ObesitySIRNCT01128829
Sugar-replacement Sweeteners, and Blood Sugar Control
A study testing Water and Sucralose in people with Obesity, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Several sugar-replacement sweeteners are currently on the market, including saccharine (ex. Sweet'N Low), aspartame (ex. Equal), and sucralose (ex. Splenda). The purpose of this study is to examine wether non caloric sweeteners affects how well the body works to control blood sugar. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Water and Sucralose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Oct 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index (BMI) over 30.
- Homeostasis model assessment of insulin resistance (HOMA-IR) < or = 2.6
Who cannot join
- smoking or smoked within last six months
- pregnant or breastfeeding
- have malabsorptive syndromes
- intestinal inflammatory disease
- diabetes
- liver or kidney disease
Show all 9Show fewer
- fructose intolerance
- consuming more than one can of diet beverage or one spoonful of non-nutritive sweeteners (e.g. sucralose, aspartame, or saccharine) a week.
- taking any medication that might affect metabolism or taste.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Regulation of Incretin Release by Non-nutritive Sweeteners in Humans
Several sugar-replacement sweeteners are currently on the market, including saccharine (ex. Sweet'N Low), aspartame (ex. Equal), and sucralose (ex. Splenda). The purpose of this study is to examine wether non caloric sweeteners affects how well the body works to control blood sugar. The study includes detailed blood sugar testing after drinking liquids that may contain sucralose. The investigators hypothesize that drinking liquids with sucralose will effect the amounts of specific appetite-affecting substances naturally produced by the body.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterOther
60 ml of water were drank 10 min before doing a OGTT
SucraloseOther
60 ml of 2 millimolar sucralose were drank 10 min before doing a OGTT
| Study group | Role | What they receive |
|---|---|---|
| water-sucralose | Experimental | Subjects in this group drank "water" 10 min before drinking a glucose load on their first oral glucose tolerance test (OGTT) and drank "sucralose" 10 min before drinking a glucose load on their second OGTT. The two OGTT were separated on average by 1 week (i.e. washout was approximately 1 week). Receives: Other: Water; Other: Sucralose |
| sucralose-water | Experimental | Subjects in this group drank "sucralose" 10 min before drinking a glucose load on their first OGTT and drank "water" 10 min before drinking a glucose load on their second OGTT. The two OGTT were separated on average by 1 week (i.e. washout was approximately 1 week). Receives: Other: Water; Other: Sucralose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Sucralose on Insulin Concentration (Area Under the Curve; AUC)
we will measure plasma insulin concentrations during a 5-hour modified Oral Glucose Tolerance Test (mOGTT) administered 10 minutes after subjects consume sucralose in water or an equal volume of water without sucralose (control condition).Plasma insulin concentrations were measured at 20, 15, 10, 6, and 2 min before and at 10, 20, 30, 40, 60, 90, 120, 150,180, 240, and 300 min after ingesting 75g of glucose. All these data collected were used to create the AUC curve.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Yanina Pepino de Gruev, Washington University School of Medicine
- Investigators
- Marta Y Pepino de Gruev, Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128829
- Sponsor's protocol ID
- 09-0583/ 201102383
- Acronym
- SIR
- Status last verified
- Dec 2014
- First submitted
- 20 May 2010
- Last updated
- 22 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pepino MY, Tiemann CD, Patterson BW, Wice BM, Klein S. Sucralose affects glycemic and hormonal responses to an oral glucose load. Diabetes Care. 2013 Sep;36(9):2530-5. doi: 10.2337/dc12-2221. Epub 2013 Apr 30.
PubMed 23633524
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Incretin Release by Non-nutritive Sweeteners in Humans
- ClinicalTrials.gov ID
- NCT01128829
- Acronym / sponsor ID
- SIR / 09-0583/ 201102383
- Conditions
- Obesity
- Keywords
- obesity, diabetes, artificial sweeteners
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Posted 22 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Several sugar-replacement sweeteners are currently on the market, including saccharine (ex. Sweet'N Low), aspartame (ex. Equal), and sucralose (ex. Splenda). The purpose of this study is to examine wether non caloric sweeteners affects how well the body works to control blood sugar. The study includes detailed blood sugar testing after drinking liquids that may contain sucralose. The investigators hypothesize that drinking liquids with sucralose will effect the amounts of specific appetite-affecting substances naturally produced by the body.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| water-sucralose | Experimental | Other: Water, Other: SucraloseSubjects in this group drank "water" 10 min before drinking a glucose load on their first oral glucose tolerance test (OGTT) and drank "sucralose" 10 min before drinking a glucose load on their second OGTT. The two OGTT were separated on average by 1 week (i.e. washout was approximately 1 week). |
| sucralose-water | Experimental | Other: Water, Other: SucraloseSubjects in this group drank "sucralose" 10 min before drinking a glucose load on their first OGTT and drank "water" 10 min before drinking a glucose load on their second OGTT. The two OGTT were separated on average by 1 week (i.e. washout was approximately 1 week). |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- body mass index (BMI) over 30.
- Homeostasis model assessment of insulin resistance (HOMA-IR) < or = 2.6
Key exclusion criteria (9 listed)
- smoking or smoked within last six months
- pregnant or breastfeeding
- have malabsorptive syndromes
- intestinal inflammatory disease
- diabetes
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 |
|---|---|---|
| Water60 ml of water were drank 10 min before doing a OGTT | Other | sucralose-water, water-sucralose |
| Sucralose60 ml of 2 millimolar sucralose were drank 10 min before doing a OGTT | Other | sucralose-water, water-sucralose |
Primary outcome
The Effect of Sucralose on Insulin Concentration (Area Under the Curve; AUC)
Time frame: Baseline
we will measure plasma insulin concentrations during a 5-hour modified Oral Glucose Tolerance Test (mOGTT) administered 10 minutes after subjects consume sucralose in water or an equal volume of water without sucralose (control condition).Plasma insulin concentrations were measured at 20, 15, 10, 6, and 2 min before and at 10, 20, 30, 40, 60, 90, 120, 150,180, 240, and 300 min after ingesting 75g of glucose. All these data collected were used to create the AUC curve.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23633524Pepino MY, Tiemann CD, Patterson BW, Wice BM, Klein S. Sucralose affects glycemic and hormonal responses to an oral glucose load. Diabetes Care. 2013 Sep;36(9):2530-5. doi: 10.2337/dc12-2221. Epub 2013 Apr 30.
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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.
Marta Y Pepino de Gruev, Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water and Sucralose in people with Obesity, run by Washington University School of Medicine 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?
The sponsor lists 2 inclusion and 9 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 22 Dec 2014. 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?
Yes. Results are posted in the registry (first posted 22 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Effect of Sucralose on Insulin Concentration (Area Under the Curve; AUC) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01128829, which also lists 1 linked publication.
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 Dec 2014.