NCT03472703

Brief Summary

To get a better understanding of the interaction between metabolism, neural responses, cognitive processes and appetite the investigaters will examine the effect of food consumption on cognitive processes. The investigaters will look at the effect of satiation on cognitive performance on both a behavioural and neuronal level. In this study participants will undergo functional magnetic resonance imaging (fMRI) measurements while performing a food reward and inhibition task, and in addition perform a memory, working memory and delay discount task, once when hungry and once when full.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

July 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2018

Completed
Last Updated

May 3, 2018

Status Verified

March 1, 2018

Enrollment Period

9 months

First QC Date

January 17, 2018

Last Update Submit

May 2, 2018

Conditions

Eating BehaviorHungerInhibitionFunctional Magnetic Resonance Imaging

Keywords

fMRICognitive processesInhibitionFood rewardAppetite

Outcome Measures

Primary Outcomes (3)

  • fMRI brain responses during inhibition

    \- Neural activation correct No-Go vs. Go trail. Subjects neural activation when they are instructed to go (press) when seeing toiletry or stationary items and react correctly compared to when subjects are instructed not to go (no press) when seeing a food or sport and withhold correctly

    14 minutes

  • fMRI brain repsonse during inhibition to a food stimuli

    Neural activation during correct inhibition food vs. non-food stimuli trail. Comparing the brain response when subjects correctly withhold for food vs a sports item.

    14 minutes

  • fMRI neural network during inhibition to a food stimuli

    Functional connectivity during correct inhibition food vs. non-food stimuli trail.

    14 minutes

Secondary Outcomes (5)

  • Word recall

    10 minutes

  • Delay discount of food reward

    10 minutes

  • Delay discount of money reward

    10 minutes

  • Reaction time to target

    25 minutes

  • fMRI brain activity in food picture task

    18 minutes

Study Arms (2)

Hungry

OTHER

Her subjects will first have a break, then undergo all measurement and at the end of the study-day they will receive their lunch

Other: Break-Lunch time

Satiated

OTHER

Her subjects will first receive their lunch, then perform all the tasks and last will have a break

Other: Break-Lunch time

Interventions

Break-Lunch timeOTHER

The time for the break and lunch will be contrary, depending on their visit/session

HungrySatiated

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects
  • Age 18-45 years at start of the study
  • Right-handedness (including left-handers could bias the results because of the laterality of brain functions)
  • Ability to give informed consent
  • Fluent English speaking
  • Willingness to be informed about chance findings of pathology

You may not qualify if:

  • Subjects who have a non-removable metal object in or at their body, such as, for example: Heart pace-maker, artificial heart valve, metal prosthesis, implants or splinters, non-removable dental braces
  • Tattoos, that are older than 15 years
  • Claustrophobia
  • Pathological hearing ability or an increased sensitivity to loud noises
  • Lack of ability to give informed consent
  • Operation less than three months ago
  • Acute illness or infection during the last 4 weeks
  • Cardiovascular disorders (e.g., hypertrophic cardiomyopathy, long QT syndrome)
  • Moderate or severe head injury
  • Eating disorders
  • No metabolic (e.g. metabolic disorder, diabetes, insulin resistance), psychological (e.g. depression) or neurological (e.g. epilepsy, headache disorder, multiple sclerosis, traumatic brain injuries) diseases or medication in relation to these diseases.
  • Current weight loss regimens, or more then 5kg weight loss in the last 3 months
  • Smoking
  • Current pregnancy or breastfeeding
  • Current or past history of drug or alcohol dependency - alcohol consumption exceeding 12 units a week
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Birmingham School of Psychology

Birmingham, Midlands, B15 2TT, United Kingdom

Location

MeSH Terms

Conditions

Feeding BehaviorInhibition, Psychological

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Maartje S Spetter, PhD

    UoB

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: We will use a counter-balanced, crossover, within-subject design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2018

First Posted

March 21, 2018

Study Start

July 1, 2017

Primary Completion

April 10, 2018

Study Completion

April 10, 2018

Last Updated

May 3, 2018

Record last verified: 2018-03

Locations

GB(1)