ObesityNCT00962117
Relationship Between Dopamine Genetics, Food Reinforcement, Energy Intake and Obesity
An observational study of Obesity, run by State University of New York at Buffalo.
Trial summary
The purpose of the study is to determine whether the presentation of various foods produces an increase or decrease in responses on a motivational computer task. In addition, the study determines if energy intake or motivation to obtain food is related to the dopamine receptor genotype. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 310 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Jun 2011
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects will be recruited from newspaper ads, posters on campus and in community settings, web based recruitment (ads on Craig's list and on the department's website) and direct mail targeted to community residents between 18-50 years of age.
Who may be able to join
- Non-smokers
- 18-50 years of age
- No known eating disorder
- Moderate liking for study foods
- No current diagnosis of psychiatric disorder (e.g., anxiety or depression)
- Not on medications that would interfere with appetite (e.g., methylphenidate) or dopaminergic activity
- Non-diabetics
Who cannot join
- Smoker
- Pregnant women
- Current diagnosis of a psychiatric or eating disorder
- Dietary restrictions that would interfere with participation
- On medications that could interfere with appetite or olfactory responsiveness or use of antidepressants or any medication or dietary supplement that could affect appetite or dopaminergic activity
- Excessive use of alcohol (>21 drinks/week), alcoholism,current addiction to opiates, cocaine or stimulants
About this study
Official title: Food Reinforcement Genotype Interactions and Eating
The purpose of the study is to determine whether the presentation of various foods produces an increase or decrease in responses on a motivational computer task. In addition, the study determines if energy intake or motivation to obtain food is related to the dopamine receptor genotype.
Read the detailed description
One of the most important research areas in obesity is developing a better understanding of individual differences in factors that influence excess energy intake and positive energy balance. One key to understanding these individual differences is determining what factors underlie the motivation to eat. We have demonstrated in a series of studies that obese adults and children are more motivated to work for palatable, favorite foods than leaner peers and that those high in food reinforcement consume more food in an ad libitum eating task than those who do not find food as reinforcing. Dopamine (DA) is one of the major neurotransmitters involved in establishing the reinforcing value of food, and low levels of dopamine activity and a reduction in the number of DA receptors is associated with obesity. The general aim of the proposed research is to build upon this research to examine relationships between food reinforcement, obesity, and polymorphisms of genes within the dopaminergic system.
- Conditions
- Obesity
- Keywords
- Food Reinforcement, Energy Intake, Obesity, Dopamine
- 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 |
|---|---|---|
| Obese/Non-obese | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startFeb 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonard Epstein, State University of New York at Buffalo
- Investigators
- Leonard H Epstein, Ph.D., Principal investigator, SUNY Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962117
- Sponsor's protocol ID
- 1066937
- Other IDs
- 1066937-1-44786
- Status last verified
- Jun 2012
- First submitted
- 17 Aug 2009
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lin H, Carr KA, Fletcher KD, Epstein LH. Food reinforcement partially mediates the effect of socioeconomic status on body mass index. Obesity (Silver Spring). 2013 Jul;21(7):1307-12. doi: 10.1002/oby.20158. Epub 2013 Jun 11.
PubMed 23754824Epstein LH, Carr KA, Lin H, Fletcher KD, Roemmich JN. Usual energy intake mediates the relationship between food reinforcement and BMI. Obesity (Silver Spring). 2012 Sep;20(9):1815-9. doi: 10.1038/oby.2012.2. Epub 2012 Jan 13.
PubMed 22245983Epstein LH, Lin H, Carr KA, Fletcher KD. Food reinforcement and obesity. Psychological moderators. Appetite. 2012 Feb;58(1):157-62. doi: 10.1016/j.appet.2011.09.025. Epub 2011 Oct 8.
PubMed 22005184Epstein LH, Carr KA, Lin H, Fletcher KD. Food reinforcement, energy intake, and macronutrient choice. Am J Clin Nutr. 2011 Jul;94(1):12-8. doi: 10.3945/ajcn.110.010314. Epub 2011 May 4.
PubMed 21543545
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Reinforcement Genotype Interactions and Eating
- ClinicalTrials.gov ID
- NCT00962117
- Acronym / sponsor ID
- 1066937
- Conditions
- Obesity
- Keywords
- Food Reinforcement, Energy Intake, Obesity, Dopamine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 19 Aug 2009 (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.
The purpose of the study is to determine whether the presentation of various foods produces an increase or decrease in responses on a motivational computer task. In addition, the study determines if energy intake or motivation to obtain food is related to the dopamine receptor genotype.
Detailed description
One of the most important research areas in obesity is developing a better understanding of individual differences in factors that influence excess energy intake and positive energy balance. One key to understanding these individual differences is determining what factors underlie the motivation to eat. We have demonstrated in a series of studies that obese adults and children are more motivated to work for palatable, favorite foods than leaner peers and that those high in food reinforcement consume more food in an ad libitum eating task than those who do not find food as reinforcing. Dopamine (DA) is one of the major neurotransmitters involved in establishing the reinforcing value of food, and low levels of dopamine activity and a reduction in the number of DA receptors is associated with obesity. The general aim of the proposed research is to build upon this research to examine relationships between food reinforcement, obesity, and polymorphisms of genes within the dopaminergic system.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese/Non-obese | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects will be recruited from newspaper ads, posters on campus and in community settings, web based recruitment (ads on Craig's list and on the department's website) and direct mail targeted to community residents between 18-50 years of age.
Key inclusion criteria (7 listed)
- Non-smokers
- 18-50 years of age
- No known eating disorder
- Moderate liking for study foods
- No current diagnosis of psychiatric disorder (e.g., anxiety or depression)
Key exclusion criteria (6 listed)
- Smoker
- Pregnant women
- Current diagnosis of a psychiatric or eating disorder
- Dietary restrictions that would interfere with participation
- On medications that could interfere with appetite or olfactory responsiveness or use of antidepressants or any medication or dietary supplement that could affect appetite or dopaminergic activity
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
Not reported in the source record.
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 13 Jun 2012.
- Derived from this study: PubMed 23754824Lin H, Carr KA, Fletcher KD, Epstein LH. Food reinforcement partially mediates the effect of socioeconomic status on body mass index. Obesity (Silver Spring). 2013 Jul;21(7):1307-12. doi: 10.1002/oby.20158. Epub 2013 Jun 11.
- Derived from this study: PubMed 22245983Epstein LH, Carr KA, Lin H, Fletcher KD, Roemmich JN. Usual energy intake mediates the relationship between food reinforcement and BMI. Obesity (Silver Spring). 2012 Sep;20(9):1815-9. doi: 10.1038/oby.2012.2. Epub 2012 Jan 13.
- Derived from this study: PubMed 22005184Epstein LH, Lin H, Carr KA, Fletcher KD. Food reinforcement and obesity. Psychological moderators. Appetite. 2012 Feb;58(1):157-62. doi: 10.1016/j.appet.2011.09.025. Epub 2011 Oct 8.
- Derived from this study: PubMed 21543545Epstein LH, Carr KA, Lin H, Fletcher KD. Food reinforcement, energy intake, and macronutrient choice. Am J Clin Nutr. 2011 Jul;94(1):12-8. doi: 10.3945/ajcn.110.010314. Epub 2011 May 4.
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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.
Leonard H Epstein, Ph.D. principal investigator
SUNY Buffalo
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by State University of New York at Buffalo.
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 7 inclusion and 6 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 13 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00962117, which also lists 4 linked publications.
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 13 Jun 2012.