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Interactions of Human Gut Microbiota With Intestinal Sweet Taste Receptors (ISTAR-micro)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032640
Recruitment Status : Active, not recruiting
First Posted : January 26, 2017
Last Update Posted : March 19, 2021
Sponsor:
Information provided by (Responsible Party):
Translational Research Institute for Metabolism and Diabetes, Florida

Tracking Information
First Submitted Date  ICMJE November 11, 2016
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date March 19, 2021
Actual Study Start Date  ICMJE January 26, 2017
Actual Primary Completion Date March 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
Blood analyzed by way of NOVA StatStrip Meter and Milliplex Map Kit. [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
Short chain fatty acid analyses [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interactions of Human Gut Microbiota With Intestinal Sweet Taste Receptors
Official Title  ICMJE Interactions of Human Gut Microbiota With Intestinal Sweet Taste Receptors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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: Placebo
    Subjects in group 2 will be provided with placebo.
  • Other: Lactisole
    Subjects in group 3 and group 4 will be provided with lactisole.
Study Arms  ICMJE
  • Active Comparator: Group 1- Healthy Lean subjects
    Group 1 will receive Sodium Saccharin 200mg capsule, 2x/day, Day 1-14
    Interventions:
    • Other: Oral Glucose Tolerance Test (OGTT)
    • Other: Assessment of dietary compliance
    • Other: Stool sampling
    • Other: Sodium Saccharin
  • Active Comparator: Group 2- Healthy Lean subjects
    Group 2 will receive Placebo 500mg capsule, 2x/day, Day 1-14
    Interventions:
    • Other: Oral Glucose Tolerance Test (OGTT)
    • Other: Assessment of dietary compliance
    • Other: Stool sampling
    • Other: Placebo
  • Active Comparator: Group 3- Healthy Lean subjects
    Group 3 will receive Sodium Saccharin 200mg + lactisole 335mg capsule, 2x/day, Day 1-14
    Interventions:
    • Other: Oral Glucose Tolerance Test (OGTT)
    • Other: Assessment of dietary compliance
    • Other: Stool sampling
    • Other: Sodium Saccharin
    • Other: Lactisole
  • Active Comparator: Group 4- Healthy Lean subjects
    Group 4 will receive Lactisole 335mg capsule, 2x/day, Day 1-14
    Interventions:
    • Other: Oral Glucose Tolerance Test (OGTT)
    • Other: Assessment of dietary compliance
    • Other: Stool sampling
    • Other: Lactisole
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2017)
90
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Actual Primary Completion Date March 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Able to provide written informed consent
  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:

  1. Known coronary artery disease, angina or congestive heart failure
  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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03032640
Other Study ID Numbers  ICMJE TRIMDFH 982524
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Translational Research Institute for Metabolism and Diabetes, Florida
Study Sponsor  ICMJE Translational Research Institute for Metabolism and Diabetes, Florida
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard Pratley, MD Translational Research Institute for Metabolism and Diabetes
PRS Account Translational Research Institute for Metabolism and Diabetes, Florida
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP