NCT02041039

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
332

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Longer than P75 for all trials

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

April 15, 2011

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2015

Completed
Last Updated

July 11, 2024

Status Verified

July 1, 2024

Enrollment Period

4.4 years

First QC Date

January 17, 2014

Last Update Submit

July 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • neural response to food odor

    1 month

Study Arms (2)

normal weight

non-smoking, right handed women age 18-40 years BMI between 18-25 kg/m2

overweight/obese

non-smoking, right-handed women age 18-40 year BMI 30-50 kg/m2 (maximum weight 350 pounds, shoulder width no greater than 23/5 inches)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

subjects to be drawn from the Indianapolis and greater metropolitan area

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • Eiler WJ 2nd, Dzemidzic M, Case KR, Armstrong CL, Mattes RD, Cyders MA, Considine RV, Kareken DA. Ventral frontal satiation-mediated responses to food aromas in obese and normal-weight women. Am J Clin Nutr. 2014 Jun;99(6):1309-18. doi: 10.3945/ajcn.113.080788. Epub 2014 Apr 2.

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum/plasma

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 17, 2014

First Posted

January 20, 2014

Study Start

April 15, 2011

Primary Completion

September 11, 2015

Study Completion

September 11, 2015

Last Updated

July 11, 2024

Record last verified: 2024-07

Locations