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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 10, 2020
Sponsor:
Information provided by (Responsible Party):
Translational Research Institute for Metabolism and Diabetes, Florida

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
Obesity Other: Oral Glucose Tolerance Test (OGTT) Other: Assessment of dietary compliance Other: Stool sampling Other: Sodium Saccharin Other: Placebo Other: Lactisole Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Interactions of Human Gut Microbiota With Intestinal Sweet Taste Receptors
Actual Study Start Date : January 26, 2017
Actual Primary Completion Date : March 21, 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Blood analyzed by way of NOVA StatStrip Meter and Milliplex Map Kit. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032640


Locations
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United States, Florida
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States, 32804
Sponsors and Collaborators
Translational Research Institute for Metabolism and Diabetes, Florida
Investigators
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Principal Investigator: Richard Pratley, MD Translational Research Institute for Metabolism and Diabetes
Additional Information:
Publications:

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Responsible Party: Translational Research Institute for Metabolism and Diabetes, Florida
ClinicalTrials.gov Identifier: NCT03032640    
Other Study ID Numbers: TRIMDFH 982524
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Translational Research Institute for Metabolism and Diabetes, Florida:
Glucose
Sweet taste receptors
Artificial sweeteners