Snack food influence on resting state activity in healthy individuals
| ISRCTN | ISRCTN11231856 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11231856 |
| Secondary identifying numbers | Faunt1 |
- Submission date
- 16/08/2017
- Registration date
- 17/08/2017
- Last edited
- 06/09/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Fahrstraße 17, 22
Erlangen
91054
Germany
Study information
| Study design | Single-center single-blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | High vs low caloric food modulation of human resting-state functional connectivity in healthy individuals |
| Study objectives | 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(s) | Ethik-Kommission der Medizinischen Fakultät of Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), 15/09/2015, ref: 220_15B |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 15/12/2015 |
| Completion date | 01/08/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 15 |
| Key inclusion criteria | 1. Healthy 2. Right handed 3. BMI from 19 to 27 4. Aged 25-50 |
| Key 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 |
| Date of first enrolment | 15/12/2015 |
| Date of final enrolment | 15/12/2016 |
Locations
Countries of recruitment
- Germany
Study participating centres
91054
Germany
91054
Germany
Sponsor information
University/education
c/o Dr. rer. nat. Esther Schnetz
Schlossplatz 4
Erlangen
91054
Germany
"ROR" |
https://ror.org/00f7hpc57 |
|---|
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- FAU Erlangen-Nürnberg, University of Erlangen-Nuremberg, Friedrich Alexander University of Erlangen Nuremberg, FAU
- Location
- Germany
Results and Publications
| Intention to publish date | 01/08/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| IPD sharing plan | 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. Access criteria: research purposes. Consent from participants was obtained, anonymisation was carried out by a third person not belonging to the study. |
Editorial Notes
06/09/2018: The overall trial end date was changed from 01/08/2017 to 01/08/2019.
