AdiposityNCT01906411
Dopaminergic Function and Food Reward
An observational study of Adiposity and Weight Loss, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The broad aim of the study is to obtain a better understanding of alterations in mesolimbic reward pathways in adiposity based on the hypothesis of a hypofunctioning reward system in obesity. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adiposity, Weight Loss
- What is being tested?
- Dopamine depletion vs. Balanced aminoacid drink
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento Mar 2014
- 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 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: community sample
Who may be able to join
- female
- healthy
Who cannot join
- fMRI contraindications
- claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
The broad aim of the study is to obtain a better understanding of alterations in mesolimbic reward pathways in adiposity based on the hypothesis of a hypofunctioning reward system in obesity.
This will be achieved by integrating a functional neuroimaging (fMRI) with behavioral reward tasks and the modulation of the dopamine level by dopamine depletion.
- Conditions
- Adiposity, Weight Loss
- Being tested
- Dopamine depletion vs. Balanced aminoacid drink
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dopamine depletion vs. Balanced aminoacid drinkDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| subjecst with different BMI | Not described Receives: Dietary Supplement: Dopamine depletion vs. Balanced aminoacid drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential brain functions in the dopaminergic reward system
differential brain fuctions will be measured by blood oxygen level dependent effect.
Measured: 4 hours after intake of the dopamine depletion or balanced aminoacid drink
Secondary outcomes (1)
amino acid level changes due to dopamine depletion
Measured: 4 hours after intake of the dopamine depletion or balanced aminoacid drink
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Primary completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabine Frank, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906411
- Sponsor's protocol ID
- DAD
- Status last verified
- May 2015
- First submitted
- 8 Jul 2013
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopaminergic Function and Food Reward
- ClinicalTrials.gov ID
- NCT01906411
- Acronym / sponsor ID
- DAD
- Conditions
- Adiposity, Weight Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Primary completion
- Mar 2014 (actual)
- First posted
- 24 Jul 2013 (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 broad aim of the study is to obtain a better understanding of alterations in mesolimbic reward pathways in adiposity based on the hypothesis of a hypofunctioning reward system in obesity.
This will be achieved by integrating a functional neuroimaging (fMRI) with behavioral reward tasks and the modulation of the dopamine level by dopamine depletion.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjecst with different BMI | – | Dietary Supplement: Dopamine depletion vs. Balanced aminoacid drink |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- community sample
Key inclusion criteria (2 listed)
- female
- healthy
Key exclusion criteria (2 listed)
- fMRI contraindications
- claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dopamine depletion vs. Balanced aminoacid drink | Dietary supplement | subjecst with different BMI |
Primary outcome
Differential brain functions in the dopaminergic reward system
Time frame: 4 hours after intake of the dopamine depletion or balanced aminoacid drink
differential brain fuctions will be measured by blood oxygen level dependent effect.
1 secondary outcome
amino acid level changes due to dopamine depletion
Time frame: 4 hours after intake of the dopamine depletion or balanced aminoacid drink
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 29 May 2015.
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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 and Weight Loss, run by University Hospital Tuebingen at 1 site in Germany.
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 2 inclusion and 2 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 29 May 2015. 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 Germany. 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?
Differential brain functions in the dopaminergic reward system (time frame: 4 hours after intake of the dopamine depletion or balanced aminoacid drink). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2015.