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Completed

NCT Number: NCT02413424

Metabolic Effects of Non-nutritive Sweeteners

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Urbana Champaign

Urbana, Illinois, 61801, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sucralose

Dietary Supplement

60 ml of 2mM sucralose

Water

Other

60 ml of water

glucose load

Dietary Supplement

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Glucose-dependent insulinotropic polypeptide (GIP)

    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 GIP.

  2. Sucralose concentrations in plasma

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

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

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Collaborators

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

Registry information

Acronym: NNS

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Apr 9, 2015
Registry last updated
Sep 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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