|- candidate number||28210|
|- NTR Number||NTR6832|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-nov-2017|
|- Secondary IDs||17/374 NL 61259.041.17|
|- Public Title||De hersenreacties tijdens het leren van aangename ervaringen met voedselstimuli en voedselkeuze in gezonde proefpersonen met een normaal gewicht of obesitas (NEUROFOOD)|
|- Scientific Title||NEURal correlates Of FOOD cue reward learning and food choice in obese and normal weight volunteers (NEUROFOOD)|
|- hypothesis||1. Obese individuals have increased acquisition and decreased extinction compared with normal-weights. |
2. Obese individuals have less inhibitory control than normal weight adults, and are therefore expected to show less activation in areas related to inhibition (dlPFC, IFG). Furthermore, we expect that vmPFC activation will reflects both taste and health considerations in normal weight individuals, but only reflects taste in obese subjects.
|- Healt Condition(s) or Problem(s) studied||Obesity|
|- Inclusion criteria|| Healthy (self-reported)|
Between 18 and 45 years old.
Having given their written informed consent
|- Exclusion criteria|| Having a food allergy for any of the foods used as stimuli (i.e., ingredients of the milkshake and depicted on the food pictures)|
Having a history of or current alcohol consumption > 28 units per week
Having a history of medical or surgical events that may significantly affect the study
outcome, such as metabolic or endocrine disease, or any gastro-intestinal disorder
Mental or physical status that is incompatible with the proper conduct of the study
Not having a general practitioner
Participation in any other clinical trial during this study.
MRI exclusion criteria, including
o Presence of metal in body incompatible with MRI scanning
o Being pregnant.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||26-nov-2017|
|- planned closingdate||1-mrt-2019|
|- Target number of participants||90|
|- Primary outcome||1. Neural activation (percentage signal change) in response to acquisition and extinction of cue-reward associations.|
2. Neural activation (percentage signal change) in response to (un)healthy food choice.
|- Secondary outcome||3. Scores on the liking of the food images and their perceived healthiness|
4. Body weight at follow up.
5. Perceived temptation strength of the environment (ecological momentary assessment)
6. Cue reactivity
|- Timepoints||Body weight at follow up will be measured at 3 and at 6 months after the study day.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr. P.A.M. Smeets|
|- CONTACT for SCIENTIFIC QUERIES||Dr. P.A.M. Smeets|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|European Union Seventh Framework Programme (FP7/2007-2013) Grant Agreement 607310 (Nudge-It)|
|- Brief summary||The current food environment is abundant of food-related cues which trigger behaviours that facilitate consumption. Also, the decision to choose a healthy or unhealthy food is important in the regulation of food intake and therefore in weight management. As the burden of overweight is increasing in the Netherlands as well as worldwide, it is important to get more insight into the mechanisms of how food cues acquire their rewarding and motivating properties and those that underlie healthy food choice. The primary objectives of this study are to investigate whether the neural responses during acquisition and extinction of cue-reward associations differ between obese and normal weight individuals; and to investigate whether the neural correlates of self-control in the food domain differ between obese and normal weight individuals. The secondary objective of this study is to investigate whether the neural responses during acquisition and extinction of cue-reward associations relates to weight change at 3 and 6 months of follow up. This study is an observational study. Participants are followed up for 6 months. The study starts with a study session in which neural responses to food choice, reward learning are measured, as well as cue-reactivity and weight. In the week subsequent to the study session, perceived temptation strength of the environment is measured and weight is measured at 3 and 6 months follow up. 90 Healthy human volunteers will be included, 30 volunteers with a body mass index 18.5 25.0 kg/m2 and 60 volunteers with a body mass index ≥ 30.0 kg/m2, equal numbers of male and female participants.|
|- Main changes (audit trail)|
|- RECORD||20-nov-2017 - 7-dec-2017|