NCT02569762

Brief Summary

The Objectives of this study is to determine the effect(s) of daily non-caloric artificial sweetener (NAS) consumption (sucralose or aspartame) on the composition of the bacteria and also to determine the changes in glucose metabolism.

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

Timeline
Completed

Started Jul 2016

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

First Submitted

Initial submission to the registry

July 21, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 13, 2019

Status Verified

May 1, 2018

Enrollment Period

1.5 years

First QC Date

July 21, 2015

Last Update Submit

March 11, 2019

Conditions

Impaired Glucose Tolerance

Keywords

Non-Nutritive SweetenersArtificial SweetenersGlucose MetabolismMicrobiotaDysbiosis

Outcome Measures

Primary Outcomes (1)

  • Fasting Blood Glucose

    Fasting blood glucose level and 2-hour oral glucose tolerance test (OGTT).

    0-200 mins

Secondary Outcomes (2)

  • Insulin, glucagon,GIP & GLP-1

    4 times during the 12 weeks period

  • Fecal Microbiome & short chain fatty acids measurements

    4 times during the 12 weeks period

Study Arms (2)

Sucralose-Aspartame

EXPERIMENTAL

Generic name: sucralose or aspartame, Dosage form: powder, Duration:seven days.

Dietary Supplement: Sucralose-AspartameDietary Supplement: Aspartame-Sucralose

Aspartame-Sucralose

EXPERIMENTAL

Generic name: aspartame or sucralose, Dosage form: powder, Duration:seven days.

Dietary Supplement: Sucralose-AspartameDietary Supplement: Aspartame-Sucralose

Interventions

Sucralose-AspartameDIETARY_SUPPLEMENT

Sucralose or aspartame

Aspartame-SucraloseSucralose-Aspartame
Aspartame-SucraloseDIETARY_SUPPLEMENT

Aspartame or sucralose

Aspartame-SucraloseSucralose-Aspartame

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 20-25 kg/m2
  • Fasting blood glucose (FBG) \< 5.7 mmol/L
  • women with regular menstrual cycle.

You may not qualify if:

  • probiotic or antibiotic use within 6 months prior to the start of the study
  • metabolic or gastrointestinal disorders (diabetes mellitus types 1 and 2, inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), celiac disease, phenylketonuria)
  • pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richardson Centre for Functional Foods & Nutraceuticals

Winnipeg, Manitoba, R3T 2E1, Canada

Location

MeSH Terms

Conditions

Glucose IntoleranceDysbiosis

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • James K Friel, Ph.D.

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2015

First Posted

October 7, 2015

Study Start

July 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

March 13, 2019

Record last verified: 2018-05

Locations

CA(1)