ObesityNNSNCT02413424
Metabolic Effects of Non-nutritive Sweeteners
A study testing Sucralose, Water and glucose load in people with Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The purpose of this research study is to examine whether sugar-replacement sweeteners that are currently on the market (ex. Sucralose, which is in Splenda) change how well the body works to control blood sugar. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Sucralose, Water and glucose load
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jul 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI ≥ 30 kg/m2 or BMI ≥ 18 kg/m2 and BMI<25 kg/m2
- "insulin sensitive": based on the homeostasis model assessment of insulin resistance (HOMA-IR) <3
Who cannot join
- BMI ≥ 25 kg/m2 and BMI<30 kg/m2
- HOMA-IR>3
- Current smoker or quit smoking less than 6 months ago
- pregnancy or breastfeeding
- subjects who have malabsorptive syndromes, phenylketonuria, inflammatory intestinal disease, liver or kidney diseases, diabetes
- subjects who are taking any medication that might affect metabolism
- anemia
- regular use of non-nutritive sweeteners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana Champaign
Urbana, Illinois, 61801
About this study
The purpose of this research study is to examine whether sugar-replacement sweeteners that are currently on the market (ex. Sucralose, which is in Splenda) change how well the body works to control blood sugar.
Read the detailed description
The investigators of this study have recently found that sucralose, the most commonly used non-nutritive sweetener (NNS), affects the glycemic response to an oral glucose tolerance test (OGTT) and potentiates glucose-stimulated insulin secretion in obese people who are not regular consumers of NNS. However, studies conducted in healthy lean adults, none of which control for previous use of NNS, show that sucralose does not affect glycemic or hormonal responses to the ingestion of glucose or other carbohydrates. Therefore, we do not know a) whether sucralose effects are limited to obese subjects, or are generalizable to lean people when controlling for prior history of NNS consumption, and b) mechanism(s) responsible for the acute effect of sucralose on glucose metabolism as we measured in obese subjects. The aim of this study is to determine the effects of an acute intake of sucralose on the metabolic response to an oral glucose tolerance test in lean and obese people.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucraloseDietary supplement
60 ml of 2mM sucralose
WaterOther
60 ml of water
glucose loadDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Drink Sucralose | Experimental | Subjects will drink sucralose 10 min before drinking a glucose load Receives: Dietary Supplement: Sucralose; Dietary Supplement: glucose load |
| Drink Water | Placebo comparator | Subjects will drink water 10 min before drinking a glucose load Receives: Other: Water; Dietary Supplement: glucose load |
| Taste and spit Sucralose | Experimental | Subjects will taste and spit up sucralose 10 min before drinking a glucose load Receives: Dietary Supplement: Sucralose; Dietary Supplement: glucose load |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak insulin secretion rate
Blood samples will be collected before and for 5 hours after drinking a glucose load to determine plasma insulin and C-peptide. Insulin secretion rate will be assessed using the minimal model of Breda and collaborators.
Measured: up to 5 hours after drinking a glucose load
Glucose rate of appearance
Blood samples will be collected before and for 5 hours after drinking a glucose load to determine glucose and glucose tracer:tracee ratios.
Measured: up to 5 hours after drinking a glucose load
Secondary outcomes (2)
Glucose-dependent insulinotropic polypeptide (GIP)
Blood samples will be collected before and for 5 hours after drinking a glucose load to determine GIP.
Measured: up to 5 hours after drinking a glucose load
Sucralose concentrations in plasma
Sucralose concentrations in plasma will be measured by using liquid chromatography-mass spectrometry.
Measured: up to 310 min after drinking the sucralose load
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Y Pepino, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413424
- Sponsor's protocol ID
- 201412080
- Other IDs
- P30DK020579
- Acronym
- NNS
- Status last verified
- Sep 2017
- First submitted
- 6 Apr 2015
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pepino 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 23633524Brown RJ, de Banate MA, Rother KI. Artificial sweeteners: a systematic review of metabolic effects in youth. Int J Pediatr Obes. 2010 Aug;5(4):305-12. doi: 10.3109/17477160903497027.
PubMed 20078374Margolskee RF, Dyer J, Kokrashvili Z, Salmon KS, Ilegems E, Daly K, Maillet EL, Ninomiya Y, Mosinger B, Shirazi-Beechey SP. T1R3 and gustducin in gut sense sugars to regulate expression of Na+-glucose cotransporter 1. Proc Natl Acad Sci U S A. 2007 Sep 18;104(38):15075-80. doi: 10.1073/pnas.0706678104. Epub 2007 Aug 27.
PubMed 17724332Swithers SE. Artificial sweeteners produce the counterintuitive effect of inducing metabolic derangements. Trends Endocrinol Metab. 2013 Sep;24(9):431-41. doi: 10.1016/j.tem.2013.05.005. Epub 2013 Jul 10.
PubMed 23850261Suez J, Korem T, Zeevi D, Zilberman-Schapira G, Thaiss CA, Maza O, Israeli D, Zmora N, Gilad S, Weinberger A, Kuperman Y, Harmelin A, Kolodkin-Gal I, Shapiro H, Halpern Z, Segal E, Elinav E. Artificial sweeteners induce glucose intolerance by altering the gut microbiota. Nature. 2014 Oct 9;514(7521):181-6. doi: 10.1038/nature13793. Epub 2014 Sep 17.
PubMed 25231862
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Non-nutritive Sweeteners
- ClinicalTrials.gov ID
- NCT02413424
- Acronym / sponsor ID
- NNS / 201412080
- Conditions
- Obesity
- Keywords
- sucralose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Apr 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 9 Apr 2015 (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 research study is to examine whether sugar-replacement sweeteners that are currently on the market (ex. Sucralose, which is in Splenda) change how well the body works to control blood sugar.
Detailed description
The investigators of this study have recently found that sucralose, the most commonly used non-nutritive sweetener (NNS), affects the glycemic response to an oral glucose tolerance test (OGTT) and potentiates glucose-stimulated insulin secretion in obese people who are not regular consumers of NNS. However, studies conducted in healthy lean adults, none of which control for previous use of NNS, show that sucralose does not affect glycemic or hormonal responses to the ingestion of glucose or other carbohydrates. Therefore, we do not know a) whether sucralose effects are limited to obese subjects, or are generalizable to lean people when controlling for prior history of NNS consumption, and b) mechanism(s) responsible for the acute effect of sucralose on glucose metabolism as we measured in obese subjects. The aim of this study is to determine the effects of an acute intake of sucralose on the metabolic response to an oral glucose tolerance test in lean and obese people.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Drink Sucralose | Experimental | Dietary Supplement: Sucralose, Dietary Supplement: glucose loadSubjects will drink sucralose 10 min before drinking a glucose load |
| Drink Water | Placebo comparator | Other: Water, Dietary Supplement: glucose loadSubjects will drink water 10 min before drinking a glucose load |
| Taste and spit Sucralose | Experimental | Dietary Supplement: Sucralose, Dietary Supplement: glucose loadSubjects will taste and spit up sucralose 10 min before drinking a glucose load |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI ≥ 30 kg/m2 or BMI ≥ 18 kg/m2 and BMI<25 kg/m2
- "insulin sensitive": based on the homeostasis model assessment of insulin resistance (HOMA-IR) <3
Key exclusion criteria (8 listed)
- BMI ≥ 25 kg/m2 and BMI<30 kg/m2
- HOMA-IR>3
- Current smoker or quit smoking less than 6 months ago
- pregnancy or breastfeeding
- subjects who have malabsorptive syndromes, phenylketonuria, inflammatory intestinal disease, liver or kidney diseases, diabetes
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 |
|---|---|---|
| Sucralose60 ml of 2mM sucralose | Dietary supplement | Drink Sucralose, Taste and spit Sucralose |
| Water60 ml of water | Other | Drink Water |
| glucose load | Dietary supplement | Drink Sucralose, Drink Water, Taste and spit Sucralose |
Primary outcome
Peak insulin secretion rate
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 and C-peptide. Insulin secretion rate will be assessed using the minimal model of Breda and collaborators.
Glucose rate of appearance
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 glucose and glucose tracer:tracee ratios.
2 secondary outcomes
Glucose-dependent insulinotropic polypeptide (GIP)
Time frame: up to 5 hours after drinking a glucose load
Sucralose concentrations in plasma
Time frame: up to 310 min after drinking the sucralose load
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 21 Sep 2017.
- 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 20078374Brown RJ, de Banate MA, Rother KI. Artificial sweeteners: a systematic review of metabolic effects in youth. Int J Pediatr Obes. 2010 Aug;5(4):305-12. doi: 10.3109/17477160903497027.
- Background: PubMed 17724332Margolskee RF, Dyer J, Kokrashvili Z, Salmon KS, Ilegems E, Daly K, Maillet EL, Ninomiya Y, Mosinger B, Shirazi-Beechey SP. T1R3 and gustducin in gut sense sugars to regulate expression of Na+-glucose cotransporter 1. Proc Natl Acad Sci U S A. 2007 Sep 18;104(38):15075-80. doi: 10.1073/pnas.0706678104. Epub 2007 Aug 27.
- Background: PubMed 23850261Swithers SE. Artificial sweeteners produce the counterintuitive effect of inducing metabolic derangements. Trends Endocrinol Metab. 2013 Sep;24(9):431-41. doi: 10.1016/j.tem.2013.05.005. Epub 2013 Jul 10.
- Background: PubMed 25231862Suez J, Korem T, Zeevi D, Zilberman-Schapira G, Thaiss CA, Maza O, Israeli D, Zmora N, Gilad S, Weinberger A, Kuperman Y, Harmelin A, Kolodkin-Gal I, Shapiro H, Halpern Z, Segal E, Elinav E. Artificial sweeteners induce glucose intolerance by altering the gut microbiota. Nature. 2014 Oct 9;514(7521):181-6. doi: 10.1038/nature13793. Epub 2014 Sep 17.
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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 Sucralose, Water and glucose load 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 2 inclusion and 8 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 21 Sep 2017. 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. 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.
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?
Peak insulin secretion rate (time frame: up to 5 hours after drinking a glucose load). 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?
On the ClinicalTrials.gov record for NCT02413424, which also lists 5 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 21 Sep 2017.