidsramme: 3 hours after consuming meal
Muscle protein synthesis response to PRO-B breakfast meal (%/h)
3 hours after consuming meal
Acute muscle protein synthesis: PRO-C
Tidsramme: 3 hours after consuming meal
Muscle protein synthesis response to PRO-C breakfast meal (%/h)
3 hours after consuming meal
Acute muscle protein synthesis: CON
Tidsramme: 3 hours after consuming meal
Muscle protein synthesis response to CON breakfast meal (%/hour)
3 hours after consuming meal
24-hour muscle protein synthesis: PRO-A
Tidsramme: Approximately 24 hours
Muscle protein synthesis response to PRO-A diet over 24 hours (%/hour)
Approximately 24 hours
24-hour muscle protein synthesis: PRO-B
Tidsramme: Approximately 24 hours
Muscle protein synthesis response to PRO-B diet over 24 hours (%/hour)
Approximately 24 hours
24-hour muscle protein synthesis: PRO-C
Tidsramme: Approximately 24 hours
Muscle protein synthesis response to PRO-C diet over 24 hours (%/hour)
Approximately 24 hours
Blood amino acid response to diet: PRO-A
Tidsramme: Approximately 5 hours
Blood samples will be drawn to measure amino acid concentrations response to PRO-A breakfast (µmol/L)
Approximately 5 hours
Blood amino acid response to diet: PRO-B
Tidsramme: Approximately 5 hours
Blood samples will be drawn to measure amino acid concentrations response to PRO-B breakfast (µmol/L)
Approximately 5 hours
Blood amino acid response to diet: PRO-C
Tidsramme: Approximately 5 hours
Blood samples will be drawn to measure amino acid concentrations response to PRO-B C breakfast (µmol/L)
Approximately 5 hours
Blood amino acid response to diet: CON
Tidsramme: Approximately 5 hours
Blood samples will be drawn to measure amino acid concentrations response to CON breakfast (µmol/L)
Approximately 5 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood glucose response to diet: PRO-A
Tidsramme: Approximately 24 hours
Blood samples will be drawn to measure blood glucose response to PRO-A diet (mg/dl)
Approximately 24 hours
Blood glucose response to diet: PRO-B
Tidsramme: Approximately 24 hours
Blood samples will be drawn to measure blood glucose response to PRO-B diet (mg/dl)
Approximately 24 hours
Blood glucose response to diet: PRO-C
Tidsramme: Approximately 24 hours
Blood samples will be drawn to measure blood glucose response to PRO-C diet (mg/dl)
Approximately 24 hours
Blood glucose response to diet: CON
Tidsramme: Approximately 5 hours
Blood samples will be drawn to measure blood glucose response to CON breakfast meal (mg/dl)
Approximately 5 hours
Appetite and Hedonic Questionnaire: PRO-A
Tidsramme: 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.
Approximately 8 hours
Appetite and Hedonic Questionnaire: PRO-B
Tidsramme: 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.
Approximately 8 hours
Appetite and Hedonic Questionnaire: PRO-C
Tidsramme: 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.
Approximately 8 hours
Appetite and Hedonic Questionnaire: CON
Tidsramme: 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.
Approximately 5 hours
3 day dietary record: PRO-A
Tidsramme: 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
Approximately 36 hours
3 day dietary record: PRO-B
Tidsramme: 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
Approximately 36 hours
3 day dietary record: PRO-C
Tidsramme: 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
Approximately 36 hours
3 day dietary record: CON
Tidsramme: Approximately 36 hours
Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to CON study visit
Approximately 36 hours
Palatability Questionnaire:PRO-A
Tidsramme: 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".
Approximately 8 hours
Palatability Questionnaire:PRO-B
Tidsramme: 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".
Approximately 8 hours
Palatability Questionnaire:PRO-C
Tidsramme: 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".
Approximately 8 hours
Palatability Questionnaire:CON
Tidsramme: 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".
Approximately 5 hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The University of Texas Medical Branch, Galveston

Efterforskere

  • Ledende efterforsker: Doug Paddon-Jones, PhD, University of Texas

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. marts 2019

Primær færdiggørelse (Faktiske)

21. januar 2021

Studieafslutning (Faktiske)

21. januar 2021

Datoer for studieregistrering

Først indsendt

22. januar 2019

Først indsendt, der opfyldte QC-kriterier

24. januar 2019

Først opslået (Faktiske)

25. januar 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. april 2021

Sidst verificeret

1. december 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 18-0147

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