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Metabolic Effects of Non-nutritive Sweeteners (NNS)

U

University of Illinois at Urbana-Champaign

Status

Completed

Conditions

Obesity

Treatments

Dietary Supplement: glucose load
Other: Water
Dietary Supplement: Sucralose

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02413424
201412080
P30DK020579 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

38 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

38 participants in 3 patient groups, including a placebo group

Drink Sucralose
Experimental group
Description:
Subjects will drink sucralose 10 min before drinking a glucose load
Treatment:
Dietary Supplement: Sucralose
Dietary Supplement: glucose load
Drink Water
Placebo Comparator group
Description:
Subjects will drink water 10 min before drinking a glucose load
Treatment:
Dietary Supplement: glucose load
Other: Water
Taste and spit Sucralose
Experimental group
Description:
Subjects will taste and spit up sucralose 10 min before drinking a glucose load
Treatment:
Dietary Supplement: Sucralose
Dietary Supplement: glucose load

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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