Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/08/2017
Date assigned
17/08/2017
Last edited
06/09/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Andreas Hess

ORCID ID

Contact details

Fahrstraße 17
22
Erlangen
91054
Germany

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

01/08/2019

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

Sponsor information

Organisation

Friedrich-Alexander-Universität Erlangen-Nürnberg

Sponsor details

c/o Dr. rer. nat. Esther Schnetz
Schlossplatz 4
Erlangen
91054
Germany

Sponsor type

University/education

Website

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.

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. 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

01/08/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/09/2018: The overall trial end date was changed from 01/08/2017 to 01/08/2019.