Metabolic Effects of Non-nutritive Sweeteners

Obesity Clinical Trial

— NNS  

Official title:

Metabolic Effects of Non-nutritive Sweeteners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413424
• Other study ID #: 201412080
• Secondary ID: P30DK020579
• Status: Completed
• Phase: N/A
• First received: April 6, 2015
• Last updated: September 19, 2017
• Start date: April 2015
• Est. completion date: July 2017

Study information

• Verified date: September 2017
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Sucralose
60 ml of 2mM sucralose

Other:
• Water
60 ml of water

Dietary Supplement:
• glucose load

Locations

Country	Name	City	State
United States	University of Illinois at Urbana Champaign	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Review. — View Citation

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. Epub 2007 Aug 27. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 5 hours after drinking a glucose load
Primary	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.	up to 5 hours after drinking a glucose load
Secondary	Glucose-dependent insulinotropic polypeptide (GIP)	Blood samples will be collected before and for 5 hours after drinking a glucose load to determine GIP.	up to 5 hours after drinking a glucose load
Secondary	Sucralose concentrations in plasma	Sucralose concentrations in plasma will be measured by using liquid chromatography-mass spectrometry.	up to 310 min after drinking the sucralose load