Impaired Glucose ToleranceNCT02569762
Effects of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism
A study testing Sucralose-Aspartame and Aspartame-Sucralose in people with Impaired Glucose Tolerance, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Impaired Glucose Tolerance
- What is being tested?
- Sucralose-Aspartame and Aspartame-Sucralose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 20-25 kg/m2
- Fasting blood glucose (FBG) < 5.7 mmol/L
- women with regular menstrual cycle.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Richardson Centre for Functional Foods & Nutraceuticals
Winnipeg, Manitoba, R3T 2E1
About this study
Official title: 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.
Read the 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.
- Conditions
- Impaired Glucose Tolerance
- Being tested
- Sucralose-Aspartame, Aspartame-Sucralose
- Keywords
- Non-Nutritive Sweeteners, Artificial Sweeteners, Glucose Metabolism, Microbiota, Dysbiosis
- Medical subject headings
- Glucose Intolerance, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sucralose-AspartameDietary supplement
Sucralose or aspartame
Aspartame-SucraloseDietary supplement
Aspartame or sucralose
| Study group | Role | What they receive |
|---|---|---|
| Sucralose-Aspartame | Experimental | Generic name: sucralose or aspartame, Dosage form: powder, Duration:seven days. Receives: Dietary Supplement: Sucralose-Aspartame; Dietary Supplement: Aspartame-Sucralose |
| Aspartame-Sucralose | Experimental | Generic name: aspartame or sucralose, Dosage form: powder, Duration:seven days. Receives: Dietary Supplement: Sucralose-Aspartame; Dietary Supplement: Aspartame-Sucralose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Blood Glucose
Fasting blood glucose level and 2-hour oral glucose tolerance test (OGTT).
Measured: 0-200 mins
Secondary outcomes (2)
Insulin, glucagon,GIP & GLP-1
glucose homeostasis
Measured: 4 times during the 12 weeks period
Fecal Microbiome & short chain fatty acids measurements
to detect bacterial composition in feces and SCFA changes
Measured: 4 times during the 12 weeks period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startJul 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Glucose ToleranceStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James K Friel, Ph.D., Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569762
- Sponsor's protocol ID
- B2015:069
- Status last verified
- May 2018
- First submitted
- 21 Jul 2015
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism
- ClinicalTrials.gov ID
- NCT02569762
- Acronym / sponsor ID
- B2015:069
- Conditions
- Impaired Glucose Tolerance
- Keywords
- Non-Nutritive Sweeteners, Artificial Sweeteners, Glucose Metabolism, Microbiota, Dysbiosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucralose-Aspartame | Experimental | Dietary Supplement: Sucralose-Aspartame, Dietary Supplement: Aspartame-SucraloseGeneric name: sucralose or aspartame, Dosage form: powder, Duration:seven days. |
| Aspartame-Sucralose | Experimental | Dietary Supplement: Sucralose-Aspartame, Dietary Supplement: Aspartame-SucraloseGeneric name: aspartame or sucralose, Dosage form: powder, Duration:seven days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI between 20-25 kg/m2
- Fasting blood glucose (FBG) < 5.7 mmol/L
- women with regular menstrual cycle.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sucralose-AspartameSucralose or aspartame | Dietary supplement | Aspartame-Sucralose, Sucralose-Aspartame |
| Aspartame-SucraloseAspartame or sucralose | Dietary supplement | Aspartame-Sucralose, Sucralose-Aspartame |
Primary outcome
Fasting Blood Glucose
Time frame: 0-200 mins
Fasting blood glucose level and 2-hour oral glucose tolerance test (OGTT).
2 secondary outcomes
Insulin, glucagon,GIP & GLP-1
Time frame: 4 times during the 12 weeks period
Fecal Microbiome & short chain fatty acids measurements
Time frame: 4 times during the 12 weeks period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James K Friel, Ph.D. principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sucralose-Aspartame and Aspartame-Sucralose in people with Impaired Glucose Tolerance, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Blood Glucose (time frame: 0-200 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.