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

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Other: Estimate glucose absorptions

• Registration Number: NCT02835859
• Lead Sponsor: AdventHealth Translational Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2016-01
• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2016-07-13
• Study First Posted: 2016-07-18
• Study Completion: 2017-09
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-12
• Last Update Posted: 2020-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1- Oral solution	Estimate glucose absorptions	Participants will be randomly assigned to drink two oral solutions made of different combinations of saccharin, lactisole, acetaminophen, 3-O-methyl glucose, or glucose.

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Translational Research Institute for Metabolism and Diabetes; 🇺🇸 Orlando, Florida, United States