Sugar-replacement Sweeteners, and Blood Sugar Control (SIR)
This study has been completed.
Sponsor:
Washington University School of Medicine
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
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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 Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover 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 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.
| 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 |
| 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
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 |
| Results First Received: | June 2, 2014 |
| Last Updated: | December 15, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Washington University School of Medicine:
|
obesity diabetes artificial sweeteners |
ClinicalTrials.gov processed this record on March 03, 2015