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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02041039
Other study ID # R01DK089070
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2010
Est. completion date October 2024

Study information

Verified date April 2023
Source Indiana University
Contact Robert V Considine, Ph.D.
Phone 317-278-0373
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Food aromas are a part of foods' flavor, and can promote overeating. Alcohol consumption also stimulates appetite, and contributes to overeating while under alcohol's acute effects. Knowing the brain regions that respond to food aromas and alcohol, and how they are modified by the amount of body fat and alcohol exposure, will provide critical information about the neural systems that underlie loss of control of eating. Therefore, the main hypotheses of this study are that: A) Lean and obese subjects have different brain responses to food aromas that enhance desire to eat, and B) Acute alcohol intoxication i) enhances the brain's response to food odors, and ii) affects brain systems that inhibit or terminate eating. To test these hypotheses, we have modified functional magnetic resonance imaging (fMRI) paradigms successfully used to study alcoholic drink aromas in subjects at risk for alcoholism.


Description:

Food aromas are powerful appetitive cues that are intrinsic to foods' flavor and hedonic qualities, and such cues can facilitate overeating. Alcohol consumption similarly "primes" appetite, and contributes to overeating while under alcohol's acute effects. Knowing the brain loci that respond to such naturalistic appetitive stimuli, and how they are modified by body fat and alcohol exposure, will provide critical insights about the neural systems that underlie loss of control of eating. Therefore, the main hypotheses of this study are that: A) Lean and obese subjects have different limbic responses to the olfactory cues that enhance motivation to eat, and B) Acute alcohol intoxication i) potentiates the brain's reward system response to food odors, and ii) affects brain systems involved in behavioral inhibition and eating restraint. To test these hypotheses, we have modified functional magnetic resonance imaging (fMRI) paradigms successfully used to study alcoholic drink aromas in subjects at risk for alcoholism.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - non smoking, right handed women 18-40 years - good health without self reported neurological or psychiatric disorder - no indication of eating disorders - normal sense of smell Exclusion Criteria: - pregnant,/breast feeding women - history of drug abuse/dependence, positive drug screen for amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates or PCP - DSM-IV axis I psychiatric disorders or head injury with loss of consciousness - contraindications to MRI (ferrous material, claustrophobia)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Indiana University School of Medicine Indianapolis Indiana

Sponsors (2)

Lead Sponsor Collaborator
Robert Considine National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary neural response to food odor 1 month
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