Fat Perception in the BrainNCT02213406
Neuronal and Sensory Perception of Fat
A study testing yogurt in people with Fat Perception in the Brain, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
This project will examine neuronal and sensory fat perception. Our hypothesis is that subjects being either hypersensitive or hyposensitive for fat will show different brain activities. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fat Perception in the Brain
- What is being tested?
- yogurt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Start not givento Jul 2017
- Phase
- Interventional
- 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
Who may be able to join
- healthy
Who cannot join
- lactose intolerance
- fMRI contraindications (metal implants,...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fat and the Brain-Neuronal and Sensory Fat Perception
This project will examine neuronal and sensory fat perception. Our hypothesis is that subjects being either hypersensitive or hyposensitive for fat will show different brain activities. Therefore the investigators will conduct functional magnetic resonance imaging (fMRI) and fat detection threshold tests examining neuronal and sensory fat perception.
- Conditions
- Fat Perception in the Brain
- Being tested
- yogurt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yogurtDietary supplement
Subjects will receive yogurt with varying fat concentrations
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Fat detection threshold test, intake of high and low fat yogurt, fMRI-measurements Receives: Dietary Supplement: yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat detection thresholds
A sensory test will be conducted to establish individual fat detection thresholds. It is expected that subjects* brain activity is dependent on sensory fat sensitivity.
Measured: each measurement day
Secondary outcomes (1)
Brain activity
We are interested in brain activations following the consumption of yogurt with either a high or a low fat concentration. To assess this, before as well as after fat intake brain activity will be measured using functional magnetic resonance imaging (fMRI). We expect that brain activity will differ between the high and the low fat yogurt condition.
Measured: pre and post meal intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fat Perception in the BrainStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
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
- NCT02213406
- Sponsor's protocol ID
- NSFP
- Status last verified
- Jul 2017
- First submitted
- 5 Aug 2014
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fat and the Brain-Neuronal and Sensory Fat Perception
- ClinicalTrials.gov ID
- NCT02213406
- Acronym / sponsor ID
- NSFP
- Conditions
- Fat Perception in the Brain
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 11 Aug 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.
This project will examine neuronal and sensory fat perception. Our hypothesis is that subjects being either hypersensitive or hyposensitive for fat will show different brain activities. Therefore the investigators will conduct functional magnetic resonance imaging (fMRI) and fat detection threshold tests examining neuronal and sensory fat perception.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Dietary Supplement: yogurtFat detection threshold test, intake of high and low fat yogurt, fMRI-measurements |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy
Key exclusion criteria (2 listed)
- lactose intolerance
- fMRI contraindications (metal implants,...)
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 |
|---|---|---|
| yogurtSubjects will receive yogurt with varying fat concentrations | Dietary supplement | intervention group |
Primary outcome
Fat detection thresholds
Time frame: each measurement day
A sensory test will be conducted to establish individual fat detection thresholds. It is expected that subjects* brain activity is dependent on sensory fat sensitivity.
1 secondary outcome
Brain activity
Time frame: pre and post meal intake
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 6 Jul 2017.
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?
A study testing yogurt in people with Fat Perception in the Brain, 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 1 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 6 Jul 2017. 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?
Fat detection thresholds (time frame: each measurement day). 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 6 Jul 2017.