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OpenTrials
Completed

NCT Number: NCT02835859

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary: saccharin

Other

Assess the glycemic and hormonal responses to an oral glucose load preceded by an oral solution of NCASs (saccharin).

Estimate glucose absorptions

Other

Indirectly estimate the rate of glucose absorption and gastric emptying by using 3-O-methyglucose (3-OMG) and acetaminophen, respectively.

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

AdventHealth Translational Research Institute

Other

Collaborators

  • Sanford-Burnham Medical Research Institute

Registry information

Acronym: ISTAR

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jul 18, 2016
Registry last updated
Aug 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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