Effects of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism

NCT ID: NCT02569762

Last Updated: 2019-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-01-31

Brief Summary

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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

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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.

Conditions

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Impaired Glucose Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sucralose-Aspartame

Generic name: sucralose or aspartame, Dosage form: powder, Duration:seven days.

Group Type EXPERIMENTAL

Sucralose-Aspartame

Intervention Type DIETARY_SUPPLEMENT

Sucralose or aspartame

Aspartame-Sucralose

Intervention Type DIETARY_SUPPLEMENT

Aspartame or sucralose

Aspartame-Sucralose

Generic name: aspartame or sucralose, Dosage form: powder, Duration:seven days.

Group Type EXPERIMENTAL

Sucralose-Aspartame

Intervention Type DIETARY_SUPPLEMENT

Sucralose or aspartame

Aspartame-Sucralose

Intervention Type DIETARY_SUPPLEMENT

Aspartame or sucralose

Interventions

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Sucralose-Aspartame

Sucralose or aspartame

Intervention Type DIETARY_SUPPLEMENT

Aspartame-Sucralose

Aspartame or sucralose

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James K Friel, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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Richardson Centre for Functional Foods & Nutraceuticals

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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B2015:069

Identifier Type: -

Identifier Source: org_study_id

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