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Sugar-replacement Sweeteners, and Blood Sugar Control (SIR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marta Yanina Pepino de Gruev, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01128829
First received: May 20, 2010
Last updated: December 15, 2014
Last verified: December 2014

May 20, 2010
December 15, 2014
May 2010
February 2012   (final data collection date for primary outcome measure)
The Effect of Sucralose on Insulin Concentration (Area Under the Curve; AUC) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
we will measure plasma insulin concentrations during a 5-hour modified Oral Glucose Tolerance Test (mOGTT) administered 10 minutes after subjects consume sucralose in water or an equal volume of water without sucralose (control condition).Plasma insulin concentrations were measured at 20, 15, 10, 6, and 2 min before and at 10, 20, 30, 40, 60, 90, 120, 150,180, 240, and 300 min after ingesting 75g of glucose. All these data collected were used to create the AUC curve.
The effect of sucralose on Glucagon Like Peptide -1 (GLP-1) release [ Time Frame: Baseline ] [ Designated as safety issue: No ]
we will measure plasma GLP-1 during a 5-hour modified Oral Glucose Tolerance Test (mOGTT) administered 10 minutes after subjects consume sucralose in water or an equal volume of water without sucralose (control condition).
Complete list of historical versions of study NCT01128829 on ClinicalTrials.gov Archive Site
Not Provided
  • GLP-1 after two week exposure to sucralose [ Time Frame: two weeks ] [ Designated as safety issue: No ]
    The effect of 2-week exposure to sucralose on the plasma levels of GLP-1 (glucagon-like peptide - 1) in response to a 5-h modified oral glucose tolerance test (mOGTT).
  • sucralose taste detection and GLP-1 (glucagon-like peptide - 1) levels [ Time Frame: baseline ] [ Designated as safety issue: No ]
    A measure of subject's ability to taste sucralose will be correlated with the hormonal response of GLP-1 during a 5-hour modified oral glucose tolerance test.
  • post-treatment sucralose taste detection and GLP-1 (glucagon-like peptide - 1) levels [ Time Frame: two weeks ] [ Designated as safety issue: No ]
    A measure of subject's ability to taste sucralose will be correlated with the hormonal response of GLP-1 during a 5-hour modified oral glucose tolerance test.
Not Provided
Not Provided
 
Sugar-replacement Sweeteners, and Blood Sugar Control
Regulation of Incretin Release by Non-nutritive Sweeteners in Humans

Several sugar-replacement sweeteners are currently on the market, including saccharine (ex. Sweet'N Low), aspartame (ex. Equal), and sucralose (ex. Splenda). The purpose of this study is to examine wether non caloric sweeteners affects how well the body works to control blood sugar. The study includes detailed blood sugar testing after drinking liquids that may contain sucralose. The investigators hypothesize that drinking liquids with sucralose will effect the amounts of specific appetite-affecting substances naturally produced by the body.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Obesity
  • Other: Water
    60 ml of water were drank 10 min before doing a OGTT
  • Other: Sucralose
    60 ml of 2 millimolar sucralose were drank 10 min before doing a OGTT
  • Experimental: water-sucralose
    Subjects in this group drank "water" 10 min before drinking a glucose load on their first oral glucose tolerance test (OGTT) and drank "sucralose" 10 min before drinking a glucose load on their second OGTT. The two OGTT were separated on average by 1 week (i.e. washout was approximately 1 week).
    Interventions:
    • Other: Water
    • Other: Sucralose
  • Experimental: sucralose-water
    Subjects in this group drank "sucralose" 10 min before drinking a glucose load on their first OGTT and drank "water" 10 min before drinking a glucose load on their second OGTT. The two OGTT were separated on average by 1 week (i.e. washout was approximately 1 week).
    Interventions:
    • Other: Water
    • Other: Sucralose
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
October 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • body mass index (BMI) over 30.
  • Homeostasis model assessment of insulin resistance (HOMA-IR) < or = 2.6

Exclusion Criteria:

  • smoking or smoked within last six months
  • pregnant or breastfeeding
  • have malabsorptive syndromes
  • intestinal inflammatory disease
  • diabetes
  • liver or kidney disease
  • fructose intolerance
  • consuming more than one can of diet beverage or one spoonful of non-nutritive sweeteners (e.g. sucralose, aspartame, or saccharine) a week.
  • taking any medication that might affect metabolism or taste.
Both
21 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01128829
09-0583/ 201102383
Yes
Marta Yanina Pepino de Gruev, Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Marta Y Pepino de Gruev, Ph.D. Washington University School of Medicine
Washington University School of Medicine
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP