ObesityISTAR-microNCT03032640
Interactions of Human Gut Microbiota With Intestinal Sweet Taste Receptors
A study testing Oral Glucose Tolerance Test (OGTT), Assessment of dietary compliance and Stool sampling in people with Obesity, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to collect data to examine whether short-term consumption of non-caloric artificial sweeteners (NCASs), such as saccharin, can lead to changes in blood sugar levels and in the composition of the bacteria in the large intestine. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Oral Glucose Tolerance Test (OGTT), Assessment of dietary compliance and Stool sampling
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2017to 18 Oct 2022
- 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
- Able to provide written informed consent
- Age 18-45 years
- Weight stable (± 3 kg) during the 6 months prior to enrollment
- BMI ≤ 25 kg/m2
- Consumption of less than a can of diet beverage or a spoonful of NCASs weekly (or each equivalent from foods) during the past month
Who cannot join
- Known coronary artery disease, angina or congestive heart failure
- Type 1 or Type 2 Diabetes (A1c ≥6.5%)
- Bleeding disorders
- Hemoglobin level < 12.5 g/dL for women; hemoglobin level < 13.0 g/dL for men
- Acute or chronic infections
- Hepatitis and/or cirrhosis
Show all 25Show fewer
- Severe asthma or chronic obstructive pulmonary disease
- Renal insufficiency or nephritis (creatinine > 1.6 mg/dl)
- Prior bariatric surgery
- Inflammatory bowel disease or malabsorption
- Cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ)
- Psychiatric disorders or eating disorders
- Cushing's disease or syndrome
- Untreated or inadequately controlled hypo- or hyperthyroidism (abnormal TSH)
- Active rheumatoid arthritis or other inflammatory rheumatic disorder
- Pregnant or nursing women
- Smoking (smoking within the past 3 months)
- Less than 4 bowel movements per week
- Known hypersensitivity to saccharin, lactisole or any of its excipients.
- Excluded medications include but are not limited to:
- Anti-diabetic agents
- Oral, injected or chronic topical steroids (inhaled steroids for mild asthma are acceptable)
- Antibiotic use (within the past 3 months)
- Other drugs known to affect immune or metabolic function
- Orlistat, phentermine, topiramate or other weight loss or anorectic agents (tricyclic antidepressants, atypical antipsychotics or other psychiatric drugs with effects on body weight)
Trial locations and contacts
1 site in 1 country.
United States1 site
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, 32804
About this study
The purpose of this study is to collect data to examine whether short-term consumption of non-caloric artificial sweeteners (NCASs), such as saccharin, can lead to changes in blood sugar levels and in the composition of the bacteria in the large intestine.
- Conditions
- Obesity
- Being tested
- Oral Glucose Tolerance Test (OGTT), Assessment of dietary compliance, Stool sampling, Sodium Saccharin, Placebo
- Keywords
- Glucose, Sweet taste receptors, Artificial sweeteners
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Glucose Tolerance Test (OGTT)Other
Once we test the fasting plasma glucose (after an overnight fast), subject will receive a 75g glucose beverage they will have to drink within 5 minutes. Then after drinking the beverage, 8 blood samples will be collected through the IV catheter, over the next 3 hours.
Assessment of dietary complianceOther
Assessment of consumption of non-caloric artificial sweeteners
Stool samplingOther
Subjects will provide a stool sample.
Sodium SaccharinOther
Subjects in group 1 and group 3 will be provided with sodium saccharin.
PlaceboOther
Subjects in group 2 will be provided with placebo.
LactisoleOther
Subjects in group 3 and group 4 will be provided with lactisole.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- Healthy Lean subjects | Active comparator | Group 1 will receive Sodium Saccharin 200mg capsule, 2x/day, Day 1-14 Receives: Other: Oral Glucose Tolerance Test (OGTT); Other: Assessment of dietary compliance; Other: Stool sampling; Other: Sodium Saccharin |
| Group 2- Healthy Lean subjects | Active comparator | Group 2 will receive Placebo 500mg capsule, 2x/day, Day 1-14 Receives: Other: Oral Glucose Tolerance Test (OGTT); Other: Assessment of dietary compliance; Other: Stool sampling; Other: Placebo |
| Group 3- Healthy Lean subjects | Active comparator | Group 3 will receive Sodium Saccharin 200mg + lactisole 335mg capsule, 2x/day, Day 1-14 Receives: Other: Oral Glucose Tolerance Test (OGTT); Other: Assessment of dietary compliance; Other: Stool sampling; Other: Sodium Saccharin; Other: Lactisole |
| Group 4- Healthy Lean subjects | Active comparator | Group 4 will receive Lactisole 335mg capsule, 2x/day, Day 1-14 Receives: Other: Oral Glucose Tolerance Test (OGTT); Other: Assessment of dietary compliance; Other: Stool sampling; Other: Lactisole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood analyzed by way of NOVA StatStrip Meter and Milliplex Map Kit.
Measured: 6 weeks
Secondary outcomes (1)
Short chain fatty acid analyses
Stool sample aliquoted and frozen by way of ribosomal sequencing, which will be used to determine what bacteria is in the fecal sample.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start26 Jan 2017
- Primary completion21 Mar 2018
- Study completion18 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Pratley, MD, Principal investigator, Translational Research Institute for Metabolism and Diabetes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032640
- Sponsor's protocol ID
- TRIMDFH 982524
- Acronym
- ISTAR-micro
- Status last verified
- Feb 2023
- First submitted
- 11 Nov 2016
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Swithers SE. Artificial sweeteners produce the counterintuitive effect of inducing metabolic derangements. Trends Endocrinol Metab. 2013 Sep;24(9):431-41. doi: 10.1016/j.tem.2013.05.005. Epub 2013 Jul 10.
PubMed 23850261Tilg H, Kaser A. Gut microbiome, obesity, and metabolic dysfunction. J Clin Invest. 2011 Jun;121(6):2126-32. doi: 10.1172/JCI58109. Epub 2011 Jun 1.
PubMed 21633181Suez J, Korem T, Zeevi D, Zilberman-Schapira G, Thaiss CA, Maza O, Israeli D, Zmora N, Gilad S, Weinberger A, Kuperman Y, Harmelin A, Kolodkin-Gal I, Shapiro H, Halpern Z, Segal E, Elinav E. Artificial sweeteners induce glucose intolerance by altering the gut microbiota. Nature. 2014 Oct 9;514(7521):181-6. doi: 10.1038/nature13793. Epub 2014 Sep 17.
PubMed 25231862Saccharin and its salts. IARC Monogr Eval Carcinog Risks Hum. 1999;73:517-624. No abstract available.
PubMed 10804968Pantarotto C, Salmona M, Garattini S. Plasma kinetics and urinary elimination of saccharin in man. Toxicol Lett. 1981 Dec;9(4):367-71. doi: 10.1016/0378-4274(81)90012-6.
PubMed 7330898Sweatman TW, Renwick AG. The tissue distribution and pharmacokinetics of saccharin in the rat. Toxicol Appl Pharmacol. 1980 Aug;55(1):18-31. doi: 10.1016/0041-008x(80)90215-x. No abstract available.
PubMed 7191585Renwick AG. The metabolism of intense sweeteners. Xenobiotica. 1986 Oct-Nov;16(10-11):1057-71. doi: 10.3109/00498258609038983.
PubMed 3541395Arnold DL, Krewski D, Munro IC. Saccharin: a toxicological and historical perspective. Toxicology. 1983 Jul-Aug;27(3-4):179-256. doi: 10.1016/0300-483x(83)90021-5.
PubMed 6353664Sweatman TW, Renwick AG, Burgess CD. The pharmacokinetics of saccharin in man. Xenobiotica. 1981 Aug;11(8):531-40. doi: 10.3109/00498258109045864.
PubMed 7303723Renwick AG. The disposition of saccharin in animals and man--a review. Food Chem Toxicol. 1985 Apr-May;23(4-5):429-35. doi: 10.1016/0278-6915(85)90136-x.
PubMed 3891556Evaluation of certain food additives and contaminants. Forty-first report of the Joint FAO/WHO Expert Committee on Food Additives. World Health Organ Tech Rep Ser. 1993;837:1-53. No abstract available.
PubMed 8266711Food and Agriculture Organization World Health Organization. Evaluation of certain food additives. Fifty-ninth report of the Joint FAO/WHO Expert Committee on Food Additives. World Health Organ Tech Rep Ser. 2002;913:i-viii, 1-153, back cover.
PubMed 12677645Serrano J, Smith KR, Crouch AL, Sharma V, Yi F, Vargova V, LaMoia TE, Dupont LM, Serna V, Tang F, Gomes-Dias L, Blakeslee JJ, Hatzakis E, Peterson SN, Anderson M, Pratley RE, Kyriazis GA. High-dose saccharin supplementation does not induce gut microbiota changes or glucose intolerance in healthy humans and mice. Microbiome. 2021 Jan 12;9(1):11. doi: 10.1186/s40168-020-00976-w.
PubMed 33431052
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactions of Human Gut Microbiota With Intestinal Sweet Taste Receptors
- ClinicalTrials.gov ID
- NCT03032640
- Acronym / sponsor ID
- ISTAR-micro / TRIMDFH 982524
- Conditions
- Obesity
- Keywords
- Glucose, Sweet taste receptors, Artificial sweeteners
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Study start
- 26 Jan 2017 (actual)
- Primary completion
- 21 Mar 2018 (actual)
- Study completion
- 18 Oct 2022 (actual)
- First posted
- 26 Jan 2017 (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 purpose of this study is to collect data to examine whether short-term consumption of non-caloric artificial sweeteners (NCASs), such as saccharin, can lead to changes in blood sugar levels and in the composition of the bacteria in the large intestine.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1- Healthy Lean subjects | Active comparator | Other: Oral Glucose Tolerance Test (OGTT), Other: Assessment of dietary compliance, Other: Stool sampling, Other: Sodium SaccharinGroup 1 will receive Sodium Saccharin 200mg capsule, 2x/day, Day 1-14 |
| Group 2- Healthy Lean subjects | Active comparator | Other: Oral Glucose Tolerance Test (OGTT), Other: Assessment of dietary compliance, Other: Stool sampling, Other: PlaceboGroup 2 will receive Placebo 500mg capsule, 2x/day, Day 1-14 |
| Group 3- Healthy Lean subjects | Active comparator | Other: Oral Glucose Tolerance Test (OGTT), Other: Assessment of dietary compliance, Other: Stool sampling, Other: Sodium Saccharin, Other: LactisoleGroup 3 will receive Sodium Saccharin 200mg + lactisole 335mg capsule, 2x/day, Day 1-14 |
| Group 4- Healthy Lean subjects | Active comparator | Other: Oral Glucose Tolerance Test (OGTT), Other: Assessment of dietary compliance, Other: Stool sampling, Other: LactisoleGroup 4 will receive Lactisole 335mg capsule, 2x/day, Day 1-14 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Able to provide written informed consent
- Age 18-45 years
- Weight stable (± 3 kg) during the 6 months prior to enrollment
- BMI ≤ 25 kg/m2
- Consumption of less than a can of diet beverage or a spoonful of NCASs weekly (or each equivalent from foods) during the past month
Key exclusion criteria (25 listed)
- Known coronary artery disease, angina or congestive heart failure
- Type 1 or Type 2 Diabetes (A1c ≥6.5%)
- Bleeding disorders
- Hemoglobin level < 12.5 g/dL for women; hemoglobin level < 13.0 g/dL for men
- Acute or chronic infections
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 |
|---|---|---|
| Oral Glucose Tolerance Test (OGTT)Once we test the fasting plasma glucose (after an overnight fast), subject will receive a 75g glucose beverage they will have to drink within 5 minutes. Then after drinking the beverage, 8 blood samples will be collected through the IV catheter, over the next 3 hours. | Other | Group 1- Healthy Lean subjects, Group 2- Healthy Lean subjects, Group 3- Healthy Lean subjects, Group 4- Healthy Lean subjects |
| Assessment of dietary complianceAssessment of consumption of non-caloric artificial sweeteners | Other | Group 1- Healthy Lean subjects, Group 2- Healthy Lean subjects, Group 3- Healthy Lean subjects, Group 4- Healthy Lean subjects |
| Stool samplingSubjects will provide a stool sample. | Other | Group 1- Healthy Lean subjects, Group 2- Healthy Lean subjects, Group 3- Healthy Lean subjects, Group 4- Healthy Lean subjects |
| Sodium SaccharinSubjects in group 1 and group 3 will be provided with sodium saccharin. | Other | Group 1- Healthy Lean subjects, Group 3- Healthy Lean subjects |
| PlaceboSubjects in group 2 will be provided with placebo. | Other | Group 2- Healthy Lean subjects |
| LactisoleSubjects in group 3 and group 4 will be provided with lactisole. | Other | Group 3- Healthy Lean subjects, Group 4- Healthy Lean subjects |
Primary outcome
Blood analyzed by way of NOVA StatStrip Meter and Milliplex Map Kit.
Time frame: 6 weeks
1 secondary outcome
Short chain fatty acid analyses
Time frame: 6 weeks
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 2 Feb 2023.
- Background: PubMed 23850261Swithers SE. Artificial sweeteners produce the counterintuitive effect of inducing metabolic derangements. Trends Endocrinol Metab. 2013 Sep;24(9):431-41. doi: 10.1016/j.tem.2013.05.005. Epub 2013 Jul 10.
- Background: PubMed 21633181Tilg H, Kaser A. Gut microbiome, obesity, and metabolic dysfunction. J Clin Invest. 2011 Jun;121(6):2126-32. doi: 10.1172/JCI58109. Epub 2011 Jun 1.
- Background: PubMed 25231862Suez J, Korem T, Zeevi D, Zilberman-Schapira G, Thaiss CA, Maza O, Israeli D, Zmora N, Gilad S, Weinberger A, Kuperman Y, Harmelin A, Kolodkin-Gal I, Shapiro H, Halpern Z, Segal E, Elinav E. Artificial sweeteners induce glucose intolerance by altering the gut microbiota. Nature. 2014 Oct 9;514(7521):181-6. doi: 10.1038/nature13793. Epub 2014 Sep 17.
- Background: PubMed 10804968Saccharin and its salts. IARC Monogr Eval Carcinog Risks Hum. 1999;73:517-624. No abstract available.
- Background: PubMed 7330898Pantarotto C, Salmona M, Garattini S. Plasma kinetics and urinary elimination of saccharin in man. Toxicol Lett. 1981 Dec;9(4):367-71. doi: 10.1016/0378-4274(81)90012-6.
- Background: PubMed 7191585Sweatman TW, Renwick AG. The tissue distribution and pharmacokinetics of saccharin in the rat. Toxicol Appl Pharmacol. 1980 Aug;55(1):18-31. doi: 10.1016/0041-008x(80)90215-x. No abstract available.
- Background: PubMed 3541395Renwick AG. The metabolism of intense sweeteners. Xenobiotica. 1986 Oct-Nov;16(10-11):1057-71. doi: 10.3109/00498258609038983.
- Background: PubMed 6353664Arnold DL, Krewski D, Munro IC. Saccharin: a toxicological and historical perspective. Toxicology. 1983 Jul-Aug;27(3-4):179-256. doi: 10.1016/0300-483x(83)90021-5.
- Background: PubMed 7303723Sweatman TW, Renwick AG, Burgess CD. The pharmacokinetics of saccharin in man. Xenobiotica. 1981 Aug;11(8):531-40. doi: 10.3109/00498258109045864.
- Background: PubMed 3891556Renwick AG. The disposition of saccharin in animals and man--a review. Food Chem Toxicol. 1985 Apr-May;23(4-5):429-35. doi: 10.1016/0278-6915(85)90136-x.
- Background: PubMed 8266711Evaluation of certain food additives and contaminants. Forty-first report of the Joint FAO/WHO Expert Committee on Food Additives. World Health Organ Tech Rep Ser. 1993;837:1-53. No abstract available.
- Background: PubMed 12677645Food and Agriculture Organization World Health Organization. Evaluation of certain food additives. Fifty-ninth report of the Joint FAO/WHO Expert Committee on Food Additives. World Health Organ Tech Rep Ser. 2002;913:i-viii, 1-153, back cover.
- Individual participant dataSharing planned: No
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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.
Richard Pratley, MD principal investigator
Translational Research Institute for Metabolism and Diabetes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Glucose Tolerance Test (OGTT), Assessment of dietary compliance and Stool sampling in people with Obesity, run by AdventHealth Translational Research Institute 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 5 inclusion and 25 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 2 Feb 2023. 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?
Blood analyzed by way of NOVA StatStrip Meter and Milliplex Map Kit. (time frame: 6 weeks). 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 NCT03032640, which also lists 13 linked publications.
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 2 Feb 2023.