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

27 de abril de 2021 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

23

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Texas
      • Galveston, Texas, Estados Unidos, 77555
        • Unversity of Texas Medical Branch

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

45 anos a 60 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: PRO-A
Beef protein
Outro: PRO-A
30 g of beef protein will be consumed at each meal
Experimental: PRO-B
Complementary proteins at each meal
Outro: PRO-B
30 g of complementary proteins will be consumed at each meal
Experimental: PRO-C
Complementary proteins over 24 hours
Outro: PRO-C
30 g of complementary proteins will be consumed over 24 hours
Sem intervenção: CON
Low protein (<5 g) meal

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Acute muscle protein synthesis: PRO-A
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Approximately 5 hours
Blood samples will be drawn to measure amino acid concentrations response to CON breakfast (µmol/L)
Approximately 5 hours

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Blood glucose response to diet: PRO-A
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

The University of Texas Medical Branch, Galveston

Investigadores

  • Investigador principal: Doug Paddon-Jones, PhD, University of Texas

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

26 de março de 2019

Conclusão Primária (Real)

21 de janeiro de 2021

Conclusão do estudo (Real)

21 de janeiro de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

22 de janeiro de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de janeiro de 2019

Primeira postagem (Real)

25 de janeiro de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de abril de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de abril de 2021

Última verificação

1 de dezembro de 2020

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 18-0147

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Não

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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