Effects of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism

Impaired Glucose Tolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569762
• Other study ID #: B2015:069
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: January 2018

Study information

• Verified date: May 2018
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

Dietary Supplement:
• Sucralose-Aspartame
Sucralose or aspartame
• Aspartame-Sucralose
Aspartame or sucralose

Locations

Country	Name	City	State
Canada	Richardson Centre for Functional Foods & Nutraceuticals	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Blood Glucose	Fasting blood glucose level and 2-hour oral glucose tolerance test (OGTT).	0-200 mins
Secondary	Insulin, glucagon,GIP & GLP-1	glucose homeostasis	4 times during the 12 weeks period
Secondary	Fecal Microbiome & short chain fatty acids measurements	to detect bacterial composition in feces and SCFA changes	4 times during the 12 weeks period