Sugar-replacement Sweeteners, Taste Perception, and Blood Sugar Control (ADAYP)

This study is ongoing, but not recruiting participants.
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: October 22, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Obesity
Dietary Supplement: Sucralose

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Regulation of Incretin Release by Non-nutritive Sweeteners in Humans

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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, glucose, C-peptide and 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 17
Study Start Date: May 2010
Estimated Study Completion Date: February 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Sucralose
    Subjects will receive sucralose or water 10 minutes before a glucose tolerance test
  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01128829

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Marta Y Pepino de Gruev, Ph.D. Washington University School of Medicine
  More Information

No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marta Yanina Pepino de Gruev, Research Assistant Professor of Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01128829     History of Changes
Other Study ID Numbers: 09-0583/ 201102383
Study First Received: May 20, 2010
Last Updated: October 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
obesity
diabetes
artificial sweeteners

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014