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The Effect of Tea Breaks on Cerebrovascular Perfusion During Desk Work

6 de agosto de 2019 atualizado por: Unilever R&D
Sedentary behaviour of healthy subjects may have a detrimental impact on cerebral blood flow as well as cognitive measures related to mood and alertness. In this study we focus on the impact of leaving the desk to consume a cup of tea at regular intervals during a sedentary working day.

Visão geral do estudo

Status

Concluído

Intervenção / Tratamento

Descrição detalhada

Prolonged desk work has detrimental impact on cerebral blood flow as well as cognitive measures related to mood and alertness caused. These effects might be prevented by taking short breaks with physical activity. Usually, desk workers have short breaks during office times for either a visit to the restroom or to enjoy for a moment a (hot) drink. Consumption of tea has been associated with benefits related to attention, alertness, mood and creativity. This study focuses on the impact of physically leaving the desk to prepare and consume a cup of tea at regular intervals during a sedentary working day.

Tipo de estudo

Intervencional

Inscrição (Real)

20

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

      • Liverpool, Reino Unido
        • John Moores 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

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Healthy males and females, age at screening > 18 and < 60 years;
  • BMI > 18 and < 30 kg/m2
  • Apparently healthy
  • Agreeing to be informed about medically relevant personal test-results by a physician
  • Informed consent signed
  • Sedentary working individuals (≥6 hours desk work per day, ≥4 days per week)

Exclusion Criteria:

  • Reported physical exercise ≥4 hours per week
  • Taking medication (including food supplements and traditional medicines) which may interfere with study measurements, as judged by the PI
  • Reported participation in another nutritional or biomedical trial (involving an intervention of at least 1 week) 3 months before the screening or during the study
  • Reported participation in night shift work 2 weeks prior to screening or during the study. Night work is defined as working between midnight and 6.00 a.m.
  • Reported consumption of > 14 units (female subjects) and > 21 units (male subjects) alcoholic drinks in a typical week.
  • Reported use of any nicotine containing products in the 6 months preceding the study and during the study itself.
  • If female, is pregnant (or has been pregnant during the last < 3 months ago) or will be planning pregnancy during the study period.
  • If female, is lactating or has been lactating in the 6 weeks before screening and/or during the study period.
  • Reported weight loss/gain (> 10%) in the last 6 months before the study.
  • Being an employee of Unilever or an employee or a student working in RISES LJMU that is directly involved in this study.

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: Tea-water
Tea before water
Subjects walk to a nearby area and prepare a cup of 150 ml tea once every hour. The tea is consumed whilst being seated at their desks.
150 ml water is served to subjects once every hour. The water is consumed whilst being seated at their desks.
Experimental: Water-tea
Water before tea
Subjects walk to a nearby area and prepare a cup of 150 ml tea once every hour. The tea is consumed whilst being seated at their desks.
150 ml water is served to subjects once every hour. The water is consumed whilst being seated at their desks.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Difference in cerebrovascular perfusion of tea versus water
Prazo: Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.
Cerebrovascular perfusion measured as middle cerebral artery velocity
Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Difference in cerebrovascular auto-regulation gain of tea versus water
Prazo: Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.

Dynamic cerebrovascular autoregulation is assessed via squat-stand manoeuvres performed to elicit oscillations in blood pressure within the high-pass filter frequency range (<0.20 Hz) of the cerebrovascular. Squat-stand cycles are performed at 0.2 Hz (2.5-seconds squatting, followed by 2.5-seconds standing) and at 0.1 Hz (5-seconds squatting, followed by 5-seconds standing) for 5-minutes each, separated by a 5-minute rest.

Transfer function analysis is conducted on the beat-to-beat blood pressure and middle cerebral artery blood flow velocity mean signals to produce values of gain (damping effect of Cerebrovascular autoregulation on the magnitude of blood pressure oscillations).

Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.
Difference in cerebrovascular auto-regulation phase of tea versus water
Prazo: Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.

Dynamic cerebrovascular autoregulation is assessed via squat-stand manoeuvres performed to elicit oscillations in blood pressure within the high-pass filter frequency range (<0.20 Hz) of the cerebrovascular. Squat-stand cycles are performed at 0.2 Hz (2.5-seconds squatting, followed by 2.5-seconds standing) and at 0.1 Hz (5-seconds squatting, followed by 5-seconds standing) for 5-minutes each, separated by a 5-minute rest.

Transfer function analysis is conducted on the beat-to-beat blood pressure and middle cerebral artery blood flow velocity mean signals to produce values of phase (temporal relationship between changes in blood pressure and middle cerebral artery blood flow velocity).

Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.
Difference in cerebrovascular auto-regulation coherence of tea versus water
Prazo: Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.

Dynamic cerebrovascular auto-regulation is assessed via squat-stand manoeuvres performed to elicit oscillations in blood pressure within the high-pass filter frequency range (<0.20 Hz) of the cerebrovascular. Squat-stand cycles are performed at 0.2 Hz (2.5-seconds squatting, followed by 2.5-seconds standing) and at 0.1 Hz (5-seconds squatting, followed by 5-seconds standing) for 5-minutes each, separated by a 5-minute rest.

Transfer function analysis is conducted on the beat-to-beat blood pressure and middle cerebral artery blood flow velocity mean signals to produce values of coherence (linearity of the relationship between the changes in middle cerebral artery blood flow velocity and blood pressure).

Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Difference in PANAS of tea versus water
Prazo: Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.
Positive and Negative Affect Schedule (PANAS) questionnaire consisting of a list of ten positive and ten negative feelings and emotions. Participants rate the extent to which they are feeling each emotion, on a scale from 1 (very slightly or not at all) to 5 (extremely).
Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.
Difference in Bond-Lader of tea versus water
Prazo: Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.
Bond-Lader questionnaire: 16 adjective pairs with a 100mm line in between. Three sub-scales will be calculated: Alertness, Contentedness and Calmness.
Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.
Difference in affect of tea versus water
Prazo: Before (0) and at 1, 2, 3, 4 and 5 hours during tea and water interventions. Both dimensions will be tested in a repeated measures linear mixed model. The treatment effect is the difference in the least square means of tea versus water.
Affect grid. Two dimensional grid of 19x19 cells scoring pleasure and arousal
Before (0) and at 1, 2, 3, 4 and 5 hours during tea and water interventions. Both dimensions will be tested in a repeated measures linear mixed model. The treatment effect is the difference in the least square means of tea versus water.

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Dick Thijssen, prof, Liverpool John Moores University

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)

30 de abril de 2019

Conclusão Primária (Real)

24 de junho de 2019

Conclusão do estudo (Real)

15 de julho de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

24 de abril 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)

7 de agosto de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de agosto de 2019

Última verificação

1 de agosto de 2019

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • REF-BEV-3235

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

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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