Plain English Summary
Background and study aims
Hedonic hyperphagia (overeating for pleasure) is a major cause of obesity. Specific foods such as snack food may cause someone to eat even when they are full. This study looks at how snack foods induce food intake using Magnetic Resonance Imaging (MRI) scans of the brain.
Who can participate?
Men aged between 25-50 years with a body mass index (BMI) of no more than 27kg/m2
What does the study involve?
All participants attend two sessions of brain MRI scans of about 40 minutes in total to see how different foods can affect the brain. These studies are completed within one week. The participants are asked to not eat for at least two hours before the experiment. Participants are scanned after viewing images of potato chips and zucchini. There is then a break of 5 minutes where the participants leave the scanner and are asked to eat either potato chips or sliced zucchini for 2 minutes, followed by another scan.
What are the possible benefits and risks of participating?
The benefit will be to contribute to the research of how diet can influence the brain. This study does not involve any major risks.
Where is the study run from?
Friedrich-Alexander-Universität Erlangen-Nürnberg (Germany)
When is the study starting and how long is it expected to run for?
December 2015 to August 2017
Who is funding the study?
Friedrich-Alexander-Universität Erlangen-Nürnberg (Germany)
Who is the main contact?
Prof. Dr. Andreas Hess
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Faunt1
Study information
Scientific title
High vs low caloric food modulation of human resting-state functional connectivity in healthy individuals
Acronym
Study hypothesis
Resting state networks (RSNs) can individually adapt to experience after short time exposures to a stimulus, and these RSNs are a good indicator for addictive behaviors. The current study hypothesizes that visualization and ingestion of different food types (high-caloric: chips, and low-caloric: zucchini) will elicit distinct changes in the RSNs of healthy individuals.
Ethics approval
Ethik-Kommission der Medizinischen Fakultät of Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), 15/09/2015, ref: 220_15B
Study design
Single-center single-blind controlled trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Nutrition
Intervention
Every subject will undergo two different fMRI sessions of ~40 minutes in total. The interval between the two sessions was 3 days. Participants will arrive to the fMRI unit previously knowing what food they will be presented each day.
The subjects will be asked not to eat food for at least two hours before the experiment.
In each session resting state will be measured twice. Each fMRI session will start by acquiring the individual anatomical imaging, followed by the first resting state RS scan, BOLD visual stimulation (presentation of different images of potato chips and zucchini) image presentation: total 196 vol. (time points) = 28 x 7 , 1 block of images contain 7 images, 1 image = 1 vol. = 3 sec). There will then be a pause of 5 minutes, where the participants will exit the scanner and be asked to consume day 1= salted potato chips 528kcal/100g 33% fats 49% carbohydrates, day 3= sliced zucchini 17kcal/100g 3% fats 3.5% carbohydrates ad libitum for 2 minutes, followed by the second resting state RS scan.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Brain activity measured using fMRI after the visual stimulation and consumption of the different foods
Secondary outcome measures
Correlation of BMI with changes in brain activation measured using fMRI after the visual stimulation and consumption of the different foods
Overall trial start date
15/12/2015
Overall trial end date
01/08/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy
2. Right handed
3. BMI from 19 to 27
4. Aged 25-50
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
15
Participant exclusion criteria
1. Any current or past form neurological/psychiatric diseases
2. BMI outside the range of 19-27
3. Any contradictions to fMRI scanning
Recruitment start date
15/12/2015
Recruitment end date
15/12/2016
Locations
Countries of recruitment
Germany
Trial participating centre
Universitätsklinikum Erlangen
Erlangen
91054
Germany
Trial participating centre
Friedrich-Alexander-Universität Erlangen-Nürnberg
Erlangen
91054
Germany
Funders
Funder type
University/education
Funder name
Friedrich-Alexander-Universität Erlangen-Nürnberg
Alternative name(s)
Friedrich Alexander University of Erlangen Nuremberg, FAU
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Germany
Results and Publications
Publication and dissemination plan
Study protocol, statistical analysis plan among other additional information will be available upon request. Planned publication in a high-impact peer reviewed journal in August 2018.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Dr. Andreas Hess. Type of data: resting state fMRI. Data availability: August 2017-unlimited. Access criteria: research purposes. Consent from participants was obtained, anonymisation was carried out by a third person not belonging to the study.
Intention to publish date
01/08/2018
Participant level data
Available on request
Basic results (scientific)
Publication list