Taste Disorder, Secondary, SweetPhase 1NCT01302574
Role of the Gut Sweet Taste Receptor in the Secretion of Satiation Peptides
A Phase 1 study testing lactisole in people with Taste Disorder, Secondary, Sweet, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine the functional significance of sweet taste receptors in the secretion of gastrointestinal (GI) satiation peptides by using a specific sweet taste receptor antagonist to block sweet taste perception in the gastrointestinal tract. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Taste Disorder, Secondary, Sweet
- What is being tested?
- lactisole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Jun 2010
- Phase
- Phase 1
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects
- BMI of 19.0-24.5
- age 18-40 years old
- stable body weight for at least 3 month
Who cannot join
- smoking
- substance abuse
- regular intake of medication
- medical or psychiatric illness
- gastrointestinal disorders or food allergies
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Phase 1 Research Unit
Basel, 4031
About this study
Official title: The Role of Sweet Taste Receptor Blockade on Intragastric Liquid Meal-stimulated Secretion of Satiation Peptides in Healthy Humans
The purpose of this study is to determine the functional significance of sweet taste receptors in the secretion of gastrointestinal (GI) satiation peptides by using a specific sweet taste receptor antagonist to block sweet taste perception in the gastrointestinal tract.
Read the detailed description
There is strong evidence that taste signaling mechanisms identified in the oral epithelium also operate in the gut. It is suggested that open-type enteroendocrine cells directly sense nutrient via alpha-gustducin coupled taste receptors to modulate the secretion of glucagon like peptide-1 (GLP-1) and peptide YY (PYY). Several nutrient responsive G-protein coupled receptors have been identified in the human gut, including the sweet taste responsive T1R2/T1R3 heterodimer, the amino acid/umami responsive T1R1/T1R3 as well as GPR120 for unsaturated long-chain free fatty acids. The functional significance of sweet taste receptors in mixed liquid meal-stimulated secretion of GLP-1 and PYY will be determined by intragastric infusion of a 500 mL mixed liquid meal with or without lactisole (450 ppm)in a double blind, 2-way crossover trial including 16 healthy subjects.
- Conditions
- Taste Disorder, Secondary, Sweet
- Being tested
- lactisole
- Keywords
- T1R2/T1R3, gastric emptying, gut, lactisole, nutrient sensing
- Medical subject headings
- Taste Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lactisoleDietary supplement
Also called Dietary supplement
Lactisole-liquid meal: Lactisole (450 ppm) will be mixed with a liquid meal. Liquid meal only: The comparator will be the liquid meal alone.
| Study group | Role | What they receive |
|---|---|---|
| mixed liquid meal | Placebo comparator | 500 mL mixed liquid meal + 50 mg 13C-sodium-acetate Receives: Dietary Supplement: lactisole |
| mixed liquid meal + lactisole | Active comparator | 500 mL mixed liquid meal + 50 mg 13C-sodium-acetate + 450 ppm lactisole Receives: Dietary Supplement: lactisole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal peptide secretion
Measured: 2 hours blood sampling
Secondary outcomes (2)
Appetite perceptions
Measured: 4 hours
Gastric emptying rate
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startJan 2010
- Primary completionMar 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Taste Disorder, Secondary, SweetStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Christoph Beglinger, MD, Principal investigator, Phase 1 Research Unit, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302574
- Sponsor's protocol ID
- EKBB 69/04.02
- Status last verified
- Feb 2011
- First submitted
- 22 Feb 2011
- Last updated
- 24 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sweet Taste Receptor Blockade on Intragastric Liquid Meal-stimulated Secretion of Satiation Peptides in Healthy Humans
- ClinicalTrials.gov ID
- NCT01302574
- Acronym / sponsor ID
- EKBB 69/04.02
- Conditions
- Taste Disorder, Secondary, Sweet
- Keywords
- T1R2/T1R3, gastric emptying, gut, lactisole, nutrient sensing
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 24 Feb 2011 (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 purpose of this study is to determine the functional significance of sweet taste receptors in the secretion of gastrointestinal (GI) satiation peptides by using a specific sweet taste receptor antagonist to block sweet taste perception in the gastrointestinal tract.
Detailed description
There is strong evidence that taste signaling mechanisms identified in the oral epithelium also operate in the gut. It is suggested that open-type enteroendocrine cells directly sense nutrient via alpha-gustducin coupled taste receptors to modulate the secretion of glucagon like peptide-1 (GLP-1) and peptide YY (PYY). Several nutrient responsive G-protein coupled receptors have been identified in the human gut, including the sweet taste responsive T1R2/T1R3 heterodimer, the amino acid/umami responsive T1R1/T1R3 as well as GPR120 for unsaturated long-chain free fatty acids. The functional significance of sweet taste receptors in mixed liquid meal-stimulated secretion of GLP-1 and PYY will be determined by intragastric infusion of a 500 mL mixed liquid meal with or without lactisole (450 ppm)in a double blind, 2-way crossover trial including 16 healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mixed liquid meal | Placebo comparator | Dietary Supplement: lactisole500 mL mixed liquid meal + 50 mg 13C-sodium-acetate |
| mixed liquid meal + lactisole | Active comparator | Dietary Supplement: lactisole500 mL mixed liquid meal + 50 mg 13C-sodium-acetate + 450 ppm lactisole |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy subjects
- BMI of 19.0-24.5
- age 18-40 years old
- stable body weight for at least 3 month
Key exclusion criteria (5 listed)
- smoking
- substance abuse
- regular intake of medication
- medical or psychiatric illness
- gastrointestinal disorders or food 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 |
|---|---|---|
| lactisoleAlso: Dietary supplementLactisole-liquid meal: Lactisole (450 ppm) will be mixed with a liquid meal. Liquid meal only: The comparator will be the liquid meal alone. | Dietary supplement | mixed liquid meal, mixed liquid meal + lactisole |
Primary outcome
Gastrointestinal peptide secretion
Time frame: 2 hours blood sampling
2 secondary outcomes
Appetite perceptions
Time frame: 4 hours
Gastric emptying rate
Time frame: 4 hours
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 Feb 2011.
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
Phase 1 Research Unit, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lactisole in people with Taste Disorder, Secondary, Sweet, 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 4 inclusion and 5 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 Feb 2011. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Gastrointestinal peptide secretion (time frame: 2 hours blood sampling). 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 24 Feb 2011.