Overview

This trial is active, not recruiting.

Condition obesity
Treatment sucralose
Sponsor Washington University School of Medicine
Start date May 2010
End date April 2012
Trial size 17 participants
Trial identifier NCT01128829, 09-0583/ 201102383

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacodynamics study
Intervention model single group assignment
Masking open label
Primary purpose basic science

Primary Outcomes

Measure
The effect of sucralose on Glucagon Like Peptide -1 (GLP-1) release
time frame: Baseline

Secondary Outcomes

Measure
sucralose taste detection and GLP-1 (glucagon-like peptide - 1) levels
time frame: baseline

Eligibility Criteria

Male or female participants from 21 years up to 40 years old.

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.

Additional Information

Official title Regulation of Incretin Release by Non-nutritive Sweeteners in Humans
Principal investigator Marta Y Pepino de Gruev, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.