NCT02298049

Brief Summary

To our knowledge no study has assessed the effects of a meal on neural responses to food cues and compared this with a condition simulating natural inter-meal hunger levels. This is important, as the existing literature often compares the effect of fasting to satiation, which may not reflect typical appetite processes. Thus, the purpose of this research was to examine the effect of a satiating lunch compared to a normal pre-meal state on blood oxygen level dependent (BOLD) activity in the human brain, as measured using functional magnetic resonance imaging (fMRI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

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, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
Last Updated

November 21, 2014

Status Verified

November 1, 2014

Enrollment Period

5 months

First QC Date

November 19, 2014

Last Update Submit

November 20, 2014

Conditions

Keywords

fMRIrewardsatiation

Outcome Measures

Primary Outcomes (1)

  • Activation differences between satiated and pre-meal scan fMRI BOLD signal

    6 months

Study Arms (1)

Scanning

OTHER

Repeated measures: Satiation scan + Pre-meal scan All participants undertook both scans

Other: Satiated / Pre-mealDevice: MRI

Interventions

All participants were scanned before and after not being fed (pre-meal), and before and after being given a satiating lunch (satiated).

Scanning
MRIDEVICE
Scanning

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers
  • Sufficiently fluent in English to understand the task and the instructions

You may not qualify if:

  • Currently taking medication
  • Past or current depression/dieting,
  • Smokers
  • Food allergies
  • Diabetes
  • Pregnancy
  • BMI score outside the normal range
  • Any contraindications to fMRI scanning (e.g. pacemakers, mechanical heart valve, hip replacement, metal implants)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Birmingham

Birmingham, West Midlands, B15 2TT, United Kingdom

Location

Related Publications (1)

  • Thomas JM, Higgs S, Dourish CT, Hansen PC, Harmer CJ, McCabe C. Satiation attenuates BOLD activity in brain regions involved in reward and increases activity in dorsolateral prefrontal cortex: an fMRI study in healthy volunteers. Am J Clin Nutr. 2015 Apr;101(4):697-704. doi: 10.3945/ajcn.114.097543. Epub 2015 Jan 21.

Study Officials

  • Jason M Thomas, MRes

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2014

First Posted

November 21, 2014

Study Start

July 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

November 21, 2014

Record last verified: 2014-11

Locations