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Metabolic Effects of Non-nutritive Sweeteners (NNS)

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ClinicalTrials.gov Identifier: NCT02413424
Recruitment Status : Completed
First Posted : April 9, 2015
Last Update Posted : September 21, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Illinois at Urbana-Champaign

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Sucralose Other: Water Dietary Supplement: glucose load Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Metabolic Effects of Non-nutritive Sweeteners
Study Start Date : April 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : July 2017

Arm Intervention/treatment
Experimental: Drink Sucralose
Subjects will drink sucralose 10 min before drinking a glucose load
Dietary Supplement: Sucralose
60 ml of 2mM sucralose

Dietary Supplement: glucose load
Placebo Comparator: Drink Water
Subjects will drink water 10 min before drinking a glucose load
Other: Water
60 ml of 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
60 ml of 2mM sucralose

Dietary Supplement: glucose load



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413424


Locations
United States, Illinois
University of Illinois at Urbana Champaign
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Marta Y Pepino, PhD University of Illinois at Urbana-Champaign

Publications:
Responsible Party: University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT02413424     History of Changes
Other Study ID Numbers: 201412080
P30DK020579 ( U.S. NIH Grant/Contract )
First Posted: April 9, 2015    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017

Keywords provided by University of Illinois at Urbana-Champaign:
sucralose