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

History of Changes

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	Other: Water Other: Sucralose


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Regulation of Incretin Release by Non-nutritive Sweeteners in Humans

Further study details as provided by Marta Yanina Pepino de Gruev, Washington University School of Medicine:

Primary Outcome 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.


Enrollment:	17
Study Start Date:	May 2010
Study Completion Date:	October 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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).	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: 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).	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

Eligibility


Ages Eligible for Study:	21 Years to 40 Years (Adult)
Sexes Eligible for Study:	All
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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
Results First Received:	June 2, 2014
Last Updated:	December 15, 2014

Keywords provided by Marta Yanina Pepino de Gruev, Washington University School of Medicine:


obesity diabetes artificial sweeteners

ClinicalTrials.gov processed this record on July 21, 2017

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