Clinical trial NCT02569762: 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
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Glucose Tolerance
Keywords: Non-Nutritive Sweeteners
Artificial Sweeteners
Glucose Metabolism
Microbiota
Dysbiosis
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Fasting Blood Glucose
timeFrame: 0-200 mins
Secondary outcomes:
measure: Insulin, glucagon,GIP & GLP-1
timeFrame: 4 times during the 12 weeks period
measure: Fecal Microbiome & short chain fatty acids measurements
timeFrame: 4 times during the 12 weeks period
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods & Nutraceuticals
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: James K Friel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: