Neat OGTTSLOGTTNCT05900193
Sucralose and Lactisole Additions to OGTT in Humans
A study testing TAS1R2/3 agonist or antagoinst admixture to oral glucose tolerance test in people with Neat OGTT and OGTT With Added Sucralose, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
In the present study, our objective was to determine whether T1R2-T1R3 influences glucose metabolism bidirectionally via hyperactivation with sucralose and inhibition with sodium lactisole in mixture with glucose loads during tolerance tests in humans. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Neat OGTT, OGTT With Added Sucralose, OGTT With Added Lactisole
- What is being tested?
- TAS1R2/3 agonist or antagoinst admixture to oral glucose tolerance test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2016to Oct 2017
- 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
- Non-diabetic
- No metabolic disease
- Should not have exercised in past 24 hours.
- Should have undergone overnight fast.
- BMI <30 kg/m2
Who cannot join
- Participants who reported consuming more than one serving of artificially sweetened beverages or snacks per day were excluded.
- Participants with diseases (e.g. metabolic syndrome and diabetes) and medications that may affect taste, digestion and absorption (e.g. anti-hypertensives, antibiotics, insulin, metformin, SGLT2 Inhibitors, sulfonylureas) were also excluded.
- Participants with BMI>30 kg/m2 were excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers, Department of Nutritional Sciences
New Brunswick, New Jersey, 08901
About this study
Official title: Activation and Inhibition of the Sweet Taste Receptor T1R2-T1R3 Differentially Affect Glucose Tolerance in Humans
In the present study, our objective was to determine whether T1R2-T1R3 influences glucose metabolism bidirectionally via hyperactivation with sucralose and inhibition with sodium lactisole in mixture with glucose loads during tolerance tests in humans. In 12 healthy participants we conducted oral glucose tolerance tests (OGTTs) of 75 g glucose with and without the addition of the T1R2-T1R3 agonist, sucralose (5 mM). We also conducted OGTTs in 10 healthy participants with and without the addition of a T1R2-T1R3 antagonist, sodium lactisole (2 mM). Plasma glucose, insulin, and glucagon were measured before, during, and after OGTTs up to 120 minutes post-prandially. We also assessed individual participants' sweet taste responses to sucralose, their sensitivities to sweetness inhibition by lactisole, and their BMIs.
Read the detailed description
The sweet taste receptor, T1R2-T1R3, is expressed in taste bud cells, where it conveys sweetness, and also in intestinal enteroendocrine cells, where it may facilitate glucose absorption and assimilation. There is evidence in mice through genetic knockout studies that T1r2-T1r3 is involved in endocrine and enteroendocrine responses to glucose loads. Yet, our understanding of the impact of T1R2-T1R3 on human glucose metabolism is less clear. In the present study, our objective was to determine whether T1R2-T1R3 influences glucose metabolism bidirectionally via hyperactivation with sucralose and inhibition with sodium lactisole in mixture with glucose loads during tolerance tests in humans. In 12 healthy participants we conducted oral glucose tolerance tests (OGTTs) of 75 g glucose with and without the addition of the T1R2-T1R3 agonist, sucralose (5 mM). We also conducted OGTTs in 10 healthy participants with and without the addition of a T1R2-T1R3 antagonist, sodium lactisole (2 mM). Plasma glucose, insulin, and glucagon were measured before, during, and after OGTTs up to 120 minutes post-prandially. We also assessed individual participants' sweet taste responses to sucralose, their sensitivities to sweetness inhibition by lactisole, and their BMIs. The addition of sucralose to glucose elevated plasma insulin responses to the OGTT. Sucralose-sensitive participants, those who rated sucralose as sweetest, had a more pronounced elevation in peak plasma insulin to sucralose + glucose with early increases in plasma glucose and insulin area-under-the-curve (AUC) within the first 15 minutes. In lactisole-sensitive participants, whose sweetness was suppressed by low levels of lactisole, the addition of lactisole to glucose in the OGTT decreased plasma glucose AUC. Participants with higher BMI (>24 kg/m2) tended to be hyper-responsive to added sucralose, nearly doubling their peak levels of insulin to the sucralose + glucose OGTT . Manipulation of the T1R2-T1R3 receptor with a non-caloric agonist and an antagonist demonstrates that T1R2-T1R3 helps regulate glucose handling and metabolism in humans. Importantly, participants with BMI > 24 kg/m2 tended to rate sucralose as sweeter and showed exaggerated insulin increases when it was added to their OGTT.
- Being tested
- TAS1R2/3 agonist or antagoinst admixture to oral glucose tolerance test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS1R2/3 agonist or antagoinst admixture to oral glucose tolerance testDietary supplement
Participants drank a glucose beverage for an oral glucose tolerance test along or with admixture with the TAS1R2/3 agonist sucralose or the TAS1R2/3 antagonist lactisole.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving oral glucose tolerane tests with TAS1R agonists | Experimental | Participants received a standard oral glucose tolerance test alone and with the addition of the TAS1R2/3 agonist sucralose in admixture Receives: Dietary Supplement: TAS1R2/3 agonist or antagoinst admixture to oral glucose tolerance test |
| Participants receiving oral glucose tolerane tests with TAS1R antagonists | Experimental | Participants received a standard oral glucose tolerance test alone and with the addition of the the TAS1R2/3 antagonist lactisole in admixture Receives: Dietary Supplement: TAS1R2/3 agonist or antagoinst admixture to oral glucose tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Glucose
Repeated plasma blood draws during OGTT will determine plasma glucose
Measured: 90 minutes
Plasma Insulin
Repeated plasma blood draws during OGTT will determine plasma insulin
Measured: 90 minutes
Plasma glucagon
Repeated plasma blood draws during OGTT will determine plasma glucagon
Measured: 90 minutes
Secondary outcomes (3)
Taste responsivity to sucralose
How sweet sucralose tastes to participants is reported
Measured: 30 minutes
Taste inhibition by lactisole
How effectively lactisole inhibits sweet taste for individual participants is assessed
Measured: 30 minutes
Body-mass Index
Individual participant BMI was calculated
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start17 Jul 2016
- Primary completion18 Sep 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neat OGTTStudies 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
- Sequential
- Model description
- Participants were given oral glucose tolerance tests alone or with lactisole or sucralose in admixture with the glucose. All controls were within subjects in counterbalanced crossover design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Breslin, PhD, Rutgers, The State University of New Jersey
- Investigators
- Paul Breslin, PhD, Principal investigator, Rutgers, The State University of NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900193
- Sponsor's protocol ID
- 16-105mc
- Acronym
- SLOGTT
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Journals require de-identified data be made available to others.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activation and Inhibition of the Sweet Taste Receptor T1R2-T1R3 Differentially Affect Glucose Tolerance in Humans
- ClinicalTrials.gov ID
- NCT05900193
- Acronym / sponsor ID
- SLOGTT / 16-105mc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 17 Jul 2016 (actual)
- Primary completion
- 18 Sep 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 12 Jun 2023 (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.
In the present study, our objective was to determine whether T1R2-T1R3 influences glucose metabolism bidirectionally via hyperactivation with sucralose and inhibition with sodium lactisole in mixture with glucose loads during tolerance tests in humans. In 12 healthy participants we conducted oral glucose tolerance tests (OGTTs) of 75 g glucose with and without the addition of the T1R2-T1R3 agonist, sucralose (5 mM). We also conducted OGTTs in 10 healthy participants with and without the addition of a T1R2-T1R3 antagonist, sodium lactisole (2 mM). Plasma glucose, insulin, and glucagon were measured before, during, and after OGTTs up to 120 minutes post-prandially. We also assessed individual participants' sweet taste responses to sucralose, their sensitivities to sweetness inhibition by lactisole, and their BMIs.
Detailed description
The sweet taste receptor, T1R2-T1R3, is expressed in taste bud cells, where it conveys sweetness, and also in intestinal enteroendocrine cells, where it may facilitate glucose absorption and assimilation. There is evidence in mice through genetic knockout studies that T1r2-T1r3 is involved in endocrine and enteroendocrine responses to glucose loads. Yet, our understanding of the impact of T1R2-T1R3 on human glucose metabolism is less clear. In the present study, our objective was to determine whether T1R2-T1R3 influences glucose metabolism bidirectionally via hyperactivation with sucralose and inhibition with sodium lactisole in mixture with glucose loads during tolerance tests in humans. In 12 healthy participants we conducted oral glucose tolerance tests (OGTTs) of 75 g glucose with and without the addition of the T1R2-T1R3 agonist, sucralose (5 mM). We also conducted OGTTs in 10 healthy participants with and without the addition of a T1R2-T1R3 antagonist, sodium lactisole (2 mM). Plasma glucose, insulin, and glucagon were measured before, during, and after OGTTs up to 120 minutes post-prandially. We also assessed individual participants' sweet taste responses to sucralose, their sensitivities to sweetness inhibition by lactisole, and their BMIs. The addition of sucralose to glucose elevated plasma insulin responses to the OGTT. Sucralose-sensitive participants, those who rated sucralose as sweetest, had a more pronounced elevation in peak plasma insulin to sucralose + glucose with early increases in plasma glucose and insulin area-under-the-curve (AUC) within the first 15 minutes. In lactisole-sensitive participants, whose sweetness was suppressed by low levels of lactisole, the addition of lactisole to glucose in the OGTT decreased plasma glucose AUC. Participants with higher BMI (>24 kg/m2) tended to be hyper-responsive to added sucralose, nearly doubling their peak levels of insulin to the sucralose + glucose OGTT . Manipulation of the T1R2-T1R3 receptor with a non-caloric agonist and an antagonist demonstrates that T1R2-T1R3 helps regulate glucose handling and metabolism in humans. Importantly, participants with BMI > 24 kg/m2 tended to rate sucralose as sweeter and showed exaggerated insulin increases when it was added to their OGTT.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were given oral glucose tolerance tests alone or with lactisole or sucralose in admixture with the glucose. All controls were within subjects in counterbalanced crossover design.
| Arm | Type | Receives |
|---|---|---|
| Participants receiving oral glucose tolerane tests with TAS1R agonists | Experimental | Dietary Supplement: TAS1R2/3 agonist or antagoinst admixture to oral glucose tolerance testParticipants received a standard oral glucose tolerance test alone and with the addition of the TAS1R2/3 agonist sucralose in admixture |
| Participants receiving oral glucose tolerane tests with TAS1R antagonists | Experimental | Dietary Supplement: TAS1R2/3 agonist or antagoinst admixture to oral glucose tolerance testParticipants received a standard oral glucose tolerance test alone and with the addition of the the TAS1R2/3 antagonist lactisole in admixture |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-diabetic
- No metabolic disease
- Should not have exercised in past 24 hours.
- Should have undergone overnight fast.
- BMI <30 kg/m2
Key exclusion criteria (3 listed)
- Participants who reported consuming more than one serving of artificially sweetened beverages or snacks per day were excluded.
- Participants with diseases (e.g. metabolic syndrome and diabetes) and medications that may affect taste, digestion and absorption (e.g. anti-hypertensives, antibiotics, insulin, metformin, SGLT2 Inhibitors, sulfonylureas) were also excluded.
- Participants with BMI>30 kg/m2 were excluded.
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 |
|---|---|---|
| TAS1R2/3 agonist or antagoinst admixture to oral glucose tolerance testParticipants drank a glucose beverage for an oral glucose tolerance test along or with admixture with the TAS1R2/3 agonist sucralose or the TAS1R2/3 antagonist lactisole. | Dietary supplement | Participants receiving oral glucose tolerane tests with TAS1R agonists, Participants receiving oral glucose tolerane tests with TAS1R antagonists |
Primary outcome
Plasma Glucose
Time frame: 90 minutes
Repeated plasma blood draws during OGTT will determine plasma glucose
Plasma Insulin
Time frame: 90 minutes
Repeated plasma blood draws during OGTT will determine plasma insulin
Plasma glucagon
Time frame: 90 minutes
Repeated plasma blood draws during OGTT will determine plasma glucagon
3 secondary outcomes
Taste responsivity to sucralose
Time frame: 30 minutes
Taste inhibition by lactisole
Time frame: 30 minutes
Body-mass Index
Time frame: 15 minutes
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 12 Jun 2023.
- Individual participant dataSharing planned: Yes. Journals require de-identified data be made available to others.
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 Breslin, PhD principal investigator
Rutgers, The State University of NJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAS1R2/3 agonist or antagoinst admixture to oral glucose tolerance test in people with Neat OGTT and OGTT With Added Sucralose, 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 5 inclusion and 3 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 12 Jun 2023. 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?
Plasma Glucose (time frame: 90 minutes). The study lists 3 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 12 Jun 2023.