Sugar-replacement Sweeteners, and Blood Sugar Control

Overview

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.

Full Title of Study: “Regulation of Incretin Release by Non-nutritive Sweeteners in Humans”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2012

Interventions

  • 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

Arms, Groups and Cohorts

  • 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).
  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • The Effect of Sucralose on Insulin Concentration (Area Under the Curve; AUC)
    • Time Frame: Baseline
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Washington University School of Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marta Yanina Pepino de Gruev, Research Assistant Professor of Medicine – Washington University School of Medicine
  • Overall Official(s)
    • Marta Y Pepino de Gruev, Ph.D., Principal Investigator, Washington University School of Medicine

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