Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02569762
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of Manitoba

Tracking Information
First Submitted Date  ICMJE July 21, 2015
First Posted Date  ICMJE October 7, 2015
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE July 2016
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2017)
Fasting Blood Glucose [ Time Frame: 0-200 mins ]
Fasting blood glucose level and 2-hour oral glucose tolerance test (OGTT).
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
Blood Glucose Levels change from baseline. [ Time Frame: day 0 (screening), day 28, day 42, day 70, day 84 and data will be presented for up to 12 weeks. ]
Fasting blood glucose test will be done at day 0 (screening), day 28, day 42, day 70, day 84., after an overnight fast of at least 8 hours, as well as throughout a 2-hour oral glucose tolerance test (OGTT).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2017)
  • Insulin, glucagon,GIP & GLP-1 [ Time Frame: 4 times during the 12 weeks period ]
    glucose homeostasis
  • Fecal Microbiome & short chain fatty acids measurements [ Time Frame: 4 times during the 12 weeks period ]
    to detect bacterial composition in feces and SCFA changes
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
Fecal Microbiome [ Time Frame: days 28, 42, 70, and 84 ]
The bacterial composition in feces will be analyzed by 16S rRNA Illumina-based gene sequencing.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism
Official Title  ICMJE Assessment of the Effect of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism
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.
Detailed Description

The trial will be 12 weeks randomized, cross-over and double blinded with 2 treatment intervention ( sucralose and aspartame) , there will be a run in period (4 weeks), then phase 1 treatment period for two weeks followed by four weeks washout period then phase 2 treatment period(2 weeks). Healthy, normglycemic (<5.6 mmol/L) males and females ( 17 total) of age 18-45 y with a body mass index (BMI) 20-25 kg/m2 will be recruited.

Each participants will be given the dose of sweetener aspartame or sucralose during the treatment phase in a double-blind procedure.

the participant will be asked to consume the sweetener in a mixed flavoured beverage during each visit in the treatment phase.

Blood and stool sample collection will take place before after the run-in period, and after the washout period, as well as after each two-week treatment period.

glucose measurement: Capillary blood will be collected during each visit by registered nurse. Blood will be collected at fasting and at 12,30,45,60,90 and 120 minutes after the participants drink a glucose drink (75g glucose) for Oral glucose tolerance test.

a food frequency questionnaire will be given to each participant in order to estimate how often each sweetener is consumed on a daily basis.

Participants will also be asked to complete weekly food diaries of food and drink consumption.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Impaired Glucose Tolerance
Intervention  ICMJE
  • Dietary Supplement: Sucralose-Aspartame
    Sucralose or aspartame
  • Dietary Supplement: Aspartame-Sucralose
    Aspartame or sucralose
Study Arms  ICMJE
  • Experimental: Sucralose-Aspartame
    Generic name: sucralose or aspartame, Dosage form: powder, Duration:seven days.
    Interventions:
    • Dietary Supplement: Sucralose-Aspartame
    • Dietary Supplement: Aspartame-Sucralose
  • Experimental: Aspartame-Sucralose
    Generic name: aspartame or sucralose, Dosage form: powder, Duration:seven days.
    Interventions:
    • Dietary Supplement: Sucralose-Aspartame
    • Dietary Supplement: Aspartame-Sucralose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2019)
17
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2015)
12
Actual Study Completion Date  ICMJE January 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02569762
Other Study ID Numbers  ICMJE B2015:069
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Manitoba
Study Sponsor  ICMJE University of Manitoba
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James K Friel, Ph.D. University of Manitoba
PRS Account University of Manitoba
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP