HealthyNCT02650947
Sucralose Effects on Glucose Metabolism and Gut Microbiota
A study testing Sucralose in people with Healthy, run by Ramathibodi Hospital at 1 site in Thailand.
Trial summary
Hypothesis: 1. Long-term consumption of sucralose may effect glucose metabolism, incretin hormone secretion and gut microbiota in healthy adults. 2. Long-term consumption of sucralose may alter food behaviour in healthy adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sucralose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2016to Apr 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers without underlying disease
- Normal oral glucose tolerance test
- Agree to participate by written informed consent
Who cannot join
- Shift workers
- History of diabetes mellitus or prediabetes (impaired fasting glucose and/or glucose tolerance test)
- Malabsorption problem
- Regular consumption of nonnutritive sweeteners
- Liver impairment (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3-folds upper normal limit)
- Renal impairment (serum creatinine >1.5 mg/dL)
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- Use of medications affecting glucose level such as glucocorticoid, estrogen, androgen
- Pregnant and lactating woman
- Smoking within 6 months
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, 10400
About this study
Official title: Effects of Sucralose Consumption on Glucose Metabolism, Incretin and Gut Microbiota in Healthy Adult
Hypothesis:
- Long-term consumption of sucralose may effect glucose metabolism, incretin hormone secretion and gut microbiota in healthy adults.
- Long-term consumption of sucralose may alter food behaviour in healthy adults.
Read the detailed description
Artificial sweeteners such as sucralose, are among the most widely used food additives worldwide. Artificial sweetener consumption is considered safe and beneficial owing to their low caloric content. However, many emerging evidences showed artificial sweeteners may induce glucose intolerance. The objectives of this study were to determine the effect of sucralose on glycemic response, insulin secretion, insulin sensitivity, incretin response, gut microbiota and food behavior in healthy subjects.
- Conditions
- Healthy
- Being tested
- Sucralose, Placebo
- Keywords
- Sucralose, Insulin Secretion, Insulin Sensitivity, Incretin, Gut Microbiota, Food and Eating Behaviour, Healthy Volunteers
- Medical subject headings
- Insulin Resistance, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucraloseDietary supplement
Also called Trichlorosucrose
Consumption of capsules containing either 200 mg sucralose (equivalent to diet soda 3 cans) per day for four weeks
PlaceboDietary supplement
Consumption of empty capsule everyday for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sucralose | Experimental | Subjects in this group ate capsule filled with sucralose 200 mg for 4 weeks (week 1-4) and measured oral glucose tolerance test (OGTT), acute insulin response (AIR), and gut microbe examination at week 4. Receives: Dietary Supplement: Sucralose |
| Placebo | Placebo comparator | Subjects ate empty capsule (placebo) for 4 weeks (week 1-4) and measured OGTT, AIR, and gut microbe examination at week 4. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of sucralose on insulin secretion
We will measure plasma insulin concentrations before and at 0, 2, 3, 4, 5, 6, 8, 10 minutes after administered intravenously 50%glucose 0.3 g/kg within 1 minute. All these data collected were used to calculate acute insulin response to glucose.
Measured: 2 hours
Secondary outcomes (4)
Glucagon-like peptide-1 secretion
Measured: 2 hours
Gut microbiota
stool exam, polymerase chain reaction for 16s RNA gene using next generation sequencing
Measured: 4 weeks
Food record
Measured: 4 weeks
The effect of sucralose on insulin sensitivity
We will measure plasma insulin concentrations during an oral glucose tolerance test.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Endocrine Society of Thailand
- Responsible party
- Principal investigator, Chutintorn Sriphrapradang, Ramathibodi Hospital
- Investigators
- Chutintorn Sriphrapradang, M.D., Principal investigator, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650947
- Sponsor's protocol ID
- 09-58-16
- Status last verified
- Apr 2017
- First submitted
- 2 Jan 2016
- Last updated
- 27 Apr 2017
- 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 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sucralose Consumption on Glucose Metabolism, Incretin and Gut Microbiota in Healthy Adult
- ClinicalTrials.gov ID
- NCT02650947
- Acronym / sponsor ID
- 09-58-16
- Conditions
- Healthy
- Keywords
- Sucralose, Insulin Secretion, Insulin Sensitivity, Incretin, Gut Microbiota, Food and Eating Behaviour, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Collaborators
- The Endocrine Society of Thailand
- Study start
- Jan 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 8 Jan 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.
Hypothesis:
- Long-term consumption of sucralose may effect glucose metabolism, incretin hormone secretion and gut microbiota in healthy adults.
- Long-term consumption of sucralose may alter food behaviour in healthy adults.
Detailed description
Artificial sweeteners such as sucralose, are among the most widely used food additives worldwide. Artificial sweetener consumption is considered safe and beneficial owing to their low caloric content. However, many emerging evidences showed artificial sweeteners may induce glucose intolerance. The objectives of this study were to determine the effect of sucralose on glycemic response, insulin secretion, insulin sensitivity, incretin response, gut microbiota and food behavior in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucralose | Experimental | Dietary Supplement: SucraloseSubjects in this group ate capsule filled with sucralose 200 mg for 4 weeks (week 1-4) and measured oral glucose tolerance test (OGTT), acute insulin response (AIR), and gut microbe examination at week 4. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects ate empty capsule (placebo) for 4 weeks (week 1-4) and measured OGTT, AIR, and gut microbe examination at week 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers without underlying disease
- Normal oral glucose tolerance test
- Agree to participate by written informed consent
Key exclusion criteria (9 listed)
- Shift workers
- History of diabetes mellitus or prediabetes (impaired fasting glucose and/or glucose tolerance test)
- Malabsorption problem
- Regular consumption of nonnutritive sweeteners
- Liver impairment (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3-folds upper normal limit)
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 |
|---|---|---|
| SucraloseAlso: TrichlorosucroseConsumption of capsules containing either 200 mg sucralose (equivalent to diet soda 3 cans) per day for four weeks | Dietary supplement | Sucralose |
| PlaceboConsumption of empty capsule everyday for 4 weeks | Dietary supplement | Placebo |
Primary outcome
The effect of sucralose on insulin secretion
Time frame: 2 hours
We will measure plasma insulin concentrations before and at 0, 2, 3, 4, 5, 6, 8, 10 minutes after administered intravenously 50%glucose 0.3 g/kg within 1 minute. All these data collected were used to calculate acute insulin response to glucose.
4 secondary outcomes
Glucagon-like peptide-1 secretion
Time frame: 2 hours
Gut microbiota
Time frame: 4 weeks
Food record
Time frame: 4 weeks
The effect of sucralose on insulin sensitivity
Time frame: 2 hours
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 27 Apr 2017.
- 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.
Chutintorn Sriphrapradang, M.D. principal investigator
Ramathibodi Hospital
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 in people with Healthy, run by Ramathibodi Hospital at 1 site in Thailand.
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 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 27 Apr 2017. 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 Thailand. 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. Some participants in this study may receive a placebo. 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?
The effect of sucralose on insulin secretion (time frame: 2 hours). 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 27 Apr 2017.