Taste Disorder, Primary, SweetPhase 1NCT01304823
Role of the Gut Sweet Taste Receptor in the Secretion of Glucagon-like Peptide-1 and Peptide YY
A Phase 1 study testing lactisole and mixed liquid meal in people with Taste Disorder, Primary, 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 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 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Taste Disorder, Primary, Sweet
- What is being tested?
- lactisole and mixed liquid meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2010to Jan 2011
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- BMI of 19.0-24.5
- Age 18-40
- 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 Intraduodenal Glucose- and 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 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 the secretion of GLP-1 and PYY will be determined by intraduodenal perfusion of glucose (I) or a mixed liquid meal (II) with or without lactisole (450 ppm) in a double blind, 5-way crossover trial including 10 healthy subjects.
- Conditions
- Taste Disorder, Primary, Sweet
- Being tested
- lactisole, mixed liquid meal
- 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
flavoring agent/sweet taste antagonist
mixed liquid mealOther
Also called Dietary supplement
Ensure Plus
| Study group | Role | What they receive |
|---|---|---|
| glucose | Active comparator | intraduodenal perfusion of glucose (29.3 g glucose per 100 mL; rate: 2.5 mL/min for 180 min; caloric load: 3.0 kcal/min) Receives: Dietary Supplement: lactisole |
| glucose + lactisole | Active comparator | intraduodenal perfusion of glucose (29.3 g glucose per 100 mL; rate: 2.5 mL/min for 180 min; caloric load: 3.0 kcal/min) + 450 ppm lactisole Receives: Dietary Supplement: lactisole |
| mixed liquid meal | Active comparator | intraduodenal perfusion of a mixed liquid meal (20.20 g carbohydrate, 4.92 g fat and 6.25 g protein per 100 mL; rate: 2.5 mL/min for 180 min; caloric load: 3.0 kcal/min) Receives: Other: mixed liquid meal |
| mixed liquid meal + lactisole | Active comparator | intraduodenal perfusion of a mixed liquid meal (20.20 g carbohydrate, 4.92 g fat and 6.25 g protein per 100 mL; rate: 2.5 mL/min for 180 min; caloric load: 3.0 kcal/min) + 450 ppm lactisole Receives: Other: mixed liquid meal |
| saline + lactisole | Placebo comparator | saline (0.9 %; rate: 2.5 mL/min for 180 min) + 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
Assessment of venous GLP-1 and PYY release to meal stimulation with and without sweet receptor blockade
Measured: 4 hours blood sampling
Secondary outcomes (1)
Appetite perceptions during 4 hours using VAS
Assessment of the following appetite perception markers: feelings of hunger, feelings of fullness, feelings of satiety using validated visual analogue scales
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 posted25 Feb 2011 (estimated)
- Study startJun 2010
- Primary completionAug 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Taste Disorder, Primary, 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
- 10 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, Phase 1 Research Unit, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304823
- Sponsor's protocol ID
- EKBB 69/04.03
- Status last verified
- Jul 2015
- First submitted
- 22 Feb 2011
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Steinert RE, Meyer-Gerspach AC, Beglinger C. The role of the stomach in the control of appetite and the secretion of satiation peptides. Am J Physiol Endocrinol Metab. 2012 Mar 15;302(6):E666-73. doi: 10.1152/ajpendo.00457.2011. Epub 2012 Jan 3.
PubMed 22215654Steinert RE, Gerspach AC, Gutmann H, Asarian L, Drewe J, Beglinger C. The functional involvement of gut-expressed sweet taste receptors in glucose-stimulated secretion of glucagon-like peptide-1 (GLP-1) and peptide YY (PYY). Clin Nutr. 2011 Aug;30(4):524-32. doi: 10.1016/j.clnu.2011.01.007. Epub 2011 Feb 15.
PubMed 21324568
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sweet Taste Receptor Blockade on Intraduodenal Glucose- and Liquid Meal-stimulated Secretion of Satiation Peptides in Healthy Humans
- ClinicalTrials.gov ID
- NCT01304823
- Acronym / sponsor ID
- EKBB 69/04.03
- Conditions
- Taste Disorder, Primary, Sweet
- Keywords
- T1R2/T1R3, gastric emptying, gut, lactisole, nutrient sensing
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 25 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 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 the secretion of GLP-1 and PYY will be determined by intraduodenal perfusion of glucose (I) or a mixed liquid meal (II) with or without lactisole (450 ppm) in a double blind, 5-way crossover trial including 10 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
- 5
| Arm | Type | Receives |
|---|---|---|
| glucose | Active comparator | Dietary Supplement: lactisoleintraduodenal perfusion of glucose (29.3 g glucose per 100 mL; rate: 2.5 mL/min for 180 min; caloric load: 3.0 kcal/min) |
| glucose + lactisole | Active comparator | Dietary Supplement: lactisoleintraduodenal perfusion of glucose (29.3 g glucose per 100 mL; rate: 2.5 mL/min for 180 min; caloric load: 3.0 kcal/min) + 450 ppm lactisole |
| mixed liquid meal | Active comparator | Other: mixed liquid mealintraduodenal perfusion of a mixed liquid meal (20.20 g carbohydrate, 4.92 g fat and 6.25 g protein per 100 mL; rate: 2.5 mL/min for 180 min; caloric load: 3.0 kcal/min) |
| mixed liquid meal + lactisole | Active comparator | Other: mixed liquid mealintraduodenal perfusion of a mixed liquid meal (20.20 g carbohydrate, 4.92 g fat and 6.25 g protein per 100 mL; rate: 2.5 mL/min for 180 min; caloric load: 3.0 kcal/min) + 450 ppm lactisole |
| saline + lactisole | Placebo comparator | Dietary Supplement: lactisolesaline (0.9 %; rate: 2.5 mL/min for 180 min) + 450 ppm lactisole |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects
- BMI of 19.0-24.5
- Age 18-40
- 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 supplementflavoring agent/sweet taste antagonist | Dietary supplement | glucose, glucose + lactisole, saline + lactisole |
| mixed liquid mealAlso: Dietary supplementEnsure Plus | Other | mixed liquid meal, mixed liquid meal + lactisole |
Primary outcome
Gastrointestinal peptide secretion
Time frame: 4 hours blood sampling
Assessment of venous GLP-1 and PYY release to meal stimulation with and without sweet receptor blockade
1 secondary outcome
Appetite perceptions during 4 hours using VAS
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 16 Jul 2015.
- Results publication: PubMed 22215654Steinert RE, Meyer-Gerspach AC, Beglinger C. The role of the stomach in the control of appetite and the secretion of satiation peptides. Am J Physiol Endocrinol Metab. 2012 Mar 15;302(6):E666-73. doi: 10.1152/ajpendo.00457.2011. Epub 2012 Jan 3.
- Results publication: PubMed 21324568Steinert RE, Gerspach AC, Gutmann H, Asarian L, Drewe J, Beglinger C. The functional involvement of gut-expressed sweet taste receptors in glucose-stimulated secretion of glucagon-like peptide-1 (GLP-1) and peptide YY (PYY). Clin Nutr. 2011 Aug;30(4):524-32. doi: 10.1016/j.clnu.2011.01.007. Epub 2011 Feb 15.
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 and mixed liquid meal in people with Taste Disorder, Primary, 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 16 Jul 2015. 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: 4 hours blood sampling). 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 NCT01304823, which also lists 2 linked publications.
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 16 Jul 2015.