HealthyNCT02946970
Brain Responses to Intragastric Administration of a Bitter Agonist in Homeostatic and Hedonic Brain Regions
A study testing Quinine hydrochloride in people with Healthy, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
The investigators aim to study the brain mechanisms underlying the effect of subliminal (not consciously perceived) intragastric administration of bitter tastants on hunger and food intake, which was previously found. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Quinine hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jan 2016
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- Female
- N = 15
- Age 18 - 60
- Body Mass Index (BMI) of 20 - 25 kg/m
- Stable body weight for at least 3 months prior to the start of the study
Who cannot join
- Abdominal or thoracic surgery. Exception: appendectomy
- Gastrointestinal, endocrine or neurological diseases
- Cardiovascular, respiratory, renal or urinary diseases
- Hypertension
- Food or drug allergies
- Anemia
Show all 16Show fewer
- Eating disorders and people who show abnormal eating behavior
- Depressive disorders
- Psychotic disorders
- No medication on a regular basis, expect for oral contraception
- Conditions that can interfere with functional magnetic resonance imaging (fMRI), e.g. cochlear implants, metal fragments or metal implants in the body, pacemaker, neural stimulator, …
- No history of cannabis use or any other drug of abuse for at least 12 months prior to the study
- Alcohol abuse (more than 21 units of alcohol for men, more than 14 units for woman per week)
- Dieters
- Pregnant or breastfeeding women
- Claustrophobia
About this study
The investigators aim to study the brain mechanisms underlying the effect of subliminal (not consciously perceived) intragastric administration of bitter tastants on hunger and food intake, which was previously found. The investigators will assess brain activation patterns after an acute intragastric administration of Quinine-hydrochloride versus saline on two different test days, and will simultaneously assess a putative role of altered gut peptide release in these effects. The hypothesis is that intragastric infusion of a bitter agonist will decrease the activity in homeostatic and hedonic brain regions and that this effect is mediated by gut peptide release.
- Conditions
- Healthy
- Being tested
- Quinine hydrochloride, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quinine hydrochlorideOther
Intragastric administration of a bitter tastant agonist (10 μmol/kg quinine-hydrochloride)
ControlOther
Intragastric administration of distilled water
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Intragastric infusion Receives: Other: Control |
| Quinine hydrochloride | Experimental | Intragastric infusion Receives: Other: Quinine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional brain images
Change in brain responses after administration compared to baseline will be assessed via functional magnetic resonance imaging.
Measured: From the start of the study until 50 minutes after the start of the study
Secondary outcomes (6)
hunger scores
The hunger scores will be taken every 10 minutes since the scan starts via a 10 cm visual analogue scale.
Measured: every 10 minutes since the scan starts until until 50 minutes after the start of the scan
Ghrelin levels
Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure ghrelin levels by radioimmuno-assay.
Measured: every 10 min since the scan starts until 50 minutes after the start of the scan.
Motilin levels
Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure motilin levels by radioimmuno-assay.
Measured: every 10 min since the scan starts until 50 minutes after the start of the scan
CCK levels
Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure CCK levels by radioimmuno-assay.
Measured: every 10 min since the scan starts until 50 minutes after the start of the scan
PYY levels
Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure PYY levels by Enzyme-Linked Immuno Sorbent Assay
Measured: every 10 min since the scan starts until 50 minutes after the start of the scan
GLP-1 levels
Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure GLP-1 levels by Enzyme-Linked Immuno Sorbent Assay
Measured: every 10 min since the scan starts until 50 minutes after the start of the scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startSep 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Tack, Prof, Principal investigator, University of Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946970
- Sponsor's protocol ID
- S57915
- Status last verified
- May 2016
- First submitted
- 12 May 2016
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Responses to Intragastric Administration of a Bitter Agonist in Homeostatic and Hedonic Brain Regions
- ClinicalTrials.gov ID
- NCT02946970
- Acronym / sponsor ID
- S57915
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 27 Oct 2016 (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 investigators aim to study the brain mechanisms underlying the effect of subliminal (not consciously perceived) intragastric administration of bitter tastants on hunger and food intake, which was previously found. The investigators will assess brain activation patterns after an acute intragastric administration of Quinine-hydrochloride versus saline on two different test days, and will simultaneously assess a putative role of altered gut peptide release in these effects. The hypothesis is that intragastric infusion of a bitter agonist will decrease the activity in homeostatic and hedonic brain regions and that this effect is mediated by gut peptide release.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: ControlIntragastric infusion |
| Quinine hydrochloride | Experimental | Other: Quinine hydrochlorideIntragastric infusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy volunteers
- Female
- N = 15
- Age 18 - 60
- Body Mass Index (BMI) of 20 - 25 kg/m
Key exclusion criteria (16 listed)
- Abdominal or thoracic surgery. Exception: appendectomy
- Gastrointestinal, endocrine or neurological diseases
- Cardiovascular, respiratory, renal or urinary diseases
- Hypertension
- Food or drug allergies
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 |
|---|---|---|
| Quinine hydrochlorideIntragastric administration of a bitter tastant agonist (10 μmol/kg quinine-hydrochloride) | Other | Quinine hydrochloride |
| ControlIntragastric administration of distilled water | Other | Control |
Primary outcome
Functional brain images
Time frame: From the start of the study until 50 minutes after the start of the study
Change in brain responses after administration compared to baseline will be assessed via functional magnetic resonance imaging.
6 secondary outcomes
hunger scores
Time frame: every 10 minutes since the scan starts until until 50 minutes after the start of the scan
Ghrelin levels
Time frame: every 10 min since the scan starts until 50 minutes after the start of the scan.
Motilin levels
Time frame: every 10 min since the scan starts until 50 minutes after the start of the scan
CCK levels
Time frame: every 10 min since the scan starts until 50 minutes after the start of the scan
PYY levels
Time frame: every 10 min since the scan starts until 50 minutes after the start of the scan
GLP-1 levels
Time frame: every 10 min since the scan starts until 50 minutes after the start of the scan
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 27 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Jan Tack, Prof principal investigator
University of Leuven
Questions about this trial
What is this clinical trial studying?
A study testing Quinine hydrochloride in people with Healthy, run by Universitaire Ziekenhuizen KU Leuven.
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 6 inclusion and 16 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 27 Oct 2016. 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. Some participants in this study may receive a placebo. 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?
Functional brain images (time frame: From the start of the study until 50 minutes after the start of the study). 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 27 Oct 2016.