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

27 kwietnia 2021 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

23

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Texas
      • Galveston, Texas, Stany Zjednoczone, 77555
        • Unversity of Texas Medical Branch

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

45 lat do 60 lat (Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: PRO-A
Beef protein
Inny: PRO-A
30 g of beef protein will be consumed at each meal
Eksperymentalny: PRO-B
Complementary proteins at each meal
Inny: PRO-B
30 g of complementary proteins will be consumed at each meal
Eksperymentalny: PRO-C
Complementary proteins over 24 hours
Inny: PRO-C
30 g of complementary proteins will be consumed over 24 hours
Brak interwencji: CON
Low protein (<5 g) meal

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Acute muscle protein synthesis: PRO-A
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Approximately 5 hours
Blood samples will be drawn to measure amino acid concentrations response to CON breakfast (µmol/L)
Approximately 5 hours

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Blood glucose response to diet: PRO-A
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

The University of Texas Medical Branch, Galveston

Śledczy

  • Główny śledczy: Doug Paddon-Jones, PhD, University of Texas

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

26 marca 2019

Zakończenie podstawowe (Rzeczywisty)

21 stycznia 2021

Ukończenie studiów (Rzeczywisty)

21 stycznia 2021

Daty rejestracji na studia

Pierwszy przesłany

22 stycznia 2019

Pierwszy przesłany, który spełnia kryteria kontroli jakości

24 stycznia 2019

Pierwszy wysłany (Rzeczywisty)

25 stycznia 2019

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

29 kwietnia 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 kwietnia 2021

Ostatnia weryfikacja

1 grudnia 2020

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 18-0147

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

Nie

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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