Impaired Glucose ToleranceNCT02800707
Sucralose, Stevia, Gut Microbiome and Glucose Metabolism
A study testing Sucralose and Stevia in people with Impaired Glucose Tolerance, run by University of Minnesota at 1 site in United States.
Trial summary
This study will determine the influence of two non-caloric sweeteners on glucose metabolism via the gut microbiome in adult men and women. Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Impaired Glucose Tolerance
- What is being tested?
- Sucralose and Stevia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2017to 31 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 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria: Generally health adult men and women aged 35-55 years old -
Exclusion Criteria:Adults will not be eligible who have chronic disease (cancer, CHD, diabetes, chronic kidney disease); pregnant or breast feeding; menopausal; has a history of bariatric surgery; taking prednisone/steroids, taking medication for PCOS, or take medications that influence blood glucose.
-
Trial locations and contacts
1 site in 1 country.
About this study
This study will determine the influence of two non-caloric sweeteners on glucose metabolism via the gut microbiome in adult men and women.
Read the detailed description
This study will determine the influence of two non-caloric sweeteners on glucose metabolism via the gut microbiome in adult men and women aged 35-55 years.
- Conditions
- Impaired Glucose Tolerance
- Being tested
- Sucralose, Stevia
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucraloseOther
Sweetner
SteviaOther
Sweetner
| Study group | Role | What they receive |
|---|---|---|
| Sucralose | Active comparator | Participants will be asked to consume 180 mg/day of sucralose (in the form of capsules which is equivalent to three 12-oz cans of diet soda) for 14 days. According to the FDA, a 150 lb. person may consume up to 340 mg/day of sucralose (or 5.5 12-oz cans of sucralose-sweetened diet soda). Receives: Other: Sucralose |
| Stevia | Active comparator | Participants will be asked to consume 180 mg/day of stevia (in the form of capsules which is equivalent to three 12-oz cans of diet soda) for 14 days. According to the FDA, a 150 lb. person may consume up to 800 mg/day of stevia (or about 12 cans of stevia-sweetened diet soda). Receives: Other: Stevia |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-hour glucose
An oral glucose tolerance test will be administered before and after consuming assigned sweetener to determine change in 2-hour glucose
Measured: 14 days
Secondary outcomes (1)
Gut microbiome
Gut microbiota will be measured before and after consuming assigned sweetener to determine change in gut microbiota.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start3 Jan 2017
- Primary completion31 Jan 2018
- Study completion31 Jan 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 MinnesotaThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lyn M Steffen, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800707
- Sponsor's protocol ID
- 1605M88288
- Status last verified
- Mar 2018
- First submitted
- 10 Jun 2016
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be made available.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sucralose, Stevia, Gut Microbiome and Glucose Metabolism
- ClinicalTrials.gov ID
- NCT02800707
- Acronym / sponsor ID
- 1605M88288
- Conditions
- Impaired Glucose Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 15 Jun 2016 (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.
This study will determine the influence of two non-caloric sweeteners on glucose metabolism via the gut microbiome in adult men and women.
Detailed description
This study will determine the influence of two non-caloric sweeteners on glucose metabolism via the gut microbiome in adult men and women aged 35-55 years.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucralose | Active comparator | Other: SucraloseParticipants will be asked to consume 180 mg/day of sucralose (in the form of capsules which is equivalent to three 12-oz cans of diet soda) for 14 days. According to the FDA, a 150 lb. person may consume up to 340 mg/day of sucralose (or 5.5 12-oz cans of sucralose-sweetened diet soda). |
| Stevia | Active comparator | Other: SteviaParticipants will be asked to consume 180 mg/day of stevia (in the form of capsules which is equivalent to three 12-oz cans of diet soda) for 14 days. According to the FDA, a 150 lb. person may consume up to 800 mg/day of stevia (or about 12 cans of stevia-sweetened diet soda). |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| SucraloseSweetner | Other | Sucralose |
| SteviaSweetner | Other | Stevia |
Primary outcome
2-hour glucose
Time frame: 14 days
An oral glucose tolerance test will be administered before and after consuming assigned sweetener to determine change in 2-hour glucose
1 secondary outcome
Gut microbiome
Time frame: 14 days
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 22 Mar 2018.
- Individual participant dataSharing planned: No. Individual data will not be made available.
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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.
Lyn M Steffen, PhD principal investigator
University of Minnesota
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 and Stevia in people with Impaired Glucose Tolerance, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Mar 2018. 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 United States. 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?
2-hour glucose (time frame: 14 days). 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 22 Mar 2018.