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Metabolic Effects of Non-nutritive Sweeteners

NCT ID: NCT02413424

Last Updated: 2017-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Drink Sucralose

Subjects will drink sucralose 10 min before drinking a glucose load

Group Type EXPERIMENTAL

Sucralose

Intervention Type DIETARY_SUPPLEMENT

60 ml of 2mM sucralose

glucose load

Intervention Type DIETARY_SUPPLEMENT

Drink Water

Subjects will drink water 10 min before drinking a glucose load

Group Type PLACEBO_COMPARATOR

Water

Intervention Type OTHER

60 ml of water

glucose load

Intervention Type DIETARY_SUPPLEMENT

Taste and spit Sucralose

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

Group Type EXPERIMENTAL

Sucralose

Intervention Type DIETARY_SUPPLEMENT

60 ml of 2mM sucralose

glucose load

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Sucralose

60 ml of 2mM sucralose

Intervention Type DIETARY_SUPPLEMENT

Water

60 ml of water

Intervention Type OTHER

glucose load

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marta Y Pepino, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Urbana-Champaign

Locations

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University of Illinois at Urbana Champaign

Urbana, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23633524 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20078374 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17724332 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23850261 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25231862 (View on PubMed)

Other Identifiers

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P30DK020579

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201412080

Identifier Type: -

Identifier Source: org_study_id