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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

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

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

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

NCT ID

NCT02569762

First Posted

July 21, 2015

Last Updated

March 11, 2019

Sponsor

University of Manitoba

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

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

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Effects of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism

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