Effects of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism
Primary Purpose
Impaired Glucose Tolerance
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sucralose-Aspartame
Aspartame-Sucralose
Sponsored by
About this trial
This is an interventional basic science trial for Impaired Glucose Tolerance focused on measuring Non-Nutritive Sweeteners, Artificial Sweeteners, Glucose Metabolism, Microbiota, Dysbiosis
Eligibility 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
Sites / Locations
- Richardson Centre for Functional Foods & Nutraceuticals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sucralose-Aspartame
Aspartame-Sucralose
Arm Description
Generic name: sucralose or aspartame, Dosage form: powder, Duration:seven days.
Generic name: aspartame or sucralose, Dosage form: powder, Duration:seven days.
Outcomes
Primary Outcome Measures
Fasting Blood Glucose
Fasting blood glucose level and 2-hour oral glucose tolerance test (OGTT).
Secondary Outcome Measures
Insulin, glucagon,GIP & GLP-1
glucose homeostasis
Fecal Microbiome & short chain fatty acids measurements
to detect bacterial composition in feces and SCFA changes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02569762
Brief Title
Effects of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism
Official Title
Assessment of the Effect of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance
Keywords
Non-Nutritive Sweeteners, Artificial Sweeteners, Glucose Metabolism, Microbiota, Dysbiosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sucralose-Aspartame
Arm Type
Experimental
Arm Description
Generic name: sucralose or aspartame, Dosage form: powder, Duration:seven days.
Arm Title
Aspartame-Sucralose
Arm Type
Experimental
Arm Description
Generic name: aspartame or sucralose, Dosage form: powder, Duration:seven days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Sucralose-Aspartame
Intervention Description
Sucralose or aspartame
Intervention Type
Dietary Supplement
Intervention Name(s)
Aspartame-Sucralose
Intervention Description
Aspartame or sucralose
Primary Outcome Measure Information:
Title
Fasting Blood Glucose
Description
Fasting blood glucose level and 2-hour oral glucose tolerance test (OGTT).
Time Frame
0-200 mins
Secondary Outcome Measure Information:
Title
Insulin, glucagon,GIP & GLP-1
Description
glucose homeostasis
Time Frame
4 times during the 12 weeks period
Title
Fecal Microbiome & short chain fatty acids measurements
Description
to detect bacterial composition in feces and SCFA changes
Time Frame
4 times during the 12 weeks period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James K Friel, Ph.D.
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richardson Centre for Functional Foods & Nutraceuticals
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 2E1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effects of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism
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