ObesitySTSNCT03844230
Role of Sweetness in Glucose Regulation
A study testing Experimental I- Inhibition, Experimental II- Inhibition and Experimental I- Stimulation in people with Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
Data from several studies show that consuming a diet high in low-calorie sweeteners (LCS), mainly in diet sodas, is linked to the same metabolic disorders as consuming a diet high in added sugars, including an increased risk of developing type 2 diabetes. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Experimental I- Inhibition, Experimental II- Inhibition and Experimental I- Stimulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2019to 31 Dec 2022
- 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 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All races/ethnicities
- Habitual (> 5 diet sodas per week) and non-habitual (≤1 diet soda or 1 packet of LCS per week) LCS consumers
- 30 ≤ BMI <40 kg/m2
- Not severely insulin resistant (HOMA-IR2 < 2.6)
Who cannot join
- BMI < 30 and 40< BMI kg/m2
- HOMA-IR2>2.6
- Irregular LCS consumers (>1 diet sodas or packets of LCS per week but <5)
- Current smokers or quit smoking nicotine cigarettes for less than 6 months ago
- Pregnant, breastfeeding, menopausal
- Presence of anemia : <12g/dl for women and <13g/dl for men
Show all 12Show fewer
- Blood donation in the past 8 weeks
- Presence of malabsorption syndrome
- History of bariatric surgery
- Presence of inflammatory intestinal disease, liver or kidney disease
- Have diabetes (fasting glucose level >126mg/dl or plasma glucose level 2h after glucose challenge >200 mg/dl)
- Taking any medication that might affect glucose metabolism or the results of our study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Urbana Champaign
Champaign, Illinois, 61820
Marta Y Pepino, MSc, RD, 217-300-2374, ypepino@illinois.edu
Clara Salame, MSc, RD, 2178192820, csalame2@illinois.edu
About this study
Official title: Role of Sweet Taste Signaling in Glucose Regulation
Data from several studies show that consuming a diet high in low-calorie sweeteners (LCS), mainly in diet sodas, is linked to the same metabolic disorders as consuming a diet high in added sugars, including an increased risk of developing type 2 diabetes. Sweet taste receptors, once thought to be unique to the mouth, have now been discovered in other parts of the body, including the intestine and the pancreas, where they play a role in blood sugar control. These newly identified receptors provide new avenues to explore how LCS may affect metabolism and health. This project is designed to examine the role of sweet taste signaling, both in the mouth and in the gut, on blood sugar control and how habitual consumption of LCS may affect sweet taste signaling and metabolism in people with obesity.
Read the detailed description
The overall goal of this research is to assess the role of oral and gut sweetness signaling in postprandial glucose metabolism and to determine how acute and chronic low-calorie sweetener (LCS) consumption may affect this signaling in people with obesity. The aims will determine the independent and combined contributions of pharmacological inhibition (Aim 1) or extra stimulation (Aim 2) of sweet taste signaling in the gut, mouth, or both on hormonal responses to an oral glucose tolerance test (OGTT) in two groups of subjects with obesity: habitual and non-habitual LCS consumers. Validated sensory evaluation techniques will also ascertain subjects' taste perception (Aim 3) to test the hypotheses that habitual consumption of LCS blunts perception of sweetness and, in turn, affects postprandial glucose regulation.
- Conditions
- Obesity
- Being tested
- Control - Inhibition, Experimental I- Inhibition, Experimental II- Inhibition, Control- Stimulation, Experimental I- Stimulation
- Keywords
- sweeteners, glucose metabolism, taste receptors, sucralose
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control - InhibitionOther
Taste and spit up water 10 minutes before drinking a glucose load
Experimental I- InhibitionOther
Taste and spit up water 10 minutes before drinking a glucose load mixed with lactisole
Experimental II- InhibitionOther
Taste and spit up sucralose 10 minutes before drinking a glucose load mixed with lactisole
Control- StimulationOther
Taste and spit up water 10 minutes before drinking a glucose load
Experimental I- StimulationOther
Taste and spit up sucralose 10 minutes before drinking a glucose load
Experimental II- StimulationOther
Drink sucralose 10 minutes before drinking a glucose load
Sensory EvaluationOther
Taste different solutions to evaluate sweet taste preference, suprathreshold intensity and detection threshold
| Study group | Role | What they receive |
|---|---|---|
| Inhibition Group | Other | Randomly selected habitual and non habitual LCS consumers will be assessed on three different oral glucose tolerance test conditions (i.e. Control - Inhibition, Experimental I- Inhibition, Experimental II- Inhibition). A separate visit will evaluate their sweet taste perception and preferences (Sensory evaluation). Receives: Other: Control - Inhibition; Other: Experimental I- Inhibition; Other: Experimental II- Inhibition; Other: Sensory Evaluation |
| Stimulation Group | Other | Randomly selected habitual and non habitual LCS consumers will be assessed on three different oral glucose tolerance test conditions (i.e. Control - Stimulation, Experimental I- Stimulation, Experimental II -Stimulation). A separate visit will evaluate their sweet taste perception and preferences (Sensory evaluation). Receives: Other: Control- Stimulation; Other: Experimental I- Stimulation; Other: Experimental II- Stimulation; Other: Sensory Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Glucose
Blood samples will be collected before and for 5 hours after drinking a glucose load to determine plasma glucose concentration
Measured: Up to 5 hours after drinking a glucose load
Plasma Insulin
Blood samples will be collected before and for 5 hours after drinking a glucose load to determine plasma insulin concentration
Measured: Up to 5 hours after drinking a glucose load
Plasma C-Peptide
Blood samples will be collected before and for 5 hours after drinking a glucose load to determine plasma C-peptide concentration
Measured: Up to 5 hours after drinking a glucose load
Sensory Evaluation
Participants will be tasting solutions containing different concentrations of glucose, sucrose and sucralose (some of the solutions will also have lactisole) to assess their detection threshold, sweet taste intensity and preference. They will have to rate the intensity of the solution on a general Labeled Magnitude Scale (gLMS) ranging from "no sensation" (0) to "strongest imaginable sensation" (100) and choose the solutions they prefer.
Measured: Up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start24 Apr 2019
- Primary completion30 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Marta Y Pepino, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844230
- Sponsor's protocol ID
- 19294
- Acronym
- STS
- Status last verified
- Apr 2021
- First submitted
- 29 Jan 2019
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Consistent with the need to not compromise human subject protections, raw data that identifies participants will not be shared with anyone not included on our IRB approval. De-identified data, from participants who consented to share their de-identified data will be deposit in a data repository (e.g. Figshare).
Publications
Adams TB, Cohen SM, Doull J, Feron VJ, Goodman JI, Marnett LJ, Munro IC, Portoghese PS, Smith RL, Waddell WJ, Wagner BM; Expert Panel of the Flavor and Extract Manufacturers Association. The FEMA GRAS assessment of phenethyl alcohol, aldehyde, acid, and related acetals and esters used as flavor ingredients. Food Chem Toxicol. 2005 Aug;43(8):1179-206. doi: 10.1016/j.fct.2004.11.013. Epub 2005 Jan 26.
PubMed 15950814Schiffman SS, Booth BJ, Sattely-Miller EA, Graham BG, Gibes KM. Selective inhibition of sweetness by the sodium salt of +/-2-(4-methoxyphenoxy)propanoic acid. Chem Senses. 1999 Aug;24(4):439-47. doi: 10.1093/chemse/24.4.439.
PubMed 10480680Jiang P, Cui M, Zhao B, Liu Z, Snyder LA, Benard LM, Osman R, Margolskee RF, Max M. Lactisole interacts with the transmembrane domains of human T1R3 to inhibit sweet taste. J Biol Chem. 2005 Apr 15;280(15):15238-46. doi: 10.1074/jbc.M414287200. Epub 2005 Jan 24.
PubMed 15668251Karimian Azari E, Smith KR, Yi F, Osborne TF, Bizzotto R, Mari A, Pratley RE, Kyriazis GA. Inhibition of sweet chemosensory receptors alters insulin responses during glucose ingestion in healthy adults: a randomized crossover interventional study. Am J Clin Nutr. 2017 Apr;105(4):1001-1009. doi: 10.3945/ajcn.116.146001. Epub 2017 Mar 1.
PubMed 28251932Pepino MY, Tiemann CD, Patterson BW, Wice BM, Klein S. Sucralose affects glycemic and hormonal responses to an oral glucose load. Diabetes Care. 2013 Sep;36(9):2530-5. doi: 10.2337/dc12-2221. Epub 2013 Apr 30.
PubMed 23633524Steinert 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 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Sweet Taste Signaling in Glucose Regulation
- ClinicalTrials.gov ID
- NCT03844230
- Acronym / sponsor ID
- STS / 19294
- Conditions
- Obesity
- Keywords
- sweeteners, glucose metabolism, taste receptors, sucralose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Feb 2019 (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.
Data from several studies show that consuming a diet high in low-calorie sweeteners (LCS), mainly in diet sodas, is linked to the same metabolic disorders as consuming a diet high in added sugars, including an increased risk of developing type 2 diabetes. Sweet taste receptors, once thought to be unique to the mouth, have now been discovered in other parts of the body, including the intestine and the pancreas, where they play a role in blood sugar control. These newly identified receptors provide new avenues to explore how LCS may affect metabolism and health. This project is designed to examine the role of sweet taste signaling, both in the mouth and in the gut, on blood sugar control and how habitual consumption of LCS may affect sweet taste signaling and metabolism in people with obesity.
Detailed description
The overall goal of this research is to assess the role of oral and gut sweetness signaling in postprandial glucose metabolism and to determine how acute and chronic low-calorie sweetener (LCS) consumption may affect this signaling in people with obesity. The aims will determine the independent and combined contributions of pharmacological inhibition (Aim 1) or extra stimulation (Aim 2) of sweet taste signaling in the gut, mouth, or both on hormonal responses to an oral glucose tolerance test (OGTT) in two groups of subjects with obesity: habitual and non-habitual LCS consumers. Validated sensory evaluation techniques will also ascertain subjects' taste perception (Aim 3) to test the hypotheses that habitual consumption of LCS blunts perception of sweetness and, in turn, affects postprandial glucose regulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhibition Group | Other | Other: Control - Inhibition, Other: Experimental I- Inhibition, Other: Experimental II- Inhibition, Other: Sensory EvaluationRandomly selected habitual and non habitual LCS consumers will be assessed on three different oral glucose tolerance test conditions (i.e. Control - Inhibition, Experimental I- Inhibition, Experimental II- Inhibition). A separate visit will evaluate their sweet taste perception and preferences (Sensory evaluation). |
| Stimulation Group | Other | Other: Control- Stimulation, Other: Experimental I- Stimulation, Other: Experimental II- Stimulation, Other: Sensory EvaluationRandomly selected habitual and non habitual LCS consumers will be assessed on three different oral glucose tolerance test conditions (i.e. Control - Stimulation, Experimental I- Stimulation, Experimental II -Stimulation). A separate visit will evaluate their sweet taste perception and preferences (Sensory evaluation). |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All races/ethnicities
- Habitual (> 5 diet sodas per week) and non-habitual (≤1 diet soda or 1 packet of LCS per week) LCS consumers
- 30 ≤ BMI <40 kg/m2
- Not severely insulin resistant (HOMA-IR2 < 2.6)
Key exclusion criteria (12 listed)
- BMI < 30 and 40< BMI kg/m2
- HOMA-IR2>2.6
- Irregular LCS consumers (>1 diet sodas or packets of LCS per week but <5)
- Current smokers or quit smoking nicotine cigarettes for less than 6 months ago
- Pregnant, breastfeeding, menopausal
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 |
|---|---|---|
| Control - InhibitionTaste and spit up water 10 minutes before drinking a glucose load | Other | Inhibition Group |
| Experimental I- InhibitionTaste and spit up water 10 minutes before drinking a glucose load mixed with lactisole | Other | Inhibition Group |
| Experimental II- InhibitionTaste and spit up sucralose 10 minutes before drinking a glucose load mixed with lactisole | Other | Inhibition Group |
| Control- StimulationTaste and spit up water 10 minutes before drinking a glucose load | Other | Stimulation Group |
| Experimental I- StimulationTaste and spit up sucralose 10 minutes before drinking a glucose load | Other | Stimulation Group |
| Experimental II- StimulationDrink sucralose 10 minutes before drinking a glucose load | Other | Stimulation Group |
| Sensory EvaluationTaste different solutions to evaluate sweet taste preference, suprathreshold intensity and detection threshold | Other | Inhibition Group, Stimulation Group |
Primary outcome
Plasma Glucose
Time frame: Up to 5 hours after drinking a glucose load
Blood samples will be collected before and for 5 hours after drinking a glucose load to determine plasma glucose concentration
Plasma Insulin
Time frame: Up to 5 hours after drinking a glucose load
Blood samples will be collected before and for 5 hours after drinking a glucose load to determine plasma insulin concentration
Plasma C-Peptide
Time frame: Up to 5 hours after drinking a glucose load
Blood samples will be collected before and for 5 hours after drinking a glucose load to determine plasma C-peptide concentration
Sensory Evaluation
Time frame: Up to 2 hours
Participants will be tasting solutions containing different concentrations of glucose, sucrose and sucralose (some of the solutions will also have lactisole) to assess their detection threshold, sweet taste intensity and preference. They will have to rate the intensity of the solution on a general Labeled Magnitude Scale (gLMS) ranging from "no sensation" (0) to "strongest imaginable sensation" (100) and choose the solutions they prefer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Background: PubMed 15950814Adams TB, Cohen SM, Doull J, Feron VJ, Goodman JI, Marnett LJ, Munro IC, Portoghese PS, Smith RL, Waddell WJ, Wagner BM; Expert Panel of the Flavor and Extract Manufacturers Association. The FEMA GRAS assessment of phenethyl alcohol, aldehyde, acid, and related acetals and esters used as flavor ingredients. Food Chem Toxicol. 2005 Aug;43(8):1179-206. doi: 10.1016/j.fct.2004.11.013. Epub 2005 Jan 26.
- Background: PubMed 10480680Schiffman SS, Booth BJ, Sattely-Miller EA, Graham BG, Gibes KM. Selective inhibition of sweetness by the sodium salt of +/-2-(4-methoxyphenoxy)propanoic acid. Chem Senses. 1999 Aug;24(4):439-47. doi: 10.1093/chemse/24.4.439.
- Background: PubMed 15668251Jiang P, Cui M, Zhao B, Liu Z, Snyder LA, Benard LM, Osman R, Margolskee RF, Max M. Lactisole interacts with the transmembrane domains of human T1R3 to inhibit sweet taste. J Biol Chem. 2005 Apr 15;280(15):15238-46. doi: 10.1074/jbc.M414287200. Epub 2005 Jan 24.
- Background: PubMed 28251932Karimian Azari E, Smith KR, Yi F, Osborne TF, Bizzotto R, Mari A, Pratley RE, Kyriazis GA. Inhibition of sweet chemosensory receptors alters insulin responses during glucose ingestion in healthy adults: a randomized crossover interventional study. Am J Clin Nutr. 2017 Apr;105(4):1001-1009. doi: 10.3945/ajcn.116.146001. Epub 2017 Mar 1.
- Background: PubMed 23633524Pepino MY, Tiemann CD, Patterson BW, Wice BM, Klein S. Sucralose affects glycemic and hormonal responses to an oral glucose load. Diabetes Care. 2013 Sep;36(9):2530-5. doi: 10.2337/dc12-2221. Epub 2013 Apr 30.
- Background: 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.
- Individual participant dataSharing planned: Yes. Consistent with the need to not compromise human subject protections, raw data that identifies participants will not be shared with anyone not included on our IRB approval. De-identified data, from participants who consented to share their de-identified data will be deposit in a data repository (e.g. Figshare).
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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.
Marta Y Pepino, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental I- Inhibition, Experimental II- Inhibition and Experimental I- Stimulation in people with Obesity, run by University of Illinois at Urbana-Champaign 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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 27 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta Y Pepino, PhD ((217) 300-2374, ypepino@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Glucose (time frame: Up to 5 hours after drinking a glucose load). The study lists 4 primary outcomes in all. 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 NCT03844230, which also lists 6 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 27 Apr 2021.