NCT03081585

Brief Summary

The aim of this study is to investigate the influence of different metabolic states and hormonal satiety signalling on responses in neural reward networks.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2017

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

March 10, 2017

Last Update Submit

March 28, 2022

Conditions

Keywords

fmrineuronal reward processinghormonal satiety signallingfasting

Outcome Measures

Primary Outcomes (2)

  • Experimental fMRI task (incentive delay task)

    Participants were expecting food and monetary related reward, after a correct response to a simple task they received either food or monetary related reward.

    22 min.

  • Resting state brain activity using functional magnetic resonance imaging

    Functional brain imaging will be employed to assess functional connectivity in reward related brain networks.

    5 min.

Secondary Outcomes (2)

  • Analysis of hormonal satiety signaling

    30 min. before scanning

  • Self-report questionnaire regarding eating behavior (Dutch Eating Behavior Questionnaire)

    30 min.

Study Arms (1)

Healthy Controls

Normal weight, healthy female participants

Behavioral: Satiety State

Interventions

Satiety StateBEHAVIORAL

Participants were scanned twice: once after a meal and once after fasting for 24 hours

Healthy Controls

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy normal weight female participants

You may qualify if:

  • BMI \<25 kg/m² and \>18.5 kg/m²
  • no lifetime or current medical illness that could potentially affect appetite or body weight
  • right-handedness
  • normal or corrected-to-normal vision

You may not qualify if:

  • history of head injury or surgery
  • history of neurological disorder
  • severe psychiatric disorder (psychosis, bipolar disorder, substance abuse)
  • smoking
  • borderline personality disorder
  • current psychotropic medication
  • inability to undergo fMRI scanning (e.g. metallic implants, claustrophobia, Pacemakers)
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Simon JJ, Wetzel A, Sinno MH, Skunde M, Bendszus M, Preissl H, Enck P, Herzog W, Friederich HC. Integration of homeostatic signaling and food reward processing in the human brain. JCI Insight. 2017 Aug 3;2(15):e92970. doi: 10.1172/jci.insight.92970. eCollection 2017 Aug 3.

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Joe Simon, Dr. Dipl. Psych.

    University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2017

First Posted

March 16, 2017

Study Start

June 9, 2015

Primary Completion

June 10, 2016

Study Completion

June 10, 2016

Last Updated

March 29, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share