Metabolic Effects of Non-nutritive Sweeteners

NCT02413424 | Completed DMC

• 2 other identifiers: 201412080P30DK020579
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

sucralose

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Glucose-dependent insulinotropic polypeptide (GIP)

  up to 5 hours after drinking a glucose load

• Sucralose concentrations in plasma

  up to 310 min after drinking the sucralose load

Study Arms (3)

Drink Sucralose

EXPERIMENTAL

Subjects will drink sucralose 10 min before drinking a glucose load

Dietary Supplement: Sucralose; Dietary Supplement: glucose load

Drink Water

PLACEBO COMPARATOR

Subjects will drink water 10 min before drinking a glucose load

Other: Water; Dietary Supplement: glucose load

Taste and spit Sucralose

EXPERIMENTAL

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

Dietary Supplement: Sucralose; Dietary Supplement: glucose load

Interventions

Sucralose DIETARY_SUPPLEMENT

60 ml of 2mM sucralose

Drink Sucralose; Taste and spit Sucralose

Water OTHER

60 ml of water

Drink Water

glucose load DIETARY_SUPPLEMENT

Drink Sucralose; Drink Water; Taste and spit Sucralose

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Illinois at Urbana Champaign

Urbana, Illinois, 61801, United States

Location

Related Publications (5)

• 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.

  PMID: 23633524 BACKGROUND

• 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.

  PMID: 20078374 BACKGROUND

• 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.

  PMID: 17724332 BACKGROUND

• 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.

  PMID: 23850261 BACKGROUND

• 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.

  PMID: 25231862 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

trichlorosucrose; Water

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Marta Y Pepino, PhD

  University of Illinois at Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: April 9, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: July 1, 2017
• Last Updated: September 21, 2017

Record last verified: 2017-09

Locations

US (1)