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Effects of timing of food intake on glucose metabolism and the brain during a hypocaloric diet in obese subjects


- candidate number22423
- NTR NumberNTR5399
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-jul-2015
- Secondary IDs2014_200 METC
- Public TitleEffects of timing of food intake on glucose metabolism and the brain during a hypocaloric diet in obese subjects
- Scientific TitleEffects of timing of food intake on glucose metabolism and the brain during a hypocaloric diet in obese subjects
- ACRONYMTIME
- hypothesisConsuming most calories at breakfast compared to at dinner leads to more suppression of appetite and craving and enhances insulin sensitivity.
- Healt Condition(s) or Problem(s) studiedObesity, Diabetes Mellitus Type 2 (DM type II)
- Inclusion criteriamen
>50 y
BMI >30
fasting glucose > 5.6 and/or insulin > 74
Stable weight three months prior to study inclusion
- Exclusion criteriaUse of any medication except for those related to treatment of components of the metabolic syndrome (excluding insulin, oral glucose lowering drugs, beta-blockers)
Any actual medical condition except for treated hypothyroidism and the metabolic syndrome
History of any psychiatric disorder
Shift work
Irregular sleep pattern
Intensive sports (>3/week)
Restrained eaters
History of eating disorders (anorexia, binge eating, bulimia)
Smoking, XTC, amphetamine or cocaine abuse
Alcohol abuse (>3/day)
Contraindication MRI
Lactose intolerance
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2014
- planned closingdate1-mrt-2015
- Target number of participants25
- InterventionsSubjects will reduce their daily caloric intake with 50% for 4 weeks. Subjects will be randomized into either a hypocaloric diet group where 15% of total kcal have to be consumed with breakfast, 35% kcal with lunch and 50% kcal with dinner or a hypocaloric diet group where 50% of kcal have to be consumed with breakfast, 35% kcal with lunch and 15% kcal with dinner.
- Primary outcome1. Insulin sensitivity (hyperinsulinemic euglycemic clamp)
2. Diencephalic SERT ( [123I]FP-CIT SPECT)
3. Brain 5-HT neurotransmission (pharmacological MRI (phMRI) using citalopram).
- Secondary outcomeMotivation and impulse control
Abdominal and liver fat
Circulating hormones and substrates: blood drawing
Sleep duration
Resting energy expenditure
Sympathetic and parasympathetic activity
Feeding behaviour
- Timepointsbefore and after diet
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Ruth Versteeg
- CONTACT for SCIENTIFIC QUERIES Ruth Versteeg
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
STW/NWO
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD7-jul-2015 - 18-okt-2015


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