- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04720950
The Impact of Morning or Evening Exercise on Food Intake (TIME-Ex-Ulster)
The Impact of Morning or Evening Exercise on Total Energy Intake and Food Preference in Non-Exercising Adults.
The beneficial effects of regular exercise on both physical and mental health are widely known; it is a pivotal component in the treatment and prevention of many metabolic disorders, including obesity. Exercise facilitates weight management, not only by increasing energy expenditure but through its effect on appetite regulation and, therefore, energy intake.
Multiple factors influence the effect of exercise on appetite regulation including body fat , gender, intensity and duration of exercise and levels of habitual physical activity . However, recently interest has grown around the impact time-of-day of exercise may have on appetite regulation . Subjective feelings of hunger follow a strong diurnal pattern, with feelings of hunger peaking in the evening and appearing lowest in the morning . Evening energy intake has been associated with increased total energy intake and body mass index Evening exercise could potentially counteract or lessen the evening hunger sensations and therefore reduce evening and total energy intake. The aim of this study is to investigate any changes in total energy intake, distribution of energy intake, and food preference on the day of and 24 -hours after a bout of moderate-intensity exercise completed in the morning or evening in a group of physically inactive adults. A total sample of 12 physically inactive adults aged 18-60 will be recruited on to the study. The study will take the form of a two-armed randomised controlled crossover trial consisting of two 48-hr overnight stays in the Human Intervention Studies Unit (HISU) at Ulster University, Coleraine, Northern Ireland. The participant information sheet will focus on the effect of morning and evening exercise on ambulatory blood pressure and exercise-induced feeling states to prevent the participants' knowledge of the true purpose of the study from influencing their feeding behaviours. Ambulatory blood pressure will be monitored for at least 24 hours after the exercise session and participants will be asked to complete questionnaires of exercise induced feeling states immediately before and after each exercise session. Participants will be briefed on the true purpose of the study following the study completion. During the visits, participants will be asked to perform 1 hour of exercise at 70% of their maximal heart rate on a motorised treadmill between either 0800-1000 or 1800-2000 on the first full day of the study appointment. Food will be provided ad libitum for the duration of the study. All food intake will be noted and covertly weighed and directly observed through security cameras in the HISU dining room and lounge areas to measure food-related behaviours, such as grazing or bingeing. A 24 hour dietary recall will be conducted at the end of each study appointment to validate recall against observed intake.
Visão geral do estudo
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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N.Ireland
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Coleraine, N.Ireland, Reino Unido, BT52 1SA
- Recrutamento
- Human Intervention Studies Unit
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Contato:
- Ruth K Price
- Número de telefone: +442870123878
- E-mail: rk.price@ulster.ac.uk
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Contato:
- Julie J Sittlington
- Número de telefone: +442870124101
- E-mail: jj.sittlington@ulster.ac.uk
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Does not exercise regularly (as determined by International Physical Activity Questionnaire (IPAQ) short form.
- Able to perform 1 hour of moderate-intensity exercise on a treadmill.
Exclusion Criteria:
- Pregnancy/ lactation.
- Have significant dysphagia, gastric outlet obstruction, or any other factor which prevents the consumption of a meal.
- Have a significant food allergy or dietary restriction.
- Have a systemic or gastrointestinal condition that may affect food intake or preference.
- Taking medication or supplements that affect energy intake or appetite.
- Taking medication that affects blood pressure or heart rate.
- Have an irregular sleep or shift work patterns.
- Travel across > one time zone in the last month.
- Fitted with pacemaker
- Smokes or uses vaping products
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Morning exercise
1 hour of exercise completed between 0800-1000
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1 hour of exercise on a motorised treadmill at 70% maximal heart rate
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Experimental: Evening exercise
1 hour of exercise completed between 1800-2000
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1 hour of exercise on a motorised treadmill at 70% maximal heart rate
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Total energy intake
Prazo: Over 48 hours
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Covertly weighed food intake (kJ/day)
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Over 48 hours
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Distribution of energy intake across the day
Prazo: Over 48 hours
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Covertly weighed food intake (kJ/eating epochs)
|
Over 48 hours
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|
Percentage energy intake from macronutrients
Prazo: Over 48 hours
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% energy intake from fat, total carbohydrates, sugar, protein and fibre
|
Over 48 hours
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Basal metabolic rate
Prazo: Over 8 minutes after waking
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By indirect calorimetry
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Over 8 minutes after waking
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Ambulatory blood pressure
Prazo: Over 24 hours
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Measured using Spacelabs 90217 ambulatory monitors
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Over 24 hours
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Exercise induced feelings state.
Prazo: Change over 1 hour (pre exercise to post exercise)
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Measured using The Exercise Induced Feeling Inventory (EFI)
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Change over 1 hour (pre exercise to post exercise)
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Validation of 24 hour dietary recall against observed intake
Prazo: Over 48 hours
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Direct comparison between observed and reported food intake (kJ, % energy contribution from macronutrients)
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Over 48 hours
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- FCBMS-20-061
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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