Status:
COMPLETED
Metabolic Effects of Non-Nutritive Sweeteners
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Healthy Volunteers
Eligibility:
All Genders
6+ years
Phase:
PHASE1
PHASE2
Brief Summary
Background: \- Artificial sweeteners, such as sucralose (brand name Splenda), are very commonly found in products such as diet soft drinks. Recently, researchers learned that these sweeteners may aff...
Detailed Description
Background Consumption of non-nutritive sweeteners is common practice in the US, and these chemicals are generally thought to be metabolically inert. However, recent data obtained from animal studies...
Eligibility Criteria
Inclusion
- MAIN STUDY:
- INCLUSION CRITERIA:
- Age greater than or equal to 18 years
- No known active medical conditions
- EXCLUSION CRITERIA:
- Current use of prescription or non-prescription medication. Certain exceptions are permitted, including topical medications, vitamins, and hormonal contraceptives. Other medications may be permitted at the discretion of the investigators.
- Recent (past 2 months) use of drugs that alter glucose metabolism (e.g. metformin), alter gastric pH (e.g. proton pump inhibitors) or gastric emptying (e.g. metoclopramide)
- ALT or AST more than 1.5 times the upper limit of normal
- Positive urine pregnancy test
- Known allergy, sensitivity or other contraindication to any study food or drug or its vehicle
- Psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to provide informed consent, or to comply with study procedures
- Body weight less than 50 kg
- Diabetes (fasting blood glucose of 126 mg/dl or higher, or 2-hour blood glucose of 200 or higher on oral glucose tolerance testing)
- Glycosuria
- PEDIATRIC PILOT STUDY:
- INCLUSION CRITERIA:
- Age 6-12 years at enrollment
- Body weight at least 17 kg
- Prepubertal (Tanner stage I breasts in girls, or testicular volumes less than or equal to 3 mL in boys)
- No known active medical conditions
- EXCLUSION CRITERIA:
- Current use of prescription or non-prescription medication. Certain exceptions are permitted, including topical medications and vitamins. Other medications may be permitted at the discretion of the investigators.
- Recent (past 2 months) use of drugs that alter glucose metabolism (e.g. metformin), alter gastric pH (e.g. proton pump inhibitors) or gastric emptying (e.g. metoclopramide)
- ALT or AST more than 1.5 times the upper limit of normal
- Known allergy, sensitivity or other contraindication to any study food or drug or its vehicle
- Psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to provide assent, and/or the subject s parent/guardian to provide informed consent, or to comply with study procedures
- Abnormal glucose tolerance (fasting blood glucose of 100 mg/dl or higher, or 2-hour blood glucose of 140 or higher on oral glucose tolerance testing)
- Glycosuria
Exclusion
Key Trial Info
Start Date :
November 4 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2017
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT01200940
Start Date
November 4 2010
End Date
March 30 2017
Last Update
January 22 2021
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892