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Effects of Impaired Sleep on Energy Balance (SLOPUS)

9. august 2011 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

21

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

15 år til 19 år (Barn, Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Andre navne:
  • Sleep curtailment, acute sleep deprivation
Placebo komparator: 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
Andre navne:
  • Sleep curtailment, acute sleep deprivation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Energy expenditure
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Spontaneous energy intake
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Arne Astrup, MD, PhD, Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
  • Ledende efterforsker: Anders M Sjödin, MD, PhD, Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2009

Primær færdiggørelse (Faktiske)

1. februar 2011

Studieafslutning (Faktiske)

1. februar 2011

Datoer for studieregistrering

Først indsendt

8. september 2010

Først indsendt, der opfyldte QC-kriterier

9. september 2010

Først opslået (Skøn)

10. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. august 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. august 2011

Sidst verificeret

1. september 2010

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • OPUS-B261

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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