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

27. April 2021 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

23

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Texas
      • Galveston, Texas, Vereinigte Staaten, 77555
        • Unversity of Texas Medical Branch

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

45 Jahre bis 60 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: PRO-A
Beef protein
Sonstiges: PRO-A
30 g of beef protein will be consumed at each meal
Experimental: PRO-B
Complementary proteins at each meal
Sonstiges: PRO-B
30 g of complementary proteins will be consumed at each meal
Experimental: PRO-C
Complementary proteins over 24 hours
Sonstiges: PRO-C
30 g of complementary proteins will be consumed over 24 hours
Kein Eingriff: CON
Low protein (<5 g) meal

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Acute muscle protein synthesis: PRO-A
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Approximately 5 hours
Blood samples will be drawn to measure amino acid concentrations response to CON breakfast (µmol/L)
Approximately 5 hours

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Blood glucose response to diet: PRO-A
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

The University of Texas Medical Branch, Galveston

Ermittler

  • Hauptermittler: Doug Paddon-Jones, PhD, University of Texas

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

26. März 2019

Primärer Abschluss (Tatsächlich)

21. Januar 2021

Studienabschluss (Tatsächlich)

21. Januar 2021

Studienanmeldedaten

Zuerst eingereicht

22. Januar 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. Januar 2019

Zuerst gepostet (Tatsächlich)

25. Januar 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. April 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. April 2021

Zuletzt verifiziert

1. Dezember 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 18-0147

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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