Fat Processing in the BrainNCT01516021
How Fat Influences the Brain
A study testing intake of high or low fat yoghurt in people with Fat Processing in the Brain, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The aim of the current study was to investigate the effect of a high versus a low fat meal (operationalized by high and low fat yoghurt) on homeostatic and gustatory brain regions. Read more about this study
- Who is it for?
- Ages 25 to 32 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fat Processing in the Brain
- What is being tested?
- intake of high or low fat yoghurt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Mar 2011
- 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 25 to 32 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- 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 Intake Modulates Cerebral Blood Flow in Homeostatic and Gustatory Brain Areas in Humans
The aim of the current study was to investigate the effect of a high versus a low fat meal (operationalized by high and low fat yoghurt) on homeostatic and gustatory brain regions.
- Conditions
- Fat Processing in the Brain
- Being tested
- intake of high or low fat yoghurt
- Keywords
- Fat ingestion, hypothalamus, insula, fMRI, CBF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intake of high or low fat yoghurtDietary supplement
intake of 500 ml of a high fat yoghurt on one day and intake of 500 ml of a low fat yoghurt on the other day
| Study group | Role | What they receive |
|---|---|---|
| high fat yoghurt intake | Experimental | 500 ml of a high fat yoghurt Receives: Dietary Supplement: intake of high or low fat yoghurt |
| low fat yoghurt intake | Experimental | Not described Receives: Dietary Supplement: intake of high or low fat yoghurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cerebral Blood Flow due to the high or low fat yoghurt intake after 30 minutes and 120 minutes compared to a baseline measurement 30 minutes before yoghurt intake.
We were interested in differential brain activations due to the high or low fat meal. To assess this, the mentioned time points are suitable.
The Cerebral Blood Flow is measured using Arterial Spin Labeling sequences in a functional magnetic resonance tomography.
Measured: 30 minutes before as well as 30 minutes and 120 minutes after fat intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startJan 2011
- Primary completionMar 2011
- Study completionMar 2011
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 Fat Processing in the BrainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation, German Federation of Industrial Research Associations, Zentrum für Ernährungsmedizin und Prävention, German Center for Diabetes Research, University of Hohenheim
- Responsible party
- Principal investigator, Sabine Frank, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516021
- Sponsor's protocol ID
- YOG
- Status last verified
- Jan 2012
- First submitted
- 9 Jan 2012
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Frank S, Linder K, Kullmann S, Heni M, Ketterer C, Cavusoglu M, Krzeminski A, Fritsche A, Haring HU, Preissl H, Hinrichs J, Veit R. Fat intake modulates cerebral blood flow in homeostatic and gustatory brain areas in humans. Am J Clin Nutr. 2012 Jun;95(6):1342-9. doi: 10.3945/ajcn.111.031492. Epub 2012 May 9.
PubMed 22572644
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fat Intake Modulates Cerebral Blood Flow in Homeostatic and Gustatory Brain Areas in Humans
- ClinicalTrials.gov ID
- NCT01516021
- Acronym / sponsor ID
- YOG
- Conditions
- Fat Processing in the Brain
- Keywords
- Fat ingestion, hypothalamus, insula, fMRI, CBF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- German Research Foundation, German Federation of Industrial Research Associations, Zentrum für Ernährungsmedizin und Prävention, German Center for Diabetes Research, University of Hohenheim
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 24 Jan 2012 (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 aim of the current study was to investigate the effect of a high versus a low fat meal (operationalized by high and low fat yoghurt) on homeostatic and gustatory brain regions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high fat yoghurt intake | Experimental | Dietary Supplement: intake of high or low fat yoghurt500 ml of a high fat yoghurt |
| low fat yoghurt intake | Experimental | Dietary Supplement: intake of high or low fat yoghurt |
Who may qualify
- Ages
- 25 to 32 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- male
- 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 |
|---|---|---|
| intake of high or low fat yoghurtintake of 500 ml of a high fat yoghurt on one day and intake of 500 ml of a low fat yoghurt on the other day | Dietary supplement | high fat yoghurt intake, low fat yoghurt intake |
Primary outcome
Changes in Cerebral Blood Flow due to the high or low fat yoghurt intake after 30 minutes and 120 minutes compared to a baseline measurement 30 minutes before yoghurt intake.
Time frame: 30 minutes before as well as 30 minutes and 120 minutes after fat intake
We were interested in differential brain activations due to the high or low fat meal. To assess this, the mentioned time points are suitable. The Cerebral Blood Flow is measured using Arterial Spin Labeling sequences in a functional magnetic resonance tomography.
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 24 Jan 2012.
- Derived from this study: PubMed 22572644Frank S, Linder K, Kullmann S, Heni M, Ketterer C, Cavusoglu M, Krzeminski A, Fritsche A, Haring HU, Preissl H, Hinrichs J, Veit R. Fat intake modulates cerebral blood flow in homeostatic and gustatory brain areas in humans. Am J Clin Nutr. 2012 Jun;95(6):1342-9. doi: 10.3945/ajcn.111.031492. Epub 2012 May 9.
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 intake of high or low fat yoghurt in people with Fat Processing 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 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 24 Jan 2012. 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?
Changes in Cerebral Blood Flow due to the high or low fat yoghurt intake after 30 minutes and 120 minutes compared to a baseline measurement 30 minutes before yoghurt intake. (time frame: 30 minutes before as well as 30 minutes and 120 minutes after fat intake). 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 NCT01516021, 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 24 Jan 2012.