NCT03032640

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

January 26, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2018

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2022

Completed
Last Updated

February 2, 2023

Status Verified

February 1, 2023

Enrollment Period

1.1 years

First QC Date

November 11, 2016

Last Update Submit

February 1, 2023

Conditions

Obesity

Keywords

GlucoseSweet taste receptorsArtificial sweeteners

Outcome Measures

Primary Outcomes (1)

  • Blood analyzed by way of NOVA StatStrip Meter and Milliplex Map Kit.

    6 weeks

Secondary Outcomes (1)

  • Short chain fatty acid analyses

    6 weeks

Study Arms (4)

Group 1- Healthy Lean subjects

ACTIVE COMPARATOR

Group 1 will receive Sodium Saccharin 200mg capsule, 2x/day, Day 1-14

Other: Oral Glucose Tolerance Test (OGTT)Other: Assessment of dietary complianceOther: Stool samplingOther: Sodium Saccharin

Group 2- Healthy Lean subjects

ACTIVE COMPARATOR

Group 2 will receive Placebo 500mg capsule, 2x/day, Day 1-14

Other: Oral Glucose Tolerance Test (OGTT)Other: Assessment of dietary complianceOther: Stool samplingOther: Placebo

Group 3- Healthy Lean subjects

ACTIVE COMPARATOR

Group 3 will receive Sodium Saccharin 200mg + lactisole 335mg capsule, 2x/day, Day 1-14

Other: Oral Glucose Tolerance Test (OGTT)Other: Assessment of dietary complianceOther: Stool samplingOther: Sodium SaccharinOther: Lactisole

Group 4- Healthy Lean subjects

ACTIVE COMPARATOR

Group 4 will receive Lactisole 335mg capsule, 2x/day, Day 1-14

Other: Oral Glucose Tolerance Test (OGTT)Other: Assessment of dietary complianceOther: Stool samplingOther: Lactisole

Interventions

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.

Group 1- Healthy Lean subjectsGroup 2- Healthy Lean subjectsGroup 3- Healthy Lean subjectsGroup 4- Healthy Lean subjects
Assessment of dietary complianceOTHER

Assessment of consumption of non-caloric artificial sweeteners

Group 1- Healthy Lean subjectsGroup 2- Healthy Lean subjectsGroup 3- Healthy Lean subjectsGroup 4- Healthy Lean subjects
Stool samplingOTHER

Subjects will provide a stool sample.

Group 1- Healthy Lean subjectsGroup 2- Healthy Lean subjectsGroup 3- Healthy Lean subjectsGroup 4- Healthy Lean subjects
Sodium SaccharinOTHER

Subjects in group 1 and group 3 will be provided with sodium saccharin.

Group 1- Healthy Lean subjectsGroup 3- Healthy Lean subjects
PlaceboOTHER

Subjects in group 2 will be provided with placebo.

Group 2- Healthy Lean subjects
LactisoleOTHER

Subjects in group 3 and group 4 will be provided with lactisole.

Group 3- Healthy Lean subjectsGroup 4- Healthy Lean subjects

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, United States

Location

Related Publications (13)

  • 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.

    PMID: 23850261BACKGROUND

  • 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.

    PMID: 21633181BACKGROUND

  • 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.

    PMID: 25231862BACKGROUND

  • Saccharin and its salts. IARC Monogr Eval Carcinog Risks Hum. 1999;73:517-624. No abstract available.

    PMID: 10804968BACKGROUND

  • 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.

    PMID: 7330898BACKGROUND

  • 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.

    PMID: 7191585BACKGROUND

  • Renwick AG. The metabolism of intense sweeteners. Xenobiotica. 1986 Oct-Nov;16(10-11):1057-71. doi: 10.3109/00498258609038983.

    PMID: 3541395BACKGROUND

  • 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.

    PMID: 6353664BACKGROUND

  • Sweatman TW, Renwick AG, Burgess CD. The pharmacokinetics of saccharin in man. Xenobiotica. 1981 Aug;11(8):531-40. doi: 10.3109/00498258109045864.

    PMID: 7303723BACKGROUND

  • 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.

    PMID: 3891556BACKGROUND

  • 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.

    PMID: 8266711BACKGROUND

  • 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.

    PMID: 12677645BACKGROUND

  • 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.

    PMID: 33431052DERIVED

Related Links

MeSH Terms

Conditions

Obesity

Interventions

Glucose Tolerance TestSaccharinlactisole

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative TechniquesThiazolesSulfur CompoundsOrganic ChemicalsBenzothiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Richard Pratley, MD

    Translational Research Institute for Metabolism and Diabetes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2016

First Posted

January 26, 2017

Study Start

January 26, 2017

Primary Completion

March 21, 2018

Study Completion

October 18, 2022

Last Updated

February 2, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)