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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

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.

Condition or disease Intervention/treatment Phase
Impaired Glucose Tolerance Dietary Supplement: Sucralose-Aspartame Dietary Supplement: Aspartame-Sucralose Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Assessment of the Effect of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism
Actual Study Start Date : July 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Aspartame

Arm Intervention/treatment
Experimental: Sucralose-Aspartame
Generic name: sucralose or aspartame, Dosage form: powder, Duration:seven days.
Dietary Supplement: Sucralose-Aspartame
Sucralose or aspartame

Dietary Supplement: Aspartame-Sucralose
Aspartame or sucralose

Experimental: Aspartame-Sucralose
Generic name: aspartame or sucralose, Dosage form: powder, Duration:seven days.
Dietary Supplement: Sucralose-Aspartame
Sucralose or aspartame

Dietary Supplement: Aspartame-Sucralose
Aspartame or sucralose




Primary Outcome Measures :
  1. Fasting Blood Glucose [ Time Frame: 0-200 mins ]
    Fasting blood glucose level and 2-hour oral glucose tolerance test (OGTT).


Secondary Outcome Measures :
  1. Insulin, glucagon,GIP & GLP-1 [ Time Frame: 4 times during the 12 weeks period ]
    glucose homeostasis

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569762


Locations
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Canada, Manitoba
Richardson Centre for Functional Foods & Nutraceuticals
Winnipeg, Manitoba, Canada, R3T 2E1
Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: James K Friel, Ph.D. University of Manitoba
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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT02569762    
Other Study ID Numbers: B2015:069
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Manitoba:
Non-Nutritive Sweeteners
Artificial Sweeteners
Glucose Metabolism
Microbiota
Dysbiosis
Additional relevant MeSH terms:
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Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases