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Influence of Prior Walking on Postprandial Metabolism in Centrally Obese Men

27 de janeiro de 2020 atualizado por: Matthew Roberts, Loughborough University

Influence of Prior Walking on Endothelial Function and Coronary Heart Disease Risk Markers in Centrally Obese South Asian and White European Men

The present study will investigate the effect of prior walking on postprandial metabolism and endothelial function in centrally obese South Asian and White European men.

Participants will complete two, 2-day trials in a random, crossover design separated by at least a week.

On day 1, participants will either rest or complete a 60 minute walk at 60% maximal oxygen uptake. On day 2, participants will arrive at 08:00 having fasted overnight and a baseline venous blood sample and endothelial function measurement will be taken. Participants will consume a high-fat breakfast and lunch and 12 subsequent venous blood samples will be taken throughout the day at standardised intervals to measure a variety of coronary heart disease risk markers. A second endothelial function measurement will be completed 2 hours after the breakfast. Blood pressure will be measured every hour.

It is expected that the South Asian participants will have impaired metabolism and endothelial function compared to their European counterparts but the bout of exercise performed on day 1 will mitigate these responses.

Visão geral do estudo

Descrição detalhada

South Asians have a higher-than-average risk of coronary heart disease. The reasons for this are unclear, but physical inactivity and/or poor responsiveness to exercise may play a role. It is important to understand the effect of exercise on endothelial function and coronary heart disease risk markers in the hope that exercise can be prescribed as an effective treatment to mitigate endothelial dysfunction and the risk of heart disease.

Previous research from the investigators' laboratory has indicated that postprandial metabolism is impaired in South Asian men, but this, and other coronary heart disease risk markers, can be improved with acute exercise. However, the previous research was conducted in apparently healthy South Asian and White European men. The investigators now wish to quantify and compare the coronary heart disease risk marker and endothelial function response to acute exercise in centrally obese South Asian and White European individuals who are at a higher risk for diabetes and cardiovascular disease.

On visit 1, participants will attend the laboratory to undergo preliminary assessments and to be familiarised with the laboratory environment and study procedures. Specifically, health status, habitual physical activity, dietary habits and anthropometric data (height, weight, waist and hip circumference, body fat) will be collected. A HbA1c test will be performed to check participants are not diabetic. The modified Bruce Treadmill test will be performed to predict maximal oxygen uptake.

On visit 2, participants will undergo a magnetic resonance imaging (MRI) scan to quantify regional body composition comprising abdominal subcutaneous adipose tissue, visceral adipose tissue, liver fat percentage, thigh intramuscular adipose tissue and thigh muscle volume.

On visits 3-6 participants will complete two, 2-day trials in a random, crossover design separated by at least 1 week. On day 1 of both trials, participants will arrive fasted at 08:00 and a baseline blood sample, blood pressure and endothelial function measurement will be taken. Participants will consume a standardised high fat breakfast at 09:00 and lunch at 13:00. At 15:30 the participants will walk for 60 minutes at 60% maximal oxygen uptake and complete a second endothelial function measurement at 16:45. Participants will leave the laboratory with a standardised evening meal to consume before 22:00. The control trial will be the same, except no exercise will be performed.

On day 2, participants will arrive at 08:00 having fasted overnight for 10h (except plain water). A cannula will be inserted into the antecubital vein for collection of venous blood samples. Blood pressure will be measured at 08:00 (0h) and again at hourly intervals throughout the day. Endothelial function will measured at 08:15 (0.25h) and again at 3h. At 0h, a fasting blood sample will be collected. Subsequent venous blood samples will be collected at 1.5, 1.75, 2, 3, 4, 5, 5.5, 5.75, 6, 7, 8 and 9h. Participants will consume a standardised high fat breakfast at 1h and a standardised high fat lunch at 5h. The meals consist of 57% fat, 32% carbohydrate and 11% protein. The meals provide 14.3 kcal per kg of body mass.

Participants will rest in the laboratory throughout day 2 of both the exercise and control trials.

Tipo de estudo

Intervencional

Inscrição (Real)

30

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

      • Loughborough, Reino Unido, LE11 3TU
        • National Centre for Sport and Exercise Medicine, Loughborough University

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

18 anos a 60 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Macho

Descrição

Inclusion Criteria:

  • 18 to 60 year old South Asian and White European men;
  • Centrally obese (waist circumference >90cm for South Asians, >94cm for White Europeans);
  • Weight stable for the past 3 months;
  • Non-smokers;
  • No known contradictions to maximal exertion exercise.

Exclusion Criteria:

  • Musculoskeletal injury that has affected normal ambulation within the last month;
  • Congenital heart disease;
  • Any muscle or bone injuries that do not allow them to walk on a treadmill;
  • Uncontrolled exercise-induced asthma;
  • Coagulation or bleeding disorders;
  • Diabetes (metabolism will be different to non-diabetics potentially skewing the data);
  • Taking any medication that might influence fat metabolism;
  • Taking any medication that might influence blood glucose (e.g., insulin for diabetes);
  • Heart conditions;
  • Smoking;
  • Dieting or restrained eating behaviours;
  • Weight fluctuation greater than 3 kg in the previous 3 months to study enrolment;
  • A food allergy.

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: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Experimental: Exercise
Exercise: Participants will walk for 60 minutes at 60% maximal oxygen uptake on day 1.
Uma caminhada de 60 minutos com consumo máximo de oxigênio de 60%.
Sem intervenção: No Intervention: Control
Participants will rest on day 1.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Triacylglycerol changes in response to exercise and feeding
Prazo: Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 1.75hours, 2hours, 3hours, 4hours, 5hours, 5.5hours, 5.75hours, 6hours, 7hours, 8hours and 9hours.
Fasting on day 1 and 2. Time-course of plasma triacylglycerol concentrations in response to exercise and/or feeding on day 2.
Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 1.75hours, 2hours, 3hours, 4hours, 5hours, 5.5hours, 5.75hours, 6hours, 7hours, 8hours and 9hours.
Endothelial function changes in response to exercise and feeding
Prazo: Day 1 fasting and 8.75hours. Day 2 fasting and 2.5hours.
Changes in endothelial function via flow-mediated dilatation in response to feeding and exercise.
Day 1 fasting and 8.75hours. Day 2 fasting and 2.5hours.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Colesterol total
Prazo: Jejum do 1º dia. Jejum do 2º dia.
Colesterol total plasmático em jejum no dia 1 e no dia 2 de ambos os ensaios.
Jejum do 1º dia. Jejum do 2º dia.
Colesterol de lipoproteína de alta densidade
Prazo: Jejum do 1º dia. Jejum do 2º dia.
Colesterol de lipoproteína de alta densidade em jejum no dia 1 e 2 de ambos os ensaios.
Jejum do 1º dia. Jejum do 2º dia.
Colesterol de lipoproteína de baixa densidade
Prazo: Jejum do 1º dia. Jejum do 2º dia.
Colesterol de lipoproteína de baixa densidade em jejum no dia 1 e 2 de ambos os ensaios.
Jejum do 1º dia. Jejum do 2º dia.
Glucose changes in response to exercise and/or feeding
Prazo: Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 1.75hours, 2hours, 3hours, 4hours, 5hours, 5.5hours, 5.75hours, 6hours, 7hours, 8hours and 9hours.
Fasting on day 1 and 2. Time-course of plasma glucose concentrations in response to exercise and/or feeding on day 2.
Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 1.75hours, 2hours, 3hours, 4hours, 5hours, 5.5hours, 5.75hours, 6hours, 7hours, 8hours and 9hours.
Blood pressure changes in response to exercise and/or feeding
Prazo: Day 1 fasting. Day 2 fasting (0 hour point) and 1hours, 2hours, 3hours, 4hours, 5hours, 6hours, 7hours, 8hours and 9hours.
Changes in blood pressure (systolic and diastolic).
Day 1 fasting. Day 2 fasting (0 hour point) and 1hours, 2hours, 3hours, 4hours, 5hours, 6hours, 7hours, 8hours and 9hours.
Insulin changes in response to exercise and/or feeding
Prazo: Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 2hours, 4hours, 5hours, 5.5hours, 7hours, 8hours.
Fasting on day 1 and 2. Time-course of plasma insulin concentrations in response to exercise and/or feeding on day 2.
Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 2hours, 4hours, 5hours, 5.5hours, 7hours, 8hours.
Non-esterified fatty acids changes in response to exercise and/or feeding
Prazo: Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 2hours, 4hours, 5hours, 5.5hours, 7hours and 9hours.
Fasting on day 1 and 2. Time-course of plasma non-esterified fatty acid concentrations in response to exercise and/or feeding on day 2.
Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 2hours, 4hours, 5hours, 5.5hours, 7hours and 9hours.
Interleukin-6 changes in response to exercise and/or feeding
Prazo: Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
Fasting on day 1 and 2. Time-course of plasma interleukin-6 concentrations in response to exercise and/or feeding on day 2.
Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
C-Reactive protein changes in response to exercise and/or feeding
Prazo: Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
Fasting on day 1 and 2. Time-course of plasma C-Reactive protein concentrations in response to exercise and/or feeding on day 2.
Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
Tumor Necrosis Factor concentrations
Prazo: Day 1 fasting. Day 2 fasting.
Fasting tumor necrosis factor on day 1 and 2 of both trials.
Day 1 fasting. Day 2 fasting.
Peroxiredoxin-4 changes in response to exercise and/or feeding
Prazo: Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
Fasting on day 1 and 2. Time-course of plasma peroxiredoxin-4 concentrations across day 2 of both trials.
Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
Superoxide dismutase 3
Prazo: Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
Fasting on day 1 and 2. Time-course of plasma Superoxide dismutase 3 concentrations across day 2 of both trials
Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.

Colaboradores e Investigadores

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Publicações e links úteis

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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)

3 de janeiro de 2019

Conclusão Primária (Real)

1 de setembro de 2019

Conclusão do estudo (Real)

1 de setembro de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

13 de maio de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de maio de 2019

Primeira postagem (Real)

16 de maio de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de janeiro de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de janeiro de 2020

Última verificação

1 de janeiro de 2020

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Anonymised individual participant data for all primary and secondary outcome measures will be made available upon request. Study protocol, statistical analysis plan and informed consent forms are also available upon request.

Prazo de Compartilhamento de IPD

The data will become available in 6 months after publication for 1 year.

Critérios de acesso de compartilhamento IPD

Data will be available to other researchers who would like to run the same statistical methods we have used to check the interpretation of results.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF

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