Metabolic Effects of Non-Nutritive Sweeteners
Completed · Phase 1/Phase 2
Conditions studied: Healthy Volunteers
In brief
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 affect hormones in the body, especially when they are consumed in combination with real sugar. Changes in hormone levels may, in turn, result in changes in blood sugar, appetite, and weight. Researchers are interested in studying the effects of artificial sweeteners on the metabolism and hormonal levels of healthy volunteers. Objectives: * To study the effects that artificial sweeteners have on hormone levels, blood sugar, and appetite. * To evaluate whether artificial sweeteners change the rate at which food passes out of the stomach into the gut, or the rate at which the body absorbs sugar from the gut. * To evaluate the effects that different amounts of artificial sweeteners have on hormone levels. Eligibility: \- Healthy volunteers between 18 and 45 years of age. Design: * This study will require one screening visit and four testing visits, scheduled on different days. * At the screening visit, eligible participants will be screened with a physical examination, medical history, blood samples, and body measurements (including height, weight, body circumferences, and skin folds). Participants will also be asked about how much artificial sweetener they typically consume and will have taste tests, in which a small amount of flavored liquid is placed on the tongue and participants will name the flavor and rate its intensity. * Participants will have four glucose tolerance tests on four different days. In preparation for the test, participants will not eat or drink anything but water for 12 hours prior to the test. Blood will be drawn before the test, and participants will drink one of the following study liquids, selected at random: * Plain water * Water mixed with sucralose (the amount found in one 12 oz diet soft drink) * Water mixed with sucralose (the amount found in 2.5 12 oz diet soft drinks) * Water mixed with sucralose (the amount found in 3.7 12 oz diet soft drinks) * Ten minutes after drinking the study liquid, participants will have a sugary drink that will allow researchers to measure sugar absorption and the speed with which food leaves the stomach. * In addition, participants will complete questionnaires about hunger levels before drinking the sugar solution and at regular intervals for 2 hours afterward. Blood samples will be taken at regular intervals as well.
Key facts
- Study ID
- NCT01200940
- Run by
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- People needed
- 118
- Starts
- 2010-11-04
- Expected to finish
- 2017-03-30
- Last updated by the study team
- 2021-01-22
Who can join
Age: 6 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age greater than or equal to 18 years
- No known active medical conditions
You may not qualify if…
- 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
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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