Effects of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism

Assessment of the Effect of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism

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.

Study Overview

• Status: Completed
• Conditions: Impaired Glucose Tolerance
• Intervention / Treatment: Dietary supplement: Sucralose-Aspartame; Dietary supplement: Aspartame-Sucralose

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: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T 2E1
      • Richardson Centre for Functional Foods & Nutraceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Blood Glucose	Fasting blood glucose level and 2-hour oral glucose tolerance test (OGTT).	0-200 mins

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin, glucagon,GIP & GLP-1	glucose homeostasis	4 times during the 12 weeks period
Fecal Microbiome & short chain fatty acids measurements	to detect bacterial composition in feces and SCFA changes	4 times during the 12 weeks period

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: James K Friel, Ph.D., University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: July 21, 2015
• First Submitted That Met QC Criteria: October 5, 2015
• First Posted (Estimate): October 7, 2015

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Microbiota; Non-Nutritive Sweeteners; Dysbiosis; Glucose Metabolism; Artificial Sweeteners
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance
• Other Study ID Numbers: B2015:069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided