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Het effect van verstoorde circadiane ritmiek en slaapverstoring op voedingspatronen, obesitas en het metabole syndroom.


- candidate number9695
- NTR NumberNTR2926
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jun-2011
- Secondary IDs10-3-030 MEC Unimaas
- Public TitleHet effect van verstoorde circadiane ritmiek en slaapverstoring op voedingspatronen, obesitas en het metabole syndroom.
- Scientific TitleEffects of circadian misalignment and sleep disturbance on feeding patterns, obesity and the metabolic syndrome.
- ACRONYMEffects of circadian misalignment
- hypothesisCircadian misalignment may result in disturbed energy balance, as a consequence of decreased energy expenditure.
- Healt Condition(s) or Problem(s) studiedObesity
- Inclusion criteria1. Healthy, weight stable men and women;
2. A Body Mass Index (BMI) between 20-30 kg/m2;
3. Age of 18-30 years;
4. Evening people.
- Exclusion criteriaExclusion criteria for subjects apart from BMI and age:
1. Smoking;
2. Being on medication (except the use of contraception);
3. Excessive alcohol consumption;
4. Excessive exercise;
5. Not being weight stable;
6. Having sleep problems (such as insomnia, daytime hypersomnia or repeated waking up during the nigjt);
7. Being morning people;
8. Being dietary restraint (assessed by the Three Factor Eating Questionnaire (TFEQ)).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 13-jun-2011
- planned closingdate1-jul-2012
- Target number of participants16
- InterventionsSubjects will stay time blinded in the respiration chamber to measure energy intake and energy expenditure, as well as sleep quality, mood, feelings of hunger and satiety, food choice, and the reward system, during three light-entrained circadian cycles. A short cycle will be 21hrs, a long cycle 27hrs. During their stay subjects will be fed in energy balance in a food-entrained way, at time-points related to their cycle duration. EEG will be used to measure wake and sleep phases continuously. Appetite and mood profiles will be measured hourly and before and after each meal, by anchored 100mm visual analogue scales and by POMS and STAI-state questionnaires. Also, blood parameters will be measured before and after each meal. Finally, effects on food reward and energy intake will be measured by means of a validated wanting and liking computer test, before and during the evening meal before subjects leave the chamber. This evening meal consists of subjects' food choice, and will be given ad libitum.
- Primary outcomeThe effect of circadian misalignment on:
1. Energy expenditure;
2. Food choice and energy intake.
- Secondary outcomeThe effect of circadian misalignment on:
1. Activity-induced energy expenditure;
2. Substrate oxidation;
3. Sleep quality and sleep time;
4. Mood, feelings of hunger and satiety;
5. The rewarding value of food (wanting and liking);
6. Relevant endocrinological parameters;
7. Body temperature.
- TimepointsSubjects spent 3x21h and 3x27h in the respiration chamber.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Hanne Gonnissen
- CONTACT for SCIENTIFIC QUERIES Hanne Gonnissen
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
University Maastricht (UM)
- PublicationsN/A
- Brief summaryThe prevalence of obesity has increased worldwide to epidemic proportions. Until now, recommendations for improving food intake patterns as well as for normalizing physical activity, have not resulted in solutions for prevention and treatment of obesity. It may be that advices on energy intake and energy expenditure lack the interaction with subjects' individual circadian alignment, or that circadian alignment is disturbed, due to environmental pressure. Therefore, it is important to determine the consequences of circadian misalignment for energy intake and energy expenditure, as well as sleep quality, mood, feelings of hunger and satiety, food choice, and the reward system under controlled energy balance conditions in a respiration chamber.
- Main changes (audit trail)
- RECORD8-jun-2011 - 16-jun-2011


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