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ObesitySLOPUSNCT01198431

Effects of Impaired Sleep on Energy Balance

A study testing Sleep duration in people with Obesity and Sleep, run by University of Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 19 years, men onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Sleep
What is being tested?
Sleep duration
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
1 siteDenmark
Study dates
Oct 2009to Feb 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 19 years
  • Men only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Department of Human Nutrition, Faculty of LIFE Sciences, University of Copenhagen

    Copenhagen, 1958

Other trials in Denmark

About this study

Official title: 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.

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.

Conditions
Obesity, Sleep
Being tested
Sleep duration
Keywords
Appetite regulation, Physical activity, Energy balance
Medical subject headings
Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleep durationBehavioural

    Also called Sleep curtailment, acute sleep deprivation

    Duration of sleep per night

Study groups in NCT01198431
Study groupRoleWhat they receive
Sleep restrictionExperimentalEach 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.)
Receives: Behavioral: Sleep duration
Normal sleep durationPlacebo comparatorEach 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.)
Receives: Behavioral: Sleep duration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Over the course of 24 hours on day 3

Secondary outcomes (5)
  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.

    Measured: 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

    Measured: 24 hours for 3 consecutive days

  3. Appetite regulating hormones and stress hormones

    Hormones are sampled from blood, saliva, and urine.

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2010 (estimated)
  2. Study startOct 2009
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01198431
Sponsor's protocol ID
OPUS-B261
Acronym
SLOPUS
Status last verified
Sep 2010
First submitted
8 Sep 2010
Last updated
10 Aug 2011
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Sleep duration in people with Obesity and Sleep, run by University of Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Energy expenditure (time frame: Over the course of 24 hours on day 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01198431, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2011.

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