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

February 1, 2023 updated by: AdventHealth Translational Research Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Translational Research Institute for Metabolism and Diabetes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood analyzed by way of NOVA StatStrip Meter and Milliplex Map Kit.
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth Translational Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 26, 2017

Primary Completion (ACTUAL)

March 21, 2018

Study Completion (ACTUAL)

October 18, 2022

Study Registration Dates

First Submitted

November 11, 2016

First Submitted That Met QC Criteria

January 25, 2017

First Posted (ESTIMATE)

January 26, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2023

Last Update Submitted That Met QC Criteria

February 1, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TRIMDFH 982524

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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