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Effects of Impaired Sleep on Energy Balance (SLOPUS)

9 de agosto de 2011 atualizado por: University of Copenhagen

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

Status

Concluído

Condições

Intervenção / Tratamento

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

Intervencional

Inscrição (Real)

21

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

      • Copenhagen, Dinamarca, 1958
        • Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen

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

15 anos a 19 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Macho

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

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: 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.)
Duration of sleep per night
Outros nomes:
  • Sleep curtailment, acute sleep deprivation
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.)
Duration of sleep per night
Outros nomes:
  • Sleep curtailment, acute sleep deprivation

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
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.
Over the course of 24 hours on day 3

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
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.
Measured after a maximum of 30 minutes meal time on day 1 and day 4
Spontaneous physical activity
Prazo: 24 hours for 3 consecutive days
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
24 hours for 3 consecutive days
Appetite regulating hormones and stress hormones
Prazo: Measured every half hour over the course of 4 hours on day 1 and day 4
Hormones are sampled from blood, saliva, and urine.
Measured every half hour over the course of 4 hours on day 1 and day 4
Hunger and desire to eat
Prazo: Measured every hour or half hour over the course of 9 hours on day 1 and day 4
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.
Measured every hour or half hour over the course of 9 hours on day 1 and day 4
Stress hormone (cortisol)
Prazo: Measured at 7 am and 7.30 am on day 1 and day 4
Hormones are sampled saliva.
Measured at 7 am and 7.30 am on day 1 and day 4

Colaboradores e Investigadores

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

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

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Links úteis

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

1 de outubro de 2009

Conclusão Primária (Real)

1 de fevereiro de 2011

Conclusão do estudo (Real)

1 de fevereiro de 2011

Datas de inscrição no estudo

Enviado pela primeira vez

8 de setembro de 2010

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de setembro de 2010

Primeira postagem (Estimativa)

10 de setembro de 2010

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

10 de agosto de 2011

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de agosto de 2011

Última verificação

1 de setembro de 2010

Mais Informações

Termos relacionados a este estudo

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 .

Ensaios clínicos em Sleep duration

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