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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02298049
Other study ID # UBirmingham
Secondary ID
Status Completed
Phase N/A
First received November 19, 2014
Last updated November 20, 2014
Start date July 2010
Est. completion date December 2010

Study information

Verified date November 2014
Source University of Birmingham
Contact n/a
Is FDA regulated No
Health authority National Research Ethics Service United Kingdom':'
Study type Interventional

Clinical Trial 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).


Description:

We hypothesized that satiation would be associated with decreased brain activity across brain regions involved in both appetite and reward such as ventromedial prefrontal cortex, orbitofrontal cortex, ventral striatum, hypothalamus, insula, amygdala and hippocampus. 16 healthy participants (8 males) were scanned on two separate test days, before and after eating a meal to satiation, or after not eating for 4 hours (satiated vs. pre-meal). fMRI BOLD signals to the sight and/or taste of the stimuli were recorded. Participants were given questionnaires to complete about their mood state and appetite before and after all scans.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Healthy volunteers

- Sufficiently fluent in English to understand the task and the instructions

Exclusion Criteria:

- 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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Satiated / Pre-meal
All participants were scanned before and after not being fed (pre-meal), and before and after being given a satiating lunch (satiated).
Device:
MRI


Locations

Country Name City State
United Kingdom University of Birmingham Birmingham West Midlands

Sponsors (2)

Lead Sponsor Collaborator
University of Birmingham University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Activation differences between satiated and pre-meal scan fMRI BOLD signal 6 months No
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