Intestinal Sweet Taste Receptor Function and Adaptation to Dietary Sugars and Sweeteners
This trial is active, not recruiting.
|Treatments||dietary: saccharin, estimate glucose absorptions|
|Sponsor||Translational Research Institute for Metabolism and Diabetes, Florida|
|Collaborator||Sanford-Burnham Medical Research Institute|
|Start date||August 2014|
|End date||January 2017|
|Trial size||20 participants|
|Trial identifier||NCT02835859, TRIMD FH 607060|
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.
|Endpoint classification||pharmacokinetics study|
|Intervention model||single group assignment|
|Primary purpose||basic science|
Measure in glucose concentrations
time frame: Measure over a 180 minute on Days 10, 15, 20, 25
Male or female participants from 18 years up to 65 years old.
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.
|Official title||Intestinal Sweet Taste Receptor Function and Adaptation to Dietary Sugars and Sweeteners|
|Principal investigator||George Kyriazis, PhD|
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