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van CCT (UK)

van CCT (UK)

Effects of FASTING the brain

- candidate number27572
- NTR NumberNTR6609
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-jul-2017
- Secondary IDsMETC2016_315 METC AMC
- Public TitleEffects of FASTING the brain
- Scientific TitleEffects of FASTING duration on cerebral serotonin and dopamine transporter availability in lean and obese subjects
- hypothesisWe hypothesize that 1) fasting duration may affect the central serotonin and dopamine systems, either centrally or indirectly through effects on peripheral input to the central nervous system, and 2) the effect of fasting may be changed in obesity.
- Healt Condition(s) or Problem(s) studiedObesity, Fasting, Dopamine system, Serotonergic system
- Inclusion criteria- Male
- BMI<25kg/m2 (lean subjects) or BMI 30kg/m2 (obese subjects)
- Age 50-75 years
- Stable weight three months prior to study inclusion
- Exclusion criteria- Use of any medication except for those related to treatment of components of the metabolic syndrome
- Use of exogenous 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 h/week)
- Restrained eaters
- History of eating disorders (anorexia, binge eating, bulimia)
- Smoking, XTC, amphetamine or cocaine abuse
- Alcohol abuse (>3 units/day)
- Lactose intolerance
- Estimated glomerular filtration rate <60 ml/min
- Contraindication to MRI scanning (claustrophobia, metal foreign objects)
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 13-mrt-2017
- planned closingdate30-sep-2017
- Target number of participants20
- InterventionsFasting intervention: participants will undergo [123I]FP-CIT SPECT scans on two study days, prior to one study day participants will fast for 12 hours, prior to the other study day participants will fast for 24 hours.
Diet intervention: prior to each fasting intervention, participants will consume an eucaloric diet for 72 hours. Eucaloric enery requirements are based on resting energy expenditure measured with indirect calorimetry.
- Primary outcomeSerotonin and dopamine transporter availability: [123I]FP-CIT SPECT scan
- Secondary outcome- Circulating hormones and substrates: venous blood drawing
- REE: indirect calorimetry
- Feeding behavior: validated questionnaires
- Timepoints2 SPECT scan study days: one preceded by 12 hours of fasting, the other by 24 hours of fasting
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Amsterdam
- Publications
- Brief summaryRationale: Feeding behaviour is regulated by a complex interplay of the homeostatic and hedonic systems, and is influenced by peripheral inputs. The neurotransmitters serotonin and dopamine have major roles in the cerebral regulation of feeding behaviour by mediating anorexigenic and rewarding signals, respectively. Extracellular levels of serotonin and dopamine are regulated by serotonin and dopamine transporters (SERT and DAT) respectively and they can be visualized using SPECT.
In obesity, control of food intake is disturbed, resulting in overconsumption of high-calorie nutrients. Therefore, the role of the central nervous system, and serotonin and dopamine in particular, in the current obesity epidemic is an active interest of ongoing research worldwide. Fasting influences neural signals and hormones that provide input to the central regulation of food intake. Studying the effects of fasting on brain areas involved in overeating/obesity, as well as differences in the response to fasting between lean and obese individuals, may unravel novel therapeutic targets for (the prevention of) obesity. In addition, since it is currently unknown how fasting affects central SERT and DAT, interpretation of previous studies that investigate effects of lifestyle, diet and/or metabolic challenges on cerebral serotonin and dopamine in humans is troublesome because these studies vary in fasting duration prior to the measurement of cerebral SERT and DAT availability.
- Main changes (audit trail)
- RECORD20-jul-2017 - 13-aug-2017

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