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Dietary Protein Quality for Skeletal Muscle Anabolism in Older Adults

5 de outubro de 2022 atualizado por: University of Birmingham

The Importance of Dietary Protein Quality for Skeletal Muscle Anabolism in Older Adults

Dietary proteins potently augment muscle protein synthesis. Because of poorer anabolic sensitivity with ageing, studies and guidelines recommend higher dietary protein intake for older adults. Although higher doses would benefit skeletal muscle remodelling, large protein consumption is not feasible for many older adults. To circumvent, high-protein quality which possesses a high amino acid profile and digestibility appears to have an emergent role for supporting anabolism. Since currently the best line of defence against age related muscle loss is resistance exercise training and regular protein consumption, emphasising high-quality protein ingestion, such as whey protein, within meals may be feasible and efficacious in supporting musculoskeletal remodelling in older adults, without requirement for large protein doses.

The investigators propose that at low doses, high quality protein will have additive benefit to muscle protein synthesis compared to low-quality protein. Further, combining high-quality protein diets with resistance exercise training will have more profound benefits for muscle protein synthesis and muscle remodelling more so than low-quality protein diets.

Visão geral do estudo

Descrição detalhada

Participants will be randomly assigned to a 10-day dietary intervention consuming primarily animal proteins (high-quality condition) or primarily plant proteins (low-quality condition). In both conditions, participants will undertake supervised single-leg resistance exercise training every other day, amassing five days resistance exercise sessions during the study. The groups will aim to be matched and counterbalanced for gender. Equally for unilateral exercise randomisation for leg dominance will aim to be counterbalanced within both groups.

Preliminary assessments:

5 days preceding the start of the dietary intervention, participants will report to the University of Birmingham, Sport, Exercise and Rehabilitation Science for the following:

  1. Health questionnaire
  2. Written informed consent
  3. Anthropometrics (Height and Weight)
  4. Body fat (bioelectrical impedance)
  5. Start measuring habitual activity (provided with an activity monitor and pedometer)
  6. Start measuring habitual diet (provided with diet diary)

2 days preceding the start of the dietary intervention, participants will report to the University of Birmingham, Sport, Exercise and Rehabilitation Science for the following:

  1. Saliva sample (participant gives own saliva sample in a tube)
  2. 10ml of blood taken for baseline measures (venepuncture by trained phlebotomist)
  3. Loading dose of D2O (stable isotope of water ingested in 8 small 50ml doses taken 1 hour apart throughout the day)
  4. Find 1 repetition maximum (1RM) during unilateral knee extension.

Dietary intervention each day throughout 10-day intervention participants will provide a saliva sample and then consume a top up dose of D2O, continue wearing an activity tracker and keep a diet diary to record eating times of provided meals.

Meals will be individualised to body weight for each individual to achieve a moderate protein intake of which will then consist of primarily higher quality or lower quality proteins.

Day 0 (first day of diet), participants will report to the University of Birmingham, Sport, Exercise and Rehabilitation Science at 0800h after fasting >10 hours the night prior for the following:

  1. Resting metabolic rate (Laying down for 30 minutes to assess gaseous exchange while wearing a mask)
  2. Muscle architecture (using non-invasive ultrasonography)
  3. Whole-body composition assessment (DXA scan)
  4. Bilateral muscle biopsies (small amount of muscle will be taken from the muscle in the thigh (vastus lateralis) by a trained person from the left and right leg, under local anaesthetic)
  5. Maximal muscle strength (isometric dynamometry) and neural activation (interpolated twitch) during maximal muscle contraction on both legs in series.
  6. Serial blood samples will be taken with a single cannulisation and 8 10ml blood draws taken throughout the visit (before and after consuming a breakfast which is either higher or lower in protein quality, according to the randomised condition).
  7. Perceived appetite will be assessed during the visit, before and after breakfast, using visual analogue scales
  8. Urine collection tub will be provided to collect urine over the next 24-hours.

After consuming specified breakfast on this visit, participants will continue to eat meals given to them according to their random allocation of either higher or lower quality protein diets.

Day 1, 3, 5, 7, 9

Participants will report to the University of Birmingham, Sport, Exercise and Rehabilitation Science to undergo single-leg resistance exercise on a knee extension machine. Eight sets will be completed on the machine at each visit at 75% of 1RM (determined during preliminary visits and will be supervised).

On day 9, the participant will be given a urine collection tub to collect urine over the next 24-hours.

Day 10 (Diet finishing during this visit), participants will report to the University of Birmingham, Sport, Exercise and Rehabilitation Science at 0800h after fasting >10 hours the night prior for the following assessments:

  1. Resting metabolic rate (Laying down for 30 minutes to assess gaseous exchange while wearing a mask)
  2. Whole-body composition assessment (DXA scan)
  3. Muscle Architecture (using non-invasive ultrasonography)
  4. Maximal muscle strength (Isometric Dynamometry) and neural activation during maximal muscle contraction (Interpolated twitch)
  5. Bilateral muscle biopsies (small amount of muscle will be taken from the muscle in the thigh (vastus lateralis) from the left and right leg under local anaesthetic
  6. Serial blood samples will be taken with a single cannulisation and 8 10ml blood draws taken throughout the visit (before and after consuming the final meal of the diet which is the breakfast which is either higher or lower in protein quality, according to the randomised condition)
  7. Perceived appetite will be assessed during the visit, before and after breakfast, using visual analogue scales.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

40

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.

Contato de estudo

Estude backup de contato

Locais de estudo

    • West Midlands
      • Edgbaston, West Midlands, Reino Unido, B15 2TT
        • Recrutamento
        • University of Birmingham, School of Sport, Exercise and Rehabilitation Sciences
        • Contato:
        • Contato:
          • Marie Korzepa, MSc

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

50 anos a 70 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Males and Females aged between 50-70 years
  • Accustomed to normal physical activity levels (averaging at least 7000 steps a day)
  • Healthy body mass (i.e., BMI 18-25 kg/m2)
  • General good health indicated by health questionnaire
  • Free from COVID-19 (SARS-CoV-2) symptoms.

Exclusion Criteria:

  • Habitually high consumers of protein (>1.6g/kg/day) assessed by habitual diet diary
  • Food allergies
  • Lidocaine allergy
  • Smoker
  • Bleeding Disorders
  • Chronic/systemic illnesses (i.e., renal failure, rheumatoid arthritis, diabetes, poor lung function, heart disease, cancer, uncontrolled hypertension)
  • Regular consumption of any analgesic or anti-inflammatory drugs. Taking medications mknown to affect muscle metabolis (e.g. beta-blockers, corticosteroids).

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: Ciência básica
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: High Quality Protein
Participants will consume four high-quality protein containing meals per day (amounting to 1g/kg/day of protein) over a 10-day period. Each meal will contain 75:25 animal:plant protein with most of the animal protein from supplemental high-quality protein powder.
Supervised single-leg (unilateral) exercise will be undertaken every other day throughout the dietary intervention
Outros nomes:
  • Single-leg resistance exercise
Participants will consume a protein supplement alongside a provided diet to control protein amount and quality.
Experimental: Low Quality Protein
Participants will consume four low-quality protein containing meals per day (amounting to 1g/kg/day of protein) over a 10-day period. Each meal will contain 25:75 animal:plant protein with most of the plant protein from supplemental low-quality protein powder.
Supervised single-leg (unilateral) exercise will be undertaken every other day throughout the dietary intervention
Outros nomes:
  • Single-leg resistance exercise
Participants will consume a protein supplement alongside a provided diet to control protein amount and quality.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Muscle protein synthesis using muscle biopsies and deuterated water enrichment.
Prazo: 0-10 days
Muscle protein synthesis will be assessed during the high-quality and low-quality intervention and compared between exercised and controlled leg.
0-10 days
Leg Strength using dynamometry
Prazo: 0-10 days
Evaluating change in leg strength, of trained leg, pre- and post-intervention with high-quality and low-quality protein condition
0-10 days
Neural activation using interpolated twitch
Prazo: 0-10 days
Assessing change in neural activation via non-invasive interpolated twitch technique of between exercised legs pre-and post intervention in both protein quality conditions
0-10 days
Muscle architecture using ultrasound
Prazo: 0-10 days
Using non-invasive ultrasound to determine change of muscle structure with training between protein quality conditions.
0-10 days

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Appetite regulation using questionnaires
Prazo: 0-10 days (3 hours postprandial)
Assessing perceived hunger using a validated, 8 question, 100mm visual analogue scales.
0-10 days (3 hours postprandial)
Appetite regulation, blood
Prazo: 0-10 days (3 hours postprandial)
Assessing the secretion of hunger and appetite hormones within the blood after meals which contain high-quality versus low-quality protein.
0-10 days (3 hours postprandial)
Metabolic rate, metabolic cart
Prazo: 0-10 days
Evaluating alterations in energy expenditure before and after high-quality or low-quality protein containing meal using a metabolic cart.
0-10 days
Nitrogen balance from urine and dietary protein intake
Prazo: 0-10 days (24-hour urine collection)
Evaluating change in nitrogen balance between adhering to high-quality or low-quality protein diets over a 10-day period
0-10 days (24-hour urine collection)
Body composition using Duel- energy x-ray absorptiometry (DXA) scan.
Prazo: 0-10 days
Change in body composition (muscle mass, fat mass, bone mineral density) will be evaluated using a DXA scanner before and after adhering to single leg resistance exercise paired with either high-quality or low-quality protein diet.
0-10 days
Muscle fibre specific analysis using immunofluorescence microscopy.
Prazo: 0-10 days
Evaluate changes in fibre specific differences in the distribution and localisation of key anabolic markers between trained and untrained legs for both protein quality conditions.
0-10 days
Intramuscular signalling using western blotting
Prazo: 0-10 days
Evaluate changes in protein content and phosphorylation from the start to the end of the intervention.
0-10 days
Physical activity levels using accelerometery and pedometer
Prazo: -5-10 days
Monitoring of habitual and habitual physical activity to evaluate if intensity and duration of activity is similar between habitual and intervention.
-5-10 days

Colaboradores e Investigadores

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

Colaboradores

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 (Antecipado)

1 de novembro de 2022

Conclusão Primária (Antecipado)

1 de outubro de 2023

Conclusão do estudo (Antecipado)

1 de dezembro de 2023

Datas de inscrição no estudo

Enviado pela primeira vez

29 de setembro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de outubro de 2022

Primeira postagem (Real)

10 de outubro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de outubro de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de outubro de 2022

Última verificação

1 de setembro de 2022

Mais Informações

Termos relacionados a este estudo

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

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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