Diabetes
Conditions
Keywords
Obesity, sweet taste receptors
Brief summary
The purpose of this study is to collect data that will help researchers better understand the various causes of obesity and diabetes; particularly to understand how consumption of NCASs affects the way the body uses nutrients.
Interventions
OTHERDietary: saccharin
Assess the glycemic and hormonal responses to an oral glucose load preceded by an oral solution of NCASs (saccharin).
OTHEREstimate glucose absorptions
Indirectly estimate the rate of glucose absorption and gastric emptying by using 3-O-methyglucose (3-OMG) and acetaminophen, respectively.
Sponsors
Sanford-Burnham Medical Research Institute
AdventHealth Translational Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18-65 years inclusive; 2. Men and women; 3. Able to provide written, informed consent; 4. Weight stable (± 3 kg) during the 3 months prior to enrollment; 5. BMI ≤ 25 kg/m2
Exclusion criteria
1. Diagnosed with any of the following co-morbidities: a) coronary artery disease, angina or heart failure, b) diabetes, c) bleeding disorders, d) infections, e) hepatitis and/or cirrhosis, f) severe asthma or chronic obstructive pulmonary disorder, g) renal insufficiency, h) bariatric surgery, i) inflammatory bowel disease or malabsorption, j) cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ), k) psychiatric or eating disorders, l) untreated or inadequately controlled thyroid or other endocrine disorders, m) active rheumatoid arthritis or other inflammatory rheumatic disorder; 2. Consumption of more than a can of diet beverage or a spoonful of non-caloric artificial sweeteners weekly (or each equivalent from foods) during the past month. 3. Pregnant or nursing women; 4. Current smokers (smoking within the past 3 months); 5. Known hypersensitivity to saccharin, lactisole, and acetaminophen or any of its exipients; 6. History of difficult blood sample collections or unfavorable anatomy of venous access; 7. Use of medications: a) nitrates, b) beta-blockers, c) digoxin, d) anti-diabetic agents, e) oral, injected or chronic topical steroids (inhaled steroids for mild asthma are acceptable), f) chronic use of aspirin or other non-steroidal anti-inflammatory drugs, g) other drugs known to affect immune or metabolic function and h) orlistat, phentermine or other weight loss or anorectic agents. 8. Blood pressure greater than or equal to 160/100 or less than or equal to 100/50 at screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure in glucose concentrations | Measure over a 180 minute on Days 10, 15, 20, 25 | Glucose concentrations will be measured by the glucose oxidase method (YSI 2300 automated analyzer) and insulin, C-peptide, GLP-1 and GLP-2 concentrations by immunoassay (Mesoscale Discovery Sector Imager 2400). |
Countries
United States
Outcome results
None listed