CompletedPhase 1/2

Metabolic Effects of Non-Nutritive Sweeteners

United States118 participantsStarted 2010-11-04

Plain-language 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 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.

Who can participate

Age range

6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

GLP-1 secretion change with sucralose

Timeframe: At minute -10,0,10, 20,30,60,90,120

Trial details

NCT IDNCT01200940

SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2017-03-02

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