NCT01198431

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

August 10, 2011

Status Verified

September 1, 2010

Enrollment Period

1.3 years

First QC Date

September 8, 2010

Last Update Submit

August 9, 2011

Conditions

ObesitySleep

Keywords

Appetite regulationPhysical activityEnergy balance

Outcome Measures

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.

    Over the course of 24 hours on day 3

Secondary Outcomes (5)

  • Spontaneous energy intake

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

  • Spontaneous physical activity

    24 hours for 3 consecutive days

  • Appetite regulating hormones and stress hormones

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

  • Hunger and desire to eat

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

  • Stress hormone (cortisol)

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

Study Arms (2)

Sleep restriction

EXPERIMENTAL

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

Normal sleep duration

PLACEBO COMPARATOR

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

Sleep durationBEHAVIORAL

Duration of sleep per night

Also known as: Sleep curtailment, acute sleep deprivation
Normal sleep durationSleep restriction

Eligibility Criteria

Age15 Years - 19 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition, Faculty of LIFE Sciences, University of Copenhagen

Copenhagen, 1958, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 22760574DERIVED

Related Links

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Sleep Duration

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

SleepNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Arne Astrup, MD, PhD

    Department of Human Nutrition, Faculty of LIFE Sciences, University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Anders M Sjödin, MD, PhD

    Department of Human Nutrition, Faculty of LIFE Sciences, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2010

First Posted

September 10, 2010

Study Start

October 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

August 10, 2011

Record last verified: 2010-09

Locations

DK(1)