Obesity
Conditions
Keywords
Glucose, Sweet taste receptors, Artificial sweeteners
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.
Interventions
OTHEROral 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.
OTHERAssessment of dietary compliance
Assessment of consumption of non-caloric artificial sweeteners
OTHERStool sampling
Subjects will provide a stool sample.
OTHERSodium Saccharin
Subjects in group 1 and group 3 will be provided with sodium saccharin.
OTHERPlacebo
Subjects in group 2 will be provided with placebo.
OTHERLactisole
Subjects in group 3 and group 4 will be provided with lactisole.
Sponsors
AdventHealth Translational Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood analyzed by way of NOVA StatStrip Meter and Milliplex Map Kit. | 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed