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NCT03944616 · ClinicalTrials.gov registry record · NA
Study Of Drinks With Artificial Sweeteners in People With Type 2 Diabetes
A NA study, sponsored by University of California, Irvine.
- Completed
- Registry status
- NA
- Development phase
- 181
- Enrollment target
NCT03944616 is a NA study that has completed, run by University of California, Irvine. The registered enrollment target is 181 participants.
The verdict
NCT03944616, a NA study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- NA
- Development phase
- 181 participants
- Enrollment target
Study Summary
Diet beverages sweetened with artificial sweeteners occupy a unique category in the food environment as they are a source of intensely sweet taste with no calories. Diet beverages are the single largest contributor to artificial sweetener intake in the U.S. diet, and people with diabetes are the highest consumers of diet beverages, tending to consume them as a replacement for dietary sources of sugar, especially in place of sugar-sweetened beverages. This behavior has been endorsed by dietetic and scientific organizations, and diet beverages are marketed as being synonymous with better health, suitable for weight loss, and thus advantageous for diabetes control. The underlying public health concern is that there are few data to support or refute the benefit or harm of habitual diet beverage consumption by people with diabetes; therefore randomized trials with relevant outcomes must be conducted because they would address many limitations of previous research and have major implications for dietary recommendations on diet beverage intake and primary and secondary prevention of chronic disease. To begin addressing this important scientific gap the investigators are testing the effect of diet beverage intake on diabetes control parameters in free-living adults with type 2 diabetes in a randomized, two arm parallel trial with a run-in period of 2-weeks and an active intervention period of 24-weeks. This study will recruit 200 patients with type 2 diabetes who are usual consumers of commercial diet beverages and randomize them to receive and consume either: 1) A commercial diet beverage of choice (3 servings or 24 oz. daily); or 2) Unflavored bottled water of choice (sparkling or plain) (3 servings or 24 oz. daily). The primary outcome will be a central measure of clinical diabetes control in glycated hemoglobin (HbA1c). The study will also measure the nature and magnitude of glycemic excursions via continuous glucose monitors, as well as clinical markers of cardiometabo
Interventions
- BEHAVIORAL Diet Beverage
- BEHAVIORAL Water
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2019-06-06 |
| Est. Completion | 2024-03-21 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03944616
The ClinicalTrials.gov registry entry for NCT03944616 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 181 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Diet Beverage is the first listed.
NCT03944616 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03944616 about?
NCT03944616 is a clinical study titled "Study Of Drinks With Artificial Sweeteners in People With Type 2 Diabetes". Diet beverages sweetened with artificial sweeteners occupy a unique category in the food environment as they are a source of intensely sweet taste with no calories. Diet beverages are the single largest contributor to artificial sweetener intake in the U.S. diet, and people with diabetes are the hig...
What is the current status of trial NCT03944616?
This trial is currently completed. It is a NA study. The enrollment target is 181 participants. The study started on 2019-06-06. Estimated completion is 2024-03-21.
What interventions are being tested in trial NCT03944616?
The interventions under investigation include: Diet Beverage (BEHAVIORAL), Water (BEHAVIORAL).
Who is sponsoring clinical trial NCT03944616?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
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