NCT01128829

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started May 2010

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

December 22, 2014

Completed
Last Updated

December 22, 2014

Status Verified

December 1, 2014

Enrollment Period

1.8 years

First QC Date

May 20, 2010

Results QC Date

June 2, 2014

Last Update Submit

December 15, 2014

Conditions

Obesity

Keywords

obesitydiabetesartificial sweeteners

Outcome Measures

Primary Outcomes (1)

  • The Effect of Sucralose on Insulin Concentration (Area Under the Curve; AUC)

    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.

    Baseline

Study Arms (2)

water-sucralose

EXPERIMENTAL

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: WaterOther: Sucralose

sucralose-water

EXPERIMENTAL

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: WaterOther: Sucralose

Interventions

WaterOTHER

60 ml of water were drank 10 min before doing a OGTT

sucralose-waterwater-sucralose
SucraloseOTHER

60 ml of 2 millimolar sucralose were drank 10 min before doing a OGTT

sucralose-waterwater-sucralose

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • body mass index (BMI) over 30.
  • Homeostasis model assessment of insulin resistance (HOMA-IR) \< or = 2.6

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • 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.

    PMID: 23633524DERIVED

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Interventions

Watertrichlorosucrose

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Results Point of Contact

Title
M. Yanina Pepino
Organization
Washington University School of Medicine
ypepino@dom.wustl.edu
3143628113

Study Officials

  • Marta Y Pepino de Gruev, Ph.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor of Medicine

Study Record Dates

First Submitted

May 20, 2010

First Posted

May 24, 2010

Study Start

May 1, 2010

Primary Completion

February 1, 2012

Study Completion

October 1, 2012

Last Updated

December 22, 2014

Results First Posted

December 22, 2014

Record last verified: 2014-12

Locations

US(1)