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CompletedNCT01198431SLOPUSUpdated Aug 10, 2011

Effects of Impaired Sleep on Energy Balance

An interventional study of Sleep duration in Obesity and Sleep, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to male participants aged 15 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-08-10.

Sponsored by University of Copenhagen · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
15 Years to 19 Years
Sex
Male
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Obesity
  • Sleep

Keywords

  • Appetite regulation
  • Physical activity
  • Energy balance
03

In context

Lead sponsor

University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 19 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • normal weight (5th percentile to less than the 85th percentile)

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • 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.)

    Behavioral: Sleep duration

  • Placebo comparator
    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.)

    Behavioral: Sleep duration

Interventions

  • BehavioralSleep duration

    Duration of sleep per night

    Also known as: Sleep curtailment, acute sleep deprivation

06

What researchers measure

Primary outcomes

  1. Energy expenditure

    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.

    Time frame: Over the course of 24 hours on day 3

Secondary outcomes

  1. Spontaneous energy intake

    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.

    Time frame: Measured after a maximum of 30 minutes meal time on day 1 and day 4

  2. Spontaneous physical activity

    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

    Time frame: 24 hours for 3 consecutive days

  3. Appetite regulating hormones and stress hormones

    Hormones are sampled from blood, saliva, and urine.

    Time frame: Measured every half hour over the course of 4 hours on day 1 and day 4

  4. Hunger and desire to eat

    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.

    Time frame: Measured every hour or half hour over the course of 9 hours on day 1 and day 4

  5. Stress hormone (cortisol)

    Hormones are sampled saliva.

    Time frame: Measured at 7 am and 7.30 am on day 1 and day 4

07

Study locations

1 site
  • Department of Human Nutrition, Faculty of LIFE Sciences, University of Copenhagen
    Copenhagen, 1958, Denmark
08

References and documents

Publications

  • Klingenberg L, Chaput JP, Holmback U, Jennum P, Astrup A, Sjodin A. Sleep restriction is not associated with a positive energy balance in adolescent boys. Am J Clin Nutr. 2012 Aug;96(2):240-8. doi: 10.3945/ajcn.112.038638. Epub 2012 Jul 3. PubMed 22760574 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01198431
Lead sponsor
University of Copenhagen
First posted
Sep 10, 2010
Start date
Oct 2009
Primary completion
Feb 2011
Completion
Feb 2011
Last update
Aug 10, 2011

Study contacts

Arne Astrup, MD, PhD
principal investigator · Department of Human Nutrition, Faculty of LIFE Sciences, University of Copenhagen
Anders M Sjödin, MD, PhD
principal investigator · Department of Human Nutrition, Faculty of LIFE Sciences, University of Copenhagen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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