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

A

AdventHealth Translational Research Institute

Status

Completed

Conditions

Obesity

Treatments

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

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: Stool sampling
Other: Sodium Saccharin
Other: Oral Glucose Tolerance Test (OGTT)
Other: Assessment of dietary compliance
Group 2- Healthy Lean subjects
Active Comparator group
Description:
Group 2 will receive Placebo 500mg capsule, 2x/day, Day 1-14
Treatment:
Other: Placebo
Other: Stool sampling
Other: Oral Glucose Tolerance Test (OGTT)
Other: Assessment of dietary compliance
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: Stool sampling
Other: Sodium Saccharin
Other: Oral Glucose Tolerance Test (OGTT)
Other: Assessment of dietary compliance
Other: Lactisole
Group 4- Healthy Lean subjects
Active Comparator group
Description:
Group 4 will receive Lactisole 335mg capsule, 2x/day, Day 1-14
Treatment:
Other: Stool sampling
Other: Oral Glucose Tolerance Test (OGTT)
Other: Assessment of dietary compliance
Other: Lactisole

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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