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NCT01200940 · ClinicalTrials.gov registry record · Phase 1
Metabolic Effects of Non-Nutritive Sweeteners
A Phase 1 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 1
- Development phase
- 118
- Enrollment target
NCT01200940: Completed Phase 1 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT01200940 is a Phase 1 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 118 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01200940, a Phase 1 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 118 participants
- Enrollment target
Study 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
Primary Outcome
After a 10-hour fast, subjects will drink a 75-gram oral glucose solution. Samples will be drawn at -10, 0, 10, 20, 30, 60, 90, and 120 minutes.
Interventions
- OTHER Control
- OTHER Aspartame
- OTHER Sucralose
- OTHER Acesulfame-Potassium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2010-11-04 |
| Est. Completion | 2017-03-30 |
| Phase | Phase 1 |
What the finished NCT01200940 record still lists
NCT01200940 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% higher).
The record links to 0 conditions, and to 4 interventions - of which Control is the first listed.
NCT01200940 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01200940 about?
NCT01200940 is a clinical study titled "Metabolic Effects of Non-Nutritive Sweeteners". 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 ...
What is the current status of trial NCT01200940?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 118 participants. The study started on 2010-11-04. Estimated completion is 2017-03-30.
What interventions are being tested in trial NCT01200940?
The interventions under investigation include: Control (OTHER), Aspartame (OTHER), Sucralose (OTHER), Acesulfame-Potassium (OTHER).
Who is sponsoring clinical trial NCT01200940?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01200940's enrollment target sits among peer trials
118 499th of 2000 higher than 1,502 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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