AdiposityNCT02041039
Reward System Responses to Food Aromas
An observational study of Adiposity, run by Robert Considine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adiposity
- How many people
- 332 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2011to 11 Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: subjects to be drawn from the Indianapolis and greater metropolitan area
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
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.
Read the detailed 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.
- Conditions
- Adiposity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
neural response to food odor
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study start15 Apr 2011
- Primary completion11 Sep 2015
- Study completion11 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdiposityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Considine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert Considine, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041039
- Sponsor's protocol ID
- R01DK089070
- Status last verified
- Jul 2024
- First submitted
- 17 Jan 2014
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24695888
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reward System Responses to Food Aromas
- ClinicalTrials.gov ID
- NCT02041039
- Acronym / sponsor ID
- R01DK089070
- Conditions
- Adiposity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Robert ConsidineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Apr 2011 (actual)
- Primary completion
- 11 Sep 2015 (actual)
- Study completion
- 11 Sep 2015 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- subjects to be drawn from the Indianapolis and greater metropolitan area
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
neural response to food odor
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Derived from this study: PubMed 24695888Eiler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adiposity, run by Robert Considine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neural response to food odor (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02041039, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.