Sugar-replacement Sweeteners, and Blood Sugar Control (SIR)
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ClinicalTrials.gov Identifier: NCT01128829 |
Recruitment Status :
Completed
First Posted : May 24, 2010
Results First Posted : December 22, 2014
Last Update Posted : December 22, 2014
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Condition or disease | Intervention/treatment | Phase |
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Obesity | Other: Water Other: Sucralose | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 17 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Regulation of Incretin Release by Non-nutritive Sweeteners in Humans |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | February 2012 |
Actual Study Completion Date : | October 2012 |

Arm | Intervention/treatment |
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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).
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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).
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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 |
- 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.

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Ages Eligible for Study: | 21 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128829
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | Marta Y Pepino de Gruev, Ph.D. | Washington University School of Medicine |
Responsible Party: | Marta Yanina Pepino de Gruev, Research Assistant Professor of Medicine, Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT01128829 |
Other Study ID Numbers: |
09-0583/ 201102383 |
First Posted: | May 24, 2010 Key Record Dates |
Results First Posted: | December 22, 2014 |
Last Update Posted: | December 22, 2014 |
Last Verified: | December 2014 |
obesity diabetes artificial sweeteners |
Obesity Overnutrition Nutrition Disorders Overweight Body Weight |