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van CCT (UK)

van CCT (UK)

One night of partial sleep restriction: effects on metabolism, mood, and stress responsiveness

- candidate number24201
- NTR NumberNTR5824
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-apr-2016
- Secondary IDsProtocol-ID P15.353 ABR dossiernummer NL55111.058.15
- Public TitleOne night of partial sleep restriction: effects on metabolism, mood, and stress responsiveness
- Scientific TitleOne night of partial sleep restriction: effects on metabolism, mood, and stress responsiveness
- hypothesisWe hypothesize that a single night of short sleep duration (4 hours), compared to normal sleep duration (8 hours) reduces metabolic flexibility, increases insulin resistance and thereby reduces HPA-reactivity. Furthermore, we hypothesize that a single night of short sleep will negatively affect mood and tissue ageing due to dysregulation of HPA-axis. Since BMI is correlated with metabolic inflexibility and insulin resistance, we hypothesize that individuals with a higher BMI will show a more detrimental effect of short sleep on metabolism, HPA-axis reactivity and downstream effects on mood and tissue ageing, than individuals with a lower BMI.
- Healt Condition(s) or Problem(s) studiedSleep, Metabolism, Mood, Stress
- Inclusion criteria- Informed consent
- Male Caucasian
- Age between 18 and 55 years
- BMI between 20 and 35 kg/m2
- Exclusion criteria- Active endocrine disease (e.g. diabetes mellitus type 1 and type 2, thyroid disease, any signs of Cushing’s syndrome, adrenal disease and lipid-associated disorders such as FH)
- Fasting glucose >7.0 mmol/L
- Severe chronic disease (e.g. chronic liver or kidney disease)
- Severe insomnia, sleep disorders or exceptional habitual sleep duration (<6 or >10 h).
- Medication use including the following: lipid lowering drugs, glucocorticoids, sleep medication, hormone replacement, glucose lowering drugs, insulin therapy, antidepressants and psychotropic drugs (last 6 weeks)), anti-coagulants
- Recent time zone travel (last 6 weeks)
- Shift work (last 6 weeks)
- Severe alcohol use (>21 units/week)
- Psychiatric disease
- Drug abuse
- Recent participation to another nutritional or biomedical trial (last 6 weeks)
- Medication use which may interfere with study measurements, as judged by the responsible physician
- Reported weight loss or weight gain (10%) in the last six months prior to the pre-study screening
- Clinically relevant abnormalities in clinical chemistry at screening (to be judged by the study physician)
- Reported use of any nicotine containing products in the six months preceding the study and during the study itself;
- Extreme strenuous exercise during last 3 months, as judged by responsible physician
- Excessive sunbathing during last 3 months, as judged by responsible physician.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mei-2016
- planned closingdate30-apr-2017
- Target number of participants36
- InterventionsOne night of short sleep (4h) will be compared to one night of normal sleep (8h).
- Primary outcome- Metabolic flexibility; measured as change in RQ and lipid levels after a standard meal
- Stress responsiveness; measured as change in stress hormones, heart rate and blood pressure after a mild physical stressor
- Secondary outcome- Tissue ageing; measured in skin
- Intracellular metabolic pathways; measured in subcutaneous white fat and skeletal muscle tissue
- Circadian rhythm in hormone and skin temperature rhythms
- TimepointsOutcome parameters will be measured on the day immediately following the sleep intervention.
- Trial web site
- status[default]
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsDonga,E., van,D.M., van Dijk,J.G., Biermasz,N.R., Lammers,G.J., van Kralingen,K.W., Corssmit,E.P., and Romijn,J.A. (2010a). A single night of partial sleep deprivation induces insulin resistance in multiple metabolic pathways in healthy subjects. J Clin Endocrinol. Metab 95, 2963-2968. Donga,E., van,D.M., van Dijk,J.G., Biermasz,N.R., Lammers,G.J., van,K.K., Hoogma,R.P., Corssmit,E.P., and Romijn,J.A. (2010b). Partial sleep restriction decreases insulin sensitivity in type 1 diabetes. Diabetes Care 33, 1573-1577.
- Brief summaryIn modern daily life, incidental short sleep duration has become a common feature. Chronic short sleep duration is associated with a many adverse health effects, including metabolic disturbances such as obesity, type 2 diabetes and cardiovascular diseases, as well as disturbances in the stress system, negative mood and tissue ageing. These associations may be explained by metabolic disturbances caused by repeated incidental short sleep duration.
This study aims to investigate the effects of a single night of short sleep on metabolism, mood and stress responsiveness. To this end, we will include healthy participants in a cross-over intervention trial and subjects participants to both short and normal sleep.
- Main changes (audit trail)
- RECORD6-apr-2016 - 22-jun-2016

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