- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01198431
Effects of Impaired Sleep on Energy Balance (SLOPUS)
Effects of Impaired Sleep on Energy Balance: A Randomized, 2-Condition, Crossover Study in Adolescents
The main aim of this study is to examine the effects of restricted sleep on energy and substrate metabolism as well as relevant hormonal systems that might be involved in the underlying mechanisms.
The investigators hypothesize that short-term sleep curtailment in adolescents is accompanied by 1) increased hunger and desire to eat; 2) increased spontaneous energy intake; 3) reduced spontaneous physical activity; and 4) increased fluctuation in hormones in a way that could favour a positive energy balance and potentially weight gain on the long run.
Visão geral do estudo
Descrição detalhada
The background for this project is that despite considerable knowledge of the mechanisms regulating body weight, the prevalence of obesity has not declined. The individual and environmental factors that play a part in energy balance are still not completely understood, and current methods for loosing and maintaining body weight are generally unsuccessful. Knowledge about what brings about changes in metabolism and lifestyle is lacking.
Reduced sleep duration has been observed in parallel with increases in body weight. Lack of sleep has become a hallmark of modern man, and both children and adults sleep less today than just a few decades ago. Research suggests that both too much and too little sleep can lead to obesity, but correlations between sleep deprivation and other lifestyle-related ailments have also been observed. The reasons for these correlations are far from clear, especially in children and adolescents.
The main purpose of SLOPUS is to investigate the effects of reduced sleep on energy and substrate metabolism, and the relevant hormonal systems involved in the underlying mechanisms. Our hypothesis is that acute sleep deprivation in teenagers leads to increased hunger and desire to eat, increased spontaneous energy intake, decreased spontaneous physical activity, and increased fluctuation in the hormones that control energy metabolism.
The investigators aim to recruit twenty-four healthy, normal weight boys aged 15-19 years with normal sleep pat-terns. The study will be conducted as a randomized, crossover study with two conditions. Each participant will be subjected to short sleep (4 hours) and normal sleep (9 hours), in random order, for three consecutive nights in a respiration chamber. They will stay in the chamber for the 24 hours before the last night. In the respiration chamber energy turnover is measured - both how much energy and also the type of substrate combusted. The chamber is equipped with a bed, toilet, television, computer, and communication. Food and drink can be supplied via an airlock. Measurements in the chamber include volitional activities and sleep duration/quality.
Energy turnover will be measured using a ventilated hood system on the first and last day. Here the participants lie down on a bed with their heads under a transparent canopy for 25-minute intervals during the morning. Blood samples will also be taken during these periods. Meal tests will be served, where we measure the amount of food ingested, and subjects will be given questionnaires about hunger and satiety to fill out. Physical activity and heart rate will be measured throughout the trial.
Thus, the present study is likely to result in a number of new and important findings regarding the impact of impaired sleep on energy balance and it might improve the recommendations for optimal sleep in adolescents.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Copenhagen, Dinamarca, 1958
- Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
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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:
- normal weight (5th percentile to less than the 85th percentile)
Exclusion Criteria:
- self-reported sleep problems (Pittsburgh Sleep Quality Index score >5);
- night work;
- variable sleep habits or habitual daytime naps;
- regular physical exercise (>3 hours/week);
- excessive intake of alcohol (>7 drinks/week);
- excessive intake of caffeine (>300 mg/day);
- smoking;
- substance abuse;
- use of prescription medications or over-the-counter drugs affecting sleep or metabolism;
- chronic diseases (e.g. cancer, asthma, back pain, thyroid disease, heart disease, diabetes, etc.)
- history of neurological, medical or sleep disorders;
- trans-meridian travelling the last month;
- eating disorder;
- irregular eating schedule (e.g. skipping breakfast);
- unable to comply with the protocol.
Plano de estudo
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 |
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Experimental: Sleep restriction
Each participant will be engaged in three consecutive nights of 4 hours of sleep per night (from 3.00 a.m. to 7.00 a.m.)
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Duration of sleep per night
Outros nomes:
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Comparador de Placebo: Normal sleep duration
Each participant will be engaged in three consecutive nights of 9 hours of sleep per night (from 10.00 p.m. to 7.00 a.m.)
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Duration of sleep per night
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Energy expenditure
Prazo: Over the course of 24 hours on day 3
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Energy expenditure and substrate oxidation rate will be assessed by 24-hour indirect whole-body calorimetry (respiration chamber) on the basis of measurements of oxygen consumption, carbon dioxide production, and nitrogen excretion in urine.
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Over the course of 24 hours on day 3
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Spontaneous energy intake
Prazo: Measured after a maximum of 30 minutes meal time on day 1 and day 4
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In an attempt to measure spontaneous energy intake in an experimental context, the participant will be given an ad libitum lunch at noon.
The ad libitum meal is a homogenous meal with a macronutrient composition of: 15 E%; fat: 30 E%; carbohydrate: 55 E%.The portion of pasta is larger than the expected participant's intake.
The meal will be weighted before and after the lunch and ad libitum energy intake is assessed from the amount of the meal consumed by a food technician.
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Measured after a maximum of 30 minutes meal time on day 1 and day 4
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Spontaneous physical activity
Prazo: 24 hours for 3 consecutive days
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Spontaneous physical activity is measured by a wrist worn actigrpahy device during the three days of intervention.
Moreover, spontaneous activity in the respiration chamber will be assessed by in-biuld microwave radar detectors
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24 hours for 3 consecutive days
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Appetite regulating hormones and stress hormones
Prazo: Measured every half hour over the course of 4 hours on day 1 and day 4
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Hormones are sampled from blood, saliva, and urine.
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Measured every half hour over the course of 4 hours on day 1 and day 4
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Hunger and desire to eat
Prazo: Measured every hour or half hour over the course of 9 hours on day 1 and day 4
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Hunger and desire to eat is measured using visual analogue scales before and after a standardized breakfast meal challange and before and after an ad libitum meal.
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Measured every hour or half hour over the course of 9 hours on day 1 and day 4
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Stress hormone (cortisol)
Prazo: Measured at 7 am and 7.30 am on day 1 and day 4
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Hormones are sampled saliva.
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Measured at 7 am and 7.30 am on day 1 and day 4
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Arne Astrup, MD, PhD, Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
- Investigador principal: Anders M Sjödin, MD, PhD, Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- OPUS-B261
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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