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CompletedNCT02413424NNSUpdated Sep 21, 2017

Metabolic Effects of Non-nutritive Sweeteners

An interventional study of Sucralose and Water in Obesity, sponsored by University of Illinois at Urbana-Champaign. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-21.

Sponsored by University of Illinois at Urbana-Champaign · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Obesity

Keywords

  • sucralose
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In context

Lead sponsor

University of Illinois at Urbana-Champaign is the lead sponsor of 188 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Drink Sucralose

    Subjects will drink sucralose 10 min before drinking a glucose load

    Dietary Supplement: Sucralose · Dietary Supplement: glucose load

  • Placebo comparator
    Drink Water

    Subjects will drink water 10 min before drinking a glucose load

    Other: Water · Dietary Supplement: glucose load

  • Experimental
    Taste and spit Sucralose

    Subjects will taste and spit up sucralose 10 min before drinking a glucose load

    Dietary Supplement: Sucralose · Dietary Supplement: glucose load

Interventions

  • Dietary supplementSucralose

    60 ml of 2mM sucralose

  • OtherWater

    60 ml of water

  • Dietary supplementglucose load
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 5 hours after drinking a glucose load

  2. 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.

    Time frame: up to 5 hours after drinking a glucose load

Secondary outcomes

  1. Glucose-dependent insulinotropic polypeptide (GIP)

    Blood samples will be collected before and for 5 hours after drinking a glucose load to determine GIP.

    Time frame: up to 5 hours after drinking a glucose load

  2. Sucralose concentrations in plasma

    Sucralose concentrations in plasma will be measured by using liquid chromatography-mass spectrometry.

    Time frame: up to 310 min after drinking the sucralose load

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Study locations

1 site
  • University of Illinois at Urbana Champaign
    Urbana, Illinois 61801, United States
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References and documents

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 23633524 ↗
  • Brown 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 20078374 ↗
  • Margolskee 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 17724332 ↗
  • Swithers 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 23850261 ↗
  • Suez 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02413424
Lead sponsor
University of Illinois at Urbana-Champaign
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Sponsor
First posted
Apr 9, 2015
Start date
Apr 2015
Primary completion
Dec 2016
Completion
Jul 2017
Last update
Sep 21, 2017

Study contacts

Marta Y Pepino, PhD
principal investigator · University of Illinois at Urbana-Champaign

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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