Interactions of Human Gut Microbiota With Intestinal Sweet Taste Receptors
NCT ID: NCT03032640
Last Updated: 2023-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
102 participants
INTERVENTIONAL
2017-01-26
2022-10-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Non-nutritive Sweeteners of High Sugar Sweetened Beverages on Metabolic Health and Gut Microbiome
NCT03259685
Effects of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism
NCT02569762
On the Impact of Common Sweetening Agents on Glucose Regulation, Cognitive Functioning and Gut Microbiota
NCT02580110
Sucralose, Stevia, Gut Microbiome and Glucose Metabolism
NCT02800707
The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adults
NCT02335021
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1- Healthy Lean subjects
Group 1 will receive Sodium Saccharin 200mg capsule, 2x/day, Day 1-14
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.
Assessment of dietary compliance
Assessment of consumption of non-caloric artificial sweeteners
Stool sampling
Subjects will provide a stool sample.
Sodium Saccharin
Subjects in group 1 and group 3 will be provided with sodium saccharin.
Group 2- Healthy Lean subjects
Group 2 will receive Placebo 500mg capsule, 2x/day, Day 1-14
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.
Assessment of dietary compliance
Assessment of consumption of non-caloric artificial sweeteners
Stool sampling
Subjects will provide a stool sample.
Placebo
Subjects in group 2 will be provided with placebo.
Group 3- Healthy Lean subjects
Group 3 will receive Sodium Saccharin 200mg + lactisole 335mg capsule, 2x/day, Day 1-14
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.
Assessment of dietary compliance
Assessment of consumption of non-caloric artificial sweeteners
Stool sampling
Subjects will provide a stool sample.
Sodium Saccharin
Subjects in group 1 and group 3 will be provided with sodium saccharin.
Lactisole
Subjects in group 3 and group 4 will be provided with lactisole.
Group 4- Healthy Lean subjects
Group 4 will receive Lactisole 335mg capsule, 2x/day, Day 1-14
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.
Assessment of dietary compliance
Assessment of consumption of non-caloric artificial sweeteners
Stool sampling
Subjects will provide a stool sample.
Lactisole
Subjects in group 3 and group 4 will be provided with lactisole.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Assessment of dietary compliance
Assessment of consumption of non-caloric artificial sweeteners
Stool sampling
Subjects will provide a stool sample.
Sodium Saccharin
Subjects in group 1 and group 3 will be provided with sodium saccharin.
Placebo
Subjects in group 2 will be provided with placebo.
Lactisole
Subjects in group 3 and group 4 will be provided with lactisole.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age 18-45 years
3. Weight stable (± 3 kg) during the 6 months prior to enrollment
4. BMI ≤ 25 kg/m2
5. Consumption of less than a can of diet beverage or a spoonful of NCASs weekly (or each equivalent from foods) during the past month
Exclusion Criteria
2. Type 1 or Type 2 Diabetes (A1c ≥6.5%)
3. Bleeding disorders
4. Hemoglobin level \< 12.5 g/dL for women; hemoglobin level \< 13.0 g/dL for men
5. Acute or chronic infections
6. Hepatitis and/or cirrhosis
7. Severe asthma or chronic obstructive pulmonary disease
8. Renal insufficiency or nephritis (creatinine \> 1.6 mg/dl)
9. Prior bariatric surgery
10. Inflammatory bowel disease or malabsorption
11. Cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ)
12. Psychiatric disorders or eating disorders
13. Cushing's disease or syndrome
14. Untreated or inadequately controlled hypo- or hyperthyroidism (abnormal TSH)
15. Active rheumatoid arthritis or other inflammatory rheumatic disorder
16. Pregnant or nursing women
17. Smoking (smoking within the past 3 months)
18. Less than 4 bowel movements per week
19. Known hypersensitivity to saccharin, lactisole or any of its excipients.
Excluded medications include but are not limited to:
20. Anti-diabetic agents
21. Oral, injected or chronic topical steroids (inhaled steroids for mild asthma are acceptable)
22. Antibiotic use (within the past 3 months)
23. Other drugs known to affect immune or metabolic function
24. Orlistat, phentermine, topiramate or other weight loss or anorectic agents (tricyclic antidepressants, atypical antipsychotics or other psychiatric drugs with effects on body weight)
18 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AdventHealth Translational Research Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Richard Pratley, MD
Role: PRINCIPAL_INVESTIGATOR
Translational Research Institute for Metabolism and Diabetes
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Tilg 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.
Suez 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.
Saccharin and its salts. IARC Monogr Eval Carcinog Risks Hum. 1999;73:517-624. No abstract available.
Pantarotto 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.
Sweatman 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.
Renwick AG. The metabolism of intense sweeteners. Xenobiotica. 1986 Oct-Nov;16(10-11):1057-71. doi: 10.3109/00498258609038983.
Arnold 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.
Sweatman TW, Renwick AG, Burgess CD. The pharmacokinetics of saccharin in man. Xenobiotica. 1981 Aug;11(8):531-40. doi: 10.3109/00498258109045864.
Renwick 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.
Evaluation 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.
Food 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.
Serrano 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.
Related Links
Access external resources that provide additional context or updates about the study.
Website for Translational Research Institute for Metabolism and Diabetes
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TRIMDFH 982524
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.