Exploratory BehaviorNCT02255812
Taste Physiology in Healthy, Normal-weight Volunteers
A study testing Single intragastric instillation of 200 mL tap water via nasogastric tube, Single intragastric instillation of 2 g citric acid in 200 mL tap water via nasogastric tube and Single intragastric instillation of 2 g salt in 200 mL tap water via nasogastric tube in people with Exploratory Behavior, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Taste physiology describes five main taste qualities in humans: sweet, sour, salty, umami and bitter. The receptors found on the tongue are also found in the entire gut. The correlation of stimulation of these gut receptors and brain activity has not yet been examined. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exploratory Behavior
- What is being tested?
- Single intragastric instillation of 200 mL tap water via nasogastric tube, Single intragastric instillation of 2 g citric acid in 200 mL tap water via nasogastric tube and Single intragastric instillation of 2 g salt in 200 mL tap water via nasogastric tube
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2013to Oct 2013
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- right-handed healthy males
- Body-mass index of < 25
- Age 18-45 years
- no drugs
- non-smoking
Who cannot join
- Smoking
- Substance abuse
- Regular intake of medications (except for oral contraceptives)
- Medical or psychiatric illness, especially: diabetes, pace-maker, claustrophobia
- History of gastrointestinal disorders
- Food allergies, glutamate intolerance
- Body piercings that cannot be removed
Trial locations and contacts
1 site in 1 country.
About this study
Taste physiology describes five main taste qualities in humans: sweet, sour, salty, umami and bitter. The receptors found on the tongue are also found in the entire gut. The correlation of stimulation of these gut receptors and brain activity has not yet been examined. The objectives are to investigate the effect of different taste substances on i) regional brain activity and ii) satiation peptide release.
- Conditions
- Exploratory Behavior
- Being tested
- Single intragastric instillation of 200 mL tap water via nasogastric tube, Single intragastric instillation of 2 g citric acid in 200 mL tap water via nasogastric tube, Single intragastric instillation of 2 g salt in 200 mL tap water via nasogastric tube, Single intragastric instillation of 0.017 g quinine in 200 mL tap water via nasogastric tube, Single intragastric instillation of 1 g monosodium glutamate in 200 mL tap water via nasogastric tube
- Medical subject headings
- Exploratory Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single intragastric instillation of 200 mL tap water via nasogastric tubeDietary supplement
Single intragastric instillation of 2 g citric acid in 200 mL tap water via nasogastric tubeDietary supplement
Single intragastric instillation of 2 g salt in 200 mL tap water via nasogastric tubeDietary supplement
Single intragastric instillation of 0.017 g quinine in 200 mL tap water via nasogastric tubeDietary supplement
Single intragastric instillation of 1 g monosodium glutamate in 200 mL tap water via nasogastric tubeDietary supplement
Single intragastric instillation of 25 g glucose in 200 mL tap water via nasogastric tubeDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 200 mL tap water | Placebo comparator | Single intragastric instillation of 200 mL tap water via nasogastric tube Receives: Dietary Supplement: Single intragastric instillation of 200 mL tap water via nasogastric tube |
| 2 g citric acid | Active comparator | Single intragastric instillation of 2 g citric acid in 200 mL tap water via nasogastric tube Receives: Dietary Supplement: Single intragastric instillation of 2 g citric acid in 200 mL tap water via nasogastric tube |
| 2 g salt | Active comparator | Single intragastric instillation of 2 g salt in 200 mL tap water via nasogastric tube Receives: Dietary Supplement: Single intragastric instillation of 2 g salt in 200 mL tap water via nasogastric tube |
| 0.017 g quinine | Active comparator | Single intragastric instillation of 0.017 g quinine in 200 mL tap water via nasogastric tube Receives: Dietary Supplement: Single intragastric instillation of 0.017 g quinine in 200 mL tap water via nasogastric tube |
| 1 g monosodium glutamate | Active comparator | Single intragastric instillation of 1 g monosodium glutamate in 200 mL tap water via nasogastric tube Receives: Dietary Supplement: Single intragastric instillation of 1 g monosodium glutamate in 200 mL tap water via nasogastric tube |
| 25 g glucose | Active comparator | Single intragastric instillation of 25 g glucose in 200 mL tap water via nasogastric tube Receives: Dietary Supplement: Single intragastric instillation of 25 g glucose in 200 mL tap water via nasogastric tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
regional brain activity assessed by functional Magnetic Resonance Imaging (fMRI)
Changes in resting state functional connectivity
Measured: changes from baseline to one hour after treatment
Secondary outcomes (2)
gastrointestinal satiation peptide secretion
Unit of Measure: glucagon like peptide-1 (GLP-1) in pg/mL, peptide tyrosine tyrosine (PYY) in pg/mL and gastric inhibitory polypeptide (GIP) in pg/mL
Measured: changes from baseline to one hour after treatment
glucose and insulin secretion
Unit of Measure: glucose in mmol/L, insulin in μU/mL
Measured: changes from baseline to one hour after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startMar 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exploratory BehaviorStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Beglinger, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255812
- Sponsor's protocol ID
- EKBB 289/12/2
- Status last verified
- Sep 2014
- First submitted
- 6 Aug 2014
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taste Physiology in Healthy, Normal-weight Volunteers
- ClinicalTrials.gov ID
- NCT02255812
- Acronym / sponsor ID
- EKBB 289/12/2
- Conditions
- Exploratory Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 3 Oct 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.
Taste physiology describes five main taste qualities in humans: sweet, sour, salty, umami and bitter. The receptors found on the tongue are also found in the entire gut. The correlation of stimulation of these gut receptors and brain activity has not yet been examined. The objectives are to investigate the effect of different taste substances on i) regional brain activity and ii) satiation peptide release.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 200 mL tap water | Placebo comparator | Dietary Supplement: Single intragastric instillation of 200 mL tap water via nasogastric tubeSingle intragastric instillation of 200 mL tap water via nasogastric tube |
| 2 g citric acid | Active comparator | Dietary Supplement: Single intragastric instillation of 2 g citric acid in 200 mL tap water via nasogastric tubeSingle intragastric instillation of 2 g citric acid in 200 mL tap water via nasogastric tube |
| 2 g salt | Active comparator | Dietary Supplement: Single intragastric instillation of 2 g salt in 200 mL tap water via nasogastric tubeSingle intragastric instillation of 2 g salt in 200 mL tap water via nasogastric tube |
| 0.017 g quinine | Active comparator | Dietary Supplement: Single intragastric instillation of 0.017 g quinine in 200 mL tap water via nasogastric tubeSingle intragastric instillation of 0.017 g quinine in 200 mL tap water via nasogastric tube |
| 1 g monosodium glutamate | Active comparator | Dietary Supplement: Single intragastric instillation of 1 g monosodium glutamate in 200 mL tap water via nasogastric tubeSingle intragastric instillation of 1 g monosodium glutamate in 200 mL tap water via nasogastric tube |
| 25 g glucose | Active comparator | Dietary Supplement: Single intragastric instillation of 25 g glucose in 200 mL tap water via nasogastric tubeSingle intragastric instillation of 25 g glucose in 200 mL tap water via nasogastric tube |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- right-handed healthy males
- Body-mass index of < 25
- Age 18-45 years
- no drugs
- non-smoking
Key exclusion criteria (7 listed)
- Smoking
- Substance abuse
- Regular intake of medications (except for oral contraceptives)
- Medical or psychiatric illness, especially: diabetes, pace-maker, claustrophobia
- History of gastrointestinal disorders
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 |
|---|---|---|
| Single intragastric instillation of 200 mL tap water via nasogastric tube | Dietary supplement | 200 mL tap water |
| Single intragastric instillation of 2 g citric acid in 200 mL tap water via nasogastric tube | Dietary supplement | 2 g citric acid |
| Single intragastric instillation of 2 g salt in 200 mL tap water via nasogastric tube | Dietary supplement | 2 g salt |
| Single intragastric instillation of 0.017 g quinine in 200 mL tap water via nasogastric tube | Dietary supplement | 0.017 g quinine |
| Single intragastric instillation of 1 g monosodium glutamate in 200 mL tap water via nasogastric tube | Dietary supplement | 1 g monosodium glutamate |
| Single intragastric instillation of 25 g glucose in 200 mL tap water via nasogastric tube | Dietary supplement | 25 g glucose |
Primary outcome
regional brain activity assessed by functional Magnetic Resonance Imaging (fMRI)
Time frame: changes from baseline to one hour after treatment
Changes in resting state functional connectivity
2 secondary outcomes
gastrointestinal satiation peptide secretion
Time frame: changes from baseline to one hour after treatment
glucose and insulin secretion
Time frame: changes from baseline to one hour after treatment
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 3 Oct 2014.
Related trials for Exploratory Behavior
RecruitingPhase 2
An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Persons With REM Sleep Behavior Disorder (RBD)
REM Sleep Behavior Disorder
Enrolling by invitation
Efficacy of Repetitive Transcranial Magnetic Stimulation for Improving Depressive Symptoms in Patients With Parkinson's Disease
Parkinson's Disease, Depression
Not yet recruiting
Effects of Ashwagandha Supplementation on Quality of Life and Well-Being in Women With Endometriosis
Endometriosis, Quality of Life
Active, not recruiting
Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplantation
Recruiting
A Novel Digital Tool Clinicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors
Hypertension, Dyslipidemia
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.
Christoph Beglinger, MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single intragastric instillation of 200 mL tap water via nasogastric tube, Single intragastric instillation of 2 g citric acid in 200 mL tap water via nasogastric tube and Single intragastric instillation of 2 g salt in 200 mL tap water via nasogastric tube in people with Exploratory Behavior, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 5 inclusion and 7 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 3 Oct 2014. 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 Switzerland. 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. 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?
regional brain activity assessed by functional Magnetic Resonance Imaging (fMRI) (time frame: changes from baseline to one hour after treatment). 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 3 Oct 2014.