Interactions of Human Gut Microbiota With Intestinal Sweet Taste Receptors

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: Oral Glucose Tolerance Test (OGTT); Other: Assessment of dietary compliance; Other: Stool sampling; Other: Sodium Saccharin; Other: Placebo; Other: Lactisole

• Registration Number: NCT03032640
• Lead Sponsor: AdventHealth Translational Research Institute

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 available

Study Timeline

• Study First Submitted: 2016-11-11
• Study First Submitted QC: 2017-01-25
• Study Start: 2017-01-26
• Study First Posted: 2017-01-26
• Primary Completion: 2018-03-21
• Study Completion: 2022-10-18
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2- Healthy Lean subjects	Oral Glucose Tolerance Test (OGTT)	Group 2 will receive Placebo 500mg capsule, 2x/day, Day 1-14
Group 1- Healthy Lean subjects	Sodium Saccharin	Group 1 will receive Sodium Saccharin 200mg capsule, 2x/day, Day 1-14
Group 2- Healthy Lean subjects	Assessment of dietary compliance	Group 2 will receive Placebo 500mg capsule, 2x/day, Day 1-14
Group 3- Healthy Lean subjects	Stool sampling	Group 3 will receive Sodium Saccharin 200mg + lactisole 335mg capsule, 2x/day, Day 1-14
Group 4- Healthy Lean subjects	Oral Glucose Tolerance Test (OGTT)	Group 4 will receive Lactisole 335mg capsule, 2x/day, Day 1-14
Group 4- Healthy Lean subjects	Assessment of dietary compliance	Group 4 will receive Lactisole 335mg capsule, 2x/day, Day 1-14
Group 1- Healthy Lean subjects	Oral Glucose Tolerance Test (OGTT)	Group 1 will receive Sodium Saccharin 200mg capsule, 2x/day, Day 1-14
Group 3- Healthy Lean subjects	Assessment of dietary compliance	Group 3 will receive Sodium Saccharin 200mg + lactisole 335mg capsule, 2x/day, Day 1-14
Group 3- Healthy Lean subjects	Lactisole	Group 3 will receive Sodium Saccharin 200mg + lactisole 335mg capsule, 2x/day, Day 1-14
Group 1- Healthy Lean subjects	Assessment of dietary compliance	Group 1 will receive Sodium Saccharin 200mg capsule, 2x/day, Day 1-14
Group 1- Healthy Lean subjects	Stool sampling	Group 1 will receive Sodium Saccharin 200mg capsule, 2x/day, Day 1-14
Group 2- Healthy Lean subjects	Placebo	Group 2 will receive Placebo 500mg capsule, 2x/day, Day 1-14
Group 4- Healthy Lean subjects	Lactisole	Group 4 will receive Lactisole 335mg capsule, 2x/day, Day 1-14
Group 4- Healthy Lean subjects	Stool sampling	Group 4 will receive Lactisole 335mg capsule, 2x/day, Day 1-14
Group 2- Healthy Lean subjects	Stool sampling	Group 2 will receive Placebo 500mg capsule, 2x/day, Day 1-14
Group 3- Healthy Lean subjects	Oral Glucose Tolerance Test (OGTT)	Group 3 will receive Sodium Saccharin 200mg + lactisole 335mg capsule, 2x/day, Day 1-14
Group 3- Healthy Lean subjects	Sodium Saccharin	Group 3 will receive Sodium Saccharin 200mg + lactisole 335mg capsule, 2x/day, Day 1-14

Primary Outcome Measures

Name	Time	Method
Blood analyzed by way of NOVA StatStrip Meter and Milliplex Map Kit.	6 weeks

Secondary Outcome Measures

Name	Time	Method
Short chain fatty acid analyses	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.

Trial Locations

Locations (1)

Translational Research Institute for Metabolism and Diabetes; 🇺🇸 Orlando, Florida, United States