NCT02589002

Brief Summary

In this study the effects of sucralose on insulin sensitivity, beta-cell response and appetite regulating hormones will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

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

July 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

November 13, 2017

Status Verified

August 1, 2016

Enrollment Period

1.7 years

First QC Date

October 15, 2015

Last Update Submit

November 8, 2017

Conditions

Glucose Metabolism Disorders

Keywords

sucraloseinsulin sensitivitybeta-cell responseappetite regulating hormone

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    Insulin sensitivity and pancreatic response estimated with the minimal model using a frequently sampled IV glucose tolerance test

    Two weeks

Secondary Outcomes (4)

  • Glucagon like peptide (GLP-1) change

    Two weeks

  • Ghrelin change

    Two weeks

  • Tyrosine-tyrosine peptide (PYY) change

    Two weeks

  • Leptin change

    Two weeks

Study Arms (2)

Sucralose

EXPERIMENTAL

Ingestion of 15% of the ADI of sucralose daily during two weeks

Other: Sucralose

Control

NO INTERVENTION

Absence of sucralose ingestion

Interventions

SucraloseOTHER
Also known as: Non-nutritive sweetener
Sucralose

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • both genders
  • age between 18 and 55 years
  • body mass index ≥18.5 and \<25 kg/m2
  • low consumption of non-nutritive sweeteners

You may not qualify if:

  • diabetes or glucose intolerance
  • consumption of medications affecting insulin sensitivity (metformin, steroids, hormone replacement therapy, contraceptives)
  • intestinal disease such as malabsorption or previous intestinal resection
  • history of bariatric surgery
  • pregnancy or lactation
  • weight loss greater than 5% in the previous month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico City, 14080, Mexico

Location

Related Publications (4)

  • Suez J, Korem T, Zeevi D, Zilberman-Schapira G, Thaiss CA, Maza O, Israeli D, Zmora N, Gilad S, Weinberger A, Kuperman Y, Harmelin A, Kolodkin-Gal I, Shapiro H, Halpern Z, Segal E, Elinav E. Artificial sweeteners induce glucose intolerance by altering the gut microbiota. Nature. 2014 Oct 9;514(7521):181-6. doi: 10.1038/nature13793. Epub 2014 Sep 17.

    PMID: 25231862BACKGROUND

  • Brown RJ, Walter M, Rother KI. Effects of diet soda on gut hormones in youths with diabetes. Diabetes Care. 2012 May;35(5):959-64. doi: 10.2337/dc11-2424. Epub 2012 Mar 12.

    PMID: 22410815BACKGROUND

  • 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: 23633524RESULT

  • Romo-Romo A, Aguilar-Salinas CA, Brito-Cordova GX, Gomez-Diaz RA, Almeda-Valdes P. Sucralose decreases insulin sensitivity in healthy subjects: a randomized controlled trial. Am J Clin Nutr. 2018 Sep 1;108(3):485-491. doi: 10.1093/ajcn/nqy152.

    PMID: 30535090DERIVED

MeSH Terms

Conditions

Glucose Metabolism DisordersInsulin Resistance

Interventions

trichlorosucrose

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinism

Study Officials

  • Paloma Almeda-Valdes, MD, PhD

    Attending Physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2015

First Posted

October 28, 2015

Study Start

July 1, 2015

Primary Completion

March 1, 2017

Study Completion

June 1, 2017

Last Updated

November 13, 2017

Record last verified: 2016-08

Locations

ME(1)