Neural, Behavioral and Physiological Correlates of Feeding in Humans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01665560
First received: August 2, 2012
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

The overarching goal of this project is to understand how nicotine addiction interacts with feeding behaviors and brain representation of food reward. The current proposal is part of a larger effort to begin a program of research to elucidate similarities and differences in perception of, and behavioral and neural response to, food and cigarette aromas as a function of 1) smoking status (smokers, ex-smokers who do gain weight, ex-smokers who do not gain weight, non-smokers), 2) internal state (hungry, full), and 3) cigarette deprivation (acute, chronic). A general hypothesis is that there are overlapping neural mechanisms governing food reward and cigarette reward in smokers and that this overlap includes incentive salience encoding.


Condition
Magnetic Resonance Imaging, Functional

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neural, Behavioral and Physiological Correlates of Feeding in Humans

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • fMRI w/ taste and smell stimuli [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]
    Subjects will be scanned on a 3T Trio magnet while tasting and smelling various food and non-food substances. Our primary outcome measure will be differential brain responses to taste and smell stimuli as a function of group (smokers vs. nonsmokers).


Biospecimen Retention:   Samples With DNA

saliva samples were obtained and are stored using a coded ID in a secure part of our facility


Enrollment: 27
Study Start Date: June 2005
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Smokers--Currently Smoking
Individuals that are right handed, and not claustrophobic were recruited. This same group was used for the smoking-group and refrain from smoking was evaluated by CO2 evaluation. To be classified as smokers, they had to report smoking 3-10 cigarettes daily for at least the last year and have a carbon monoxide reading of CO >10 ppm.
Non-Smoker
Healthy individuals meeting the inclusion criteria who claim to not smoke. This is confirmed w/ CO testing.

Detailed Description:

Weight gain frequently follows smoking cessation. Fear of weight gain is cited as a key reason not to quit and actual weight gain is a primary reason for relapse, especially among women. Although the causes of weight gain following smoking cessation are complex, increased caloric intake is recognized as one of the primary sources. One explanation for increased caloric intake is that, there are common neural mechanisms for food and cigarette reward and hence food reward can substitute for cigarette reward and vice versa. An alternative explanation for weight gain following smoking cessation is that there is an overall decrease in brain reward function during nicotine withdrawal, which leads to a decrease in the reward value of food and consequent increase in intake to maintain the total amount of reward obtained by food. The success of the proposed studies relies upon our ability to deliver odorants in the fMRI scanner and to measure neural activation in regions such as the amygdala, which are susceptible to inhomogeneity artifacts.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy adults in the New Haven, CT area.

Criteria

Inclusion Criteria:

  • Healthy
  • between the ages of 18-45
  • fMRI safe

Exclusion Criteria:

  • outside of the above age range
  • not able to have an fMRI (non-removable metal, pacemaker, etc)
  • medical diagnosis related to neurological problems, anxiety, psychiatric conditions
  • Did not refrain from smoking for the described time in the smoking group, or showed a CO2 level consistent with a smoker in the non-smoking group
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665560

Locations
United States, Connecticut
John B Pierce Laboratory
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Dana M Small, PhD Yale & John B Pierce Laboratory
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01665560     History of Changes
Other Study ID Numbers: 0505027690
Study First Received: August 2, 2012
Last Updated: August 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
smoking
fMRI
odors
taste

ClinicalTrials.gov processed this record on July 24, 2014