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

AdventHealth Translational Research Institute

Status: Completed

Conditions: Obesity

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03032640

TRIMDFH 982524

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 4 patient groups

Group 1- Healthy Lean subjects

Active Comparator group

Description:

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

Treatment:

Other: Oral Glucose Tolerance Test (OGTT)

Other: Sodium Saccharin

Other: Assessment of dietary compliance

Other: Stool sampling

Group 2- Healthy Lean subjects

Active Comparator group

Description:

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

Treatment:

Other: Oral Glucose Tolerance Test (OGTT)

Other: Assessment of dietary compliance

Other: Placebo

Other: Stool sampling

Group 3- Healthy Lean subjects

Active Comparator group

Description:

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

Treatment:

Other: Oral Glucose Tolerance Test (OGTT)

Other: Sodium Saccharin

Other: Lactisole

Other: Assessment of dietary compliance

Other: Stool sampling

Group 4- Healthy Lean subjects

Active Comparator group

Description:

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

Treatment:

Other: Oral Glucose Tolerance Test (OGTT)

Other: Lactisole

Other: Assessment of dietary compliance

Other: Stool sampling