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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1- Healthy Lean subjects | Active Comparator | Group 1 will receive Sodium Saccharin 200mg capsule, 2x/day, Day 1-14 |
|
| Group 2- Healthy Lean subjects | Active Comparator | Group 2 will receive Placebo 500mg capsule, 2x/day, Day 1-14 |
|
| Group 3- Healthy Lean subjects | Active Comparator | Group 3 will receive Sodium Saccharin 200mg + lactisole 335mg capsule, 2x/day, Day 1-14 |
|
| Group 4- Healthy Lean subjects | Active Comparator | Group 4 will receive Lactisole 335mg capsule, 2x/day, Day 1-14 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood analyzed by way of NOVA StatStrip Meter and Milliplex Map Kit. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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
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)
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| Name | Affiliation | Role |
|---|---|---|
| Richard Pratley, MD | Translational Research Institute for Metabolism and Diabetes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Translational Research Institute for Metabolism and Diabetes | Orlando | Florida | 32804 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23850261 | Background | 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. | |
| 21633181 | Background | 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. |
| Label | URL |
|---|---|
| Website for Translational Research Institute for Metabolism and Diabetes | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005951 | Glucose Tolerance Test |
| D012439 | Saccharin |
| C495512 | lactisole |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Assessment of dietary compliance | Other | Assessment of consumption of non-caloric artificial sweeteners |
|
| Stool sampling | Other | Subjects will provide a stool sample. |
|
| Sodium Saccharin | Other | Subjects in group 1 and group 3 will be provided with sodium saccharin. |
|
| Placebo | Other | Subjects in group 2 will be provided with placebo. |
|
| Lactisole | Other | Subjects in group 3 and group 4 will be provided with lactisole. |
|
| 25231862 | Background | 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. |
| 10804968 | Background | Saccharin and its salts. IARC Monogr Eval Carcinog Risks Hum. 1999;73:517-624. No abstract available. |
| 7330898 | Background | 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. |
| 7191585 | Background | 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. |
| 3541395 | Background | Renwick AG. The metabolism of intense sweeteners. Xenobiotica. 1986 Oct-Nov;16(10-11):1057-71. doi: 10.3109/00498258609038983. |
| 6353664 | Background | 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. |
| 7303723 | Background | Sweatman TW, Renwick AG, Burgess CD. The pharmacokinetics of saccharin in man. Xenobiotica. 1981 Aug;11(8):531-40. doi: 10.3109/00498258109045864. |
| 3891556 | Background | 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. |
| 8266711 | Background | 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. |
| 12677645 | Background | 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. |
| 33431052 | Derived | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D052160 | Benzothiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |