Treatment of Sweet Taste Receptors Without or With an Oral Rinse of Ibuprofen Solution in Healthy ParticipantsNCT06291337
Ibuprofen Inhibits Human Sweet Taste
A study testing Inhibition of Sweet Taste by Ibuprofen Oral Rinses and Inhibition of Sweet Taste by Naproxen Oral Rinses in people with Treatment of Sweet Taste Receptors Without or With an Oral Rinse of Ibuprofen Solution in Healthy Participants and Treatment of Sweet Taste Receptors Without or With an Oral Rinse of Naproxen Solution in Healthy Participants, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The sweet taste receptor, TAS1R2-TAS1R3, is expressed both orally, where it signals sweet taste, and extraorally in the intestine and pancreas, where it may affect glucose absorption and metabolism. Recently, ibuprofen and naproxen have been identified to inhibit human T1R3 when heterologously expressed in cells. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment of Sweet Taste Receptors Without or With an Oral Rinse of Ibuprofen Solution in Healthy Participants, Treatment of Sweet Taste Receptors Without or With an Oral Rinse of Naproxen Solution in Healthy Participants
- What is being tested?
- Inhibition of Sweet Taste by Ibuprofen Oral Rinses and Inhibition of Sweet Taste by Naproxen Oral Rinses
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 30 Sep 2023
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must be able to taste sugars as sweet
- Participant must be able to make ratings on a scale and follow instructions
Who cannot join
- Participant must not be on any medications that would preclude exposure to NSAIDS
- Participant must not be on any medications that are know to alter taste perception
Trial locations and contacts
1 site in 1 country.
United States1 site
Food Science and Nutritional Sciences
New Brunswick, New Jersey, 08901
About this study
Official title: Ibuprofen, a Phenylpropanoic Acid Nonsteroidal Anti-inflammatory Drug, Inhibits Human Sweet Taste and Glucose Detection
The sweet taste receptor, TAS1R2-TAS1R3, is expressed both orally, where it signals sweet taste, and extraorally in the intestine and pancreas, where it may affect glucose absorption and metabolism. Recently, ibuprofen and naproxen have been identified to inhibit human T1R3 when heterologously expressed in cells. In the present study, the initial objective was to determine if ibuprofen and naproxen inhibit interactions of sugars with human sweet taste receptor under normal, physiological conditions. Ten healthy participants were asked to rate sweetness intensity for a range of sweet stimuli (sucrose, fructose, sucralose) after a prerinse of ibuprofen, naproxen or water. Both ibuprofen and naproxen inhibited sweet taste intensity in a dose-dependent manner. In association studies, ibuprofen use has been linked to preserved metabolic function, as its use is correlated with lower rates of Alzheimer's disease, diabetes and colon cancer. Here the investigators present a potential novel pathway for systemic ibuprofen to impact these metabolic diseases.
Read the detailed description
The sweet taste receptor, TAS1R2-TAS1R3, is expressed both orally, where it signals sweet taste, and extraorally in the intestine and pancreas, where it may affect glucose absorption and metabolism. Lactisole is a well characterized negative allosteric modulator of the transmembrane domain of T1R3. Lactisole binds with a phenylpropionic acid moiety. More recently, ibuprofen and naproxen, which are similar to lactisole in structure, have been identified to inhibit human T1R3 when heterologously expressed in cells. In the present study, the initial objective was to determine if ibuprofen and naproxen inhibit interactions of sugars with human sweet taste receptor under normal, physiological conditions. Ten healthy participants were asked to rate sweetness intensity for a range of sweet stimuli (sucrose, fructose, sucralose) after a prerinse of ibuprofen, naproxen or water. Both ibuprofen and naproxen inhibited sweet taste intensity in a dose-dependent manner. The experiment was repeated in vitro with TAS1R2-TAS1R3 expressing human cells, with ibuprofen reducing signaling of sucrose and sucralose. To explore ibuprofen's potential connection with glucose signaling and metabolism, the investigators next tested whether prerinses of lower concentrations of ibuprofen including a typical peak plasma concentrations (0.18 mM, 0.57 mM and 5.7 mM), would affect sweet taste intensity ratings of lower levels of glucose. Ibuprofen inhibited glucose sweetness in a dose dependent manner. Finally, the investigators tested whether prerinses of 0.12 mM and 0.24 mM ibuprofen (resulting from ingestion of two or three 200 mg pills respectively) affects detection thresholds of glucose, which are concentrations nearing post-prandial plasma glucose levels. Detection thresholds were significantly higher after rinsing with 0.24 mM ibuprofen compared to water rinses (p<0.01, n=12). In association studies, ibuprofen use has been linked to preserved metabolic function, as its use is correlated with lower rates of Alzheimer's disease, diabetes and colon cancer. Here the investigators present a potential novel pathway for systemic ibuprofen to impact these metabolic diseases.
- Conditions
- Treatment of Sweet Taste Receptors Without or With an Oral Rinse of Ibuprofen Solution in Healthy Participants, Treatment of Sweet Taste Receptors Without or With an Oral Rinse of Naproxen Solution in Healthy Participants
- Being tested
- Inhibition of Sweet Taste by Ibuprofen Oral Rinses, Inhibition of Sweet Taste by Naproxen Oral Rinses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhibition of Sweet Taste by Ibuprofen Oral RinsesDrug
Participants rinse the mouth with ibuprofen and the impact on perceived sweet taste elicited by sugar solutions in the mouth was assessed
Inhibition of Sweet Taste by Naproxen Oral RinsesDrug
Participants rinse the mouth with naproxen and the impact on perceived sweet taste elicited by sugar solutions in the mouth was assessed
| Study group | Role | What they receive |
|---|---|---|
| Treatment of sweet taste receptors with Ibuprofen oral rinse | Experimental | Participants were tested for sweetness perception without and with an oral rinse of ibuprofen. Receives: Drug: Inhibition of Sweet Taste by Ibuprofen Oral Rinses |
| Treatment of sweet taste receptors with naproxen oral rinse | Experimental | Participants were tested for sweetness perception without and with an oral rinse of naproxen. Receives: Drug: Inhibition of Sweet Taste by Naproxen Oral Rinses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sweet taste ratings
The impact of oral rinses with NSAIDS on sweet taste ratings of sugars on a labeled magnitude scale was assessed. The numeric outcome is the value of sweetness intensity provided by the participant from the labeled magnitude scale with each sweetener oral rinse.
Measured: 6 months
Sugar detection thresholds
The impact of oral rinses with NSAIDS on detection thresholds for sugars was assessed. The detection threshold is the lowest concentration of the sweetener solution that can be distinguished from water. The numeric outcome is the concentration of sweetener solution that can be distinguished from water.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Jun 2020
- Primary completion1 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Sweet Taste Receptors Without or With an Oral Rinse of Ibuprofen Solution in Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- We are testing individual sin a within subject control for their sweet taste ratings of sugars without and with oral rinses of ibuprofen and naproxen.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Monell Chemical Senses Center
- Responsible party
- Principal investigator, Paul A Breslin, Rutgers, The State University of New Jersey
- Investigators
- Paul A Breslin, Ph.D., Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291337
- Sponsor's protocol ID
- Pro2019001483
- Other IDs
- 10-204Mc
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibuprofen, a Phenylpropanoic Acid Nonsteroidal Anti-inflammatory Drug, Inhibits Human Sweet Taste and Glucose Detection
- ClinicalTrials.gov ID
- NCT06291337
- Acronym / sponsor ID
- Pro2019001483
- Conditions
- Treatment of Sweet Taste Receptors Without or With an Oral Rinse of Ibuprofen Solution in Healthy Participants, Treatment of Sweet Taste Receptors Without or With an Oral Rinse of Naproxen Solution in Healthy Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Monell Chemical Senses Center
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 4 Mar 2024 (actual)
- 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 sweet taste receptor, TAS1R2-TAS1R3, is expressed both orally, where it signals sweet taste, and extraorally in the intestine and pancreas, where it may affect glucose absorption and metabolism. Recently, ibuprofen and naproxen have been identified to inhibit human T1R3 when heterologously expressed in cells. In the present study, the initial objective was to determine if ibuprofen and naproxen inhibit interactions of sugars with human sweet taste receptor under normal, physiological conditions. Ten healthy participants were asked to rate sweetness intensity for a range of sweet stimuli (sucrose, fructose, sucralose) after a prerinse of ibuprofen, naproxen or water. Both ibuprofen and naproxen inhibited sweet taste intensity in a dose-dependent manner. In association studies, ibuprofen use has been linked to preserved metabolic function, as its use is correlated with lower rates of Alzheimer's disease, diabetes and colon cancer. Here the investigators present a potential novel pathway for systemic ibuprofen to impact these metabolic diseases.
Detailed description
The sweet taste receptor, TAS1R2-TAS1R3, is expressed both orally, where it signals sweet taste, and extraorally in the intestine and pancreas, where it may affect glucose absorption and metabolism. Lactisole is a well characterized negative allosteric modulator of the transmembrane domain of T1R3. Lactisole binds with a phenylpropionic acid moiety. More recently, ibuprofen and naproxen, which are similar to lactisole in structure, have been identified to inhibit human T1R3 when heterologously expressed in cells. In the present study, the initial objective was to determine if ibuprofen and naproxen inhibit interactions of sugars with human sweet taste receptor under normal, physiological conditions. Ten healthy participants were asked to rate sweetness intensity for a range of sweet stimuli (sucrose, fructose, sucralose) after a prerinse of ibuprofen, naproxen or water. Both ibuprofen and naproxen inhibited sweet taste intensity in a dose-dependent manner. The experiment was repeated in vitro with TAS1R2-TAS1R3 expressing human cells, with ibuprofen reducing signaling of sucrose and sucralose. To explore ibuprofen's potential connection with glucose signaling and metabolism, the investigators next tested whether prerinses of lower concentrations of ibuprofen including a typical peak plasma concentrations (0.18 mM, 0.57 mM and 5.7 mM), would affect sweet taste intensity ratings of lower levels of glucose. Ibuprofen inhibited glucose sweetness in a dose dependent manner. Finally, the investigators tested whether prerinses of 0.12 mM and 0.24 mM ibuprofen (resulting from ingestion of two or three 200 mg pills respectively) affects detection thresholds of glucose, which are concentrations nearing post-prandial plasma glucose levels. Detection thresholds were significantly higher after rinsing with 0.24 mM ibuprofen compared to water rinses (p<0.01, n=12). In association studies, ibuprofen use has been linked to preserved metabolic function, as its use is correlated with lower rates of Alzheimer's disease, diabetes and colon cancer. Here the investigators present a potential novel pathway for systemic ibuprofen to impact these metabolic diseases.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We are testing individual sin a within subject control for their sweet taste ratings of sugars without and with oral rinses of ibuprofen and naproxen.
| Arm | Type | Receives |
|---|---|---|
| Treatment of sweet taste receptors with Ibuprofen oral rinse | Experimental | Drug: Inhibition of Sweet Taste by Ibuprofen Oral RinsesParticipants were tested for sweetness perception without and with an oral rinse of ibuprofen. |
| Treatment of sweet taste receptors with naproxen oral rinse | Experimental | Drug: Inhibition of Sweet Taste by Naproxen Oral RinsesParticipants were tested for sweetness perception without and with an oral rinse of naproxen. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant must be able to taste sugars as sweet
- Participant must be able to make ratings on a scale and follow instructions
Key exclusion criteria (2 listed)
- Participant must not be on any medications that would preclude exposure to NSAIDS
- Participant must not be on any medications that are know to alter taste perception
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 |
|---|---|---|
| Inhibition of Sweet Taste by Ibuprofen Oral RinsesParticipants rinse the mouth with ibuprofen and the impact on perceived sweet taste elicited by sugar solutions in the mouth was assessed | Drug | Treatment of sweet taste receptors with Ibuprofen oral rinse |
| Inhibition of Sweet Taste by Naproxen Oral RinsesParticipants rinse the mouth with naproxen and the impact on perceived sweet taste elicited by sugar solutions in the mouth was assessed | Drug | Treatment of sweet taste receptors with naproxen oral rinse |
Primary outcome
Sweet taste ratings
Time frame: 6 months
The impact of oral rinses with NSAIDS on sweet taste ratings of sugars on a labeled magnitude scale was assessed. The numeric outcome is the value of sweetness intensity provided by the participant from the labeled magnitude scale with each sweetener oral rinse.
Sugar detection thresholds
Time frame: 6 months
The impact of oral rinses with NSAIDS on detection thresholds for sugars was assessed. The detection threshold is the lowest concentration of the sweetener solution that can be distinguished from water. The numeric outcome is the concentration of sweetener solution that can be distinguished from water.
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 4 Mar 2024.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after de-identification.
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.
Paul A Breslin, Ph.D. principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhibition of Sweet Taste by Ibuprofen Oral Rinses and Inhibition of Sweet Taste by Naproxen Oral Rinses in people with Treatment of Sweet Taste Receptors Without or With an Oral Rinse of Ibuprofen Solution in Healthy Participants and Treatment of Sweet Taste Receptors Without or With an Oral Rinse of Naproxen Solution in Healthy Participants, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 4 Mar 2024. 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 United States. 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?
Sweet taste ratings (time frame: 6 months). The study lists 2 primary outcomes in all. 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 4 Mar 2024.