Intestinal Sweet Taste Receptor Function and Adaptation to Dietary Sugars and Sweeteners

AdventHealth Translational Research Institute1 site in 1 country10 target enrollmentAugust 2014

ConditionsDiabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes
Sponsor: AdventHealth Translational Research Institute
Enrollment: 10
Locations: 1
Primary Endpoint: Measure in glucose concentrations
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

September 2017

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AdventHealth Translational Research Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18-65 years inclusive;
•Men and women;
•Able to provide written, informed consent;
•Weight stable (± 3 kg) during the 3 months prior to enrollment;
•BMI ≤ 25 kg/m2

Exclusion Criteria

•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;
•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.
•Pregnant or nursing women;
•Current smokers (smoking within the past 3 months);
•Known hypersensitivity to saccharin, lactisole, and acetaminophen or any of its exipients;
•History of difficult blood sample collections or unfavorable anatomy of venous access;
•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.
•Blood pressure greater than or equal to 160/100 or less than or equal to 100/50 at screening.

Outcomes

Primary Outcomes

Measure in glucose concentrations

Time Frame: 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).