ISTAR-micro: Interactions of Human Gut Microbiota With Intestinal Sweet Taste Receptors
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group 1- Healthy Lean subjects Group 1 will receive Sodium Saccharin 200mg capsule, 2x/day, Day 1-14 |
Other: 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: Assessment of dietary compliance
Assessment of consumption of non-caloric artificial sweeteners
Other: Stool sampling
Subjects will provide a stool sample.
Other: Sodium Saccharin
Subjects in group 1 and group 3 will be provided with sodium saccharin.
|
| Active Comparator: Group 2- Healthy Lean subjects Group 2 will receive Placebo 500mg capsule, 2x/day, Day 1-14 |
Other: 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: Assessment of dietary compliance
Assessment of consumption of non-caloric artificial sweeteners
Other: Stool sampling
Subjects will provide a stool sample.
Other: Placebo
Subjects in group 2 will be provided with placebo.
|
| Active Comparator: Group 3- Healthy Lean subjects Group 3 will receive Sodium Saccharin 200mg + lactisole 335mg capsule, 2x/day, Day 1-14 |
Other: 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: Assessment of dietary compliance
Assessment of consumption of non-caloric artificial sweeteners
Other: Stool sampling
Subjects will provide a stool sample.
Other: Sodium Saccharin
Subjects in group 1 and group 3 will be provided with sodium saccharin.
Other: Lactisole
Subjects in group 3 and group 4 will be provided with lactisole.
|
| Active Comparator: Group 4- Healthy Lean subjects Group 4 will receive Lactisole 335mg capsule, 2x/day, Day 1-14 |
Other: 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: Assessment of dietary compliance
Assessment of consumption of non-caloric artificial sweeteners
Other: Stool sampling
Subjects will provide a stool sample.
Other: Lactisole
Subjects in group 3 and group 4 will be provided with lactisole.
|
Outcome Measures
Primary Outcome Measures
- Blood analyzed by way of NOVA StatStrip Meter and Milliplex Map Kit. [6 weeks]
Secondary Outcome Measures
- Short chain fatty acid analyses [6 weeks]
Stool sample aliquoted and frozen by way of ribosomal sequencing, which will be used to determine what bacteria is in the fecal sample.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
Known coronary artery disease, angina or congestive heart failure
-
Type 1 or Type 2 Diabetes (A1c ≥6.5%)
-
Bleeding disorders
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Hemoglobin level < 12.5 g/dL for women; hemoglobin level < 13.0 g/dL for men
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Acute or chronic infections
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Hepatitis and/or cirrhosis
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Severe asthma or chronic obstructive pulmonary disease
-
Renal insufficiency or nephritis (creatinine > 1.6 mg/dl)
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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)
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Psychiatric disorders or eating disorders
-
Cushing's disease or syndrome
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Untreated or inadequately controlled hypo- or hyperthyroidism (abnormal TSH)
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Active rheumatoid arthritis or other inflammatory rheumatic disorder
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Pregnant or nursing women
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Smoking (smoking within the past 3 months)
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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
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Oral, injected or chronic topical steroids (inhaled steroids for mild asthma are acceptable)
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Antibiotic use (within the past 3 months)
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Other drugs known to affect immune or metabolic function
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Orlistat, phentermine, topiramate or other weight loss or anorectic agents (tricyclic antidepressants, atypical antipsychotics or other psychiatric drugs with effects on body weight)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Translational Research Institute for Metabolism and Diabetes | Orlando | Florida | United States | 32804 |
Sponsors and Collaborators
- AdventHealth Translational Research Institute
Investigators
- Principal Investigator: Richard Pratley, MD, Translational Research Institute for Metabolism and Diabetes
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Arnold DL, Krewski D, Munro IC. Saccharin: a toxicological and historical perspective. Toxicology. 1983 Jul-Aug;27(3-4):179-256. Review.
- 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.
- 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.
- Pantarotto C, Salmona M, Garattini S. Plasma kinetics and urinary elimination of saccharin in man. Toxicol Lett. 1981 Dec;9(4):367-71.
- Renwick AG. The disposition of saccharin in animals and man--a review. Food Chem Toxicol. 1985 Apr-May;23(4-5):429-35. Review.
- Renwick AG. The metabolism of intense sweeteners. Xenobiotica. 1986 Oct-Nov;16(10-11):1057-71. Review.
- Saccharin and its salts. IARC Monogr Eval Carcinog Risks Hum. 1999;73:517-624. Review.
- 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.
- Sweatman TW, Renwick AG, Burgess CD. The pharmacokinetics of saccharin in man. Xenobiotica. 1981 Aug;11(8):531-40.
- Sweatman TW, Renwick AG. The tissue distribution and pharmacokinetics of saccharin in the rat. Toxicol Appl Pharmacol. 1980 Aug;55(1):18-31.
- 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. Review.
- TRIMDFH 982524