- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Copenhagen, Danemark, 1958
- Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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
Autres noms:
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Comparateur 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
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Energy expenditure
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Spontaneous energy intake
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Arne Astrup, MD, PhD, Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
- Chercheur principal: Anders M Sjödin, MD, PhD, Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- OPUS-B261
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