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NCT05966870 · ClinicalTrials.gov registry record · NA
Unsweetened Sparkling Water and Changes in Sweetness Perception in Adolescents
A NA study, sponsored by Indiana University.
- Terminated
- Registry status
- NA
- Development phase
- 22
- Enrollment target
NCT05966870 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 22 participants.
The verdict
NCT05966870, a NA study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- NA
- Development phase
- 22 participants
- Enrollment target
Study Summary
The study design is a prospective observational study in adolescents who are at risk for developing Type 2 Diabetes (T2D), to evaluate the effectiveness of sparkling water to reduce dietary intake of added sugars and thereby improve glycemia. Study data on consumption and the flavor profile of sparkling water will serve as a measure of acceptability. The study intervention will be to provide carbonated flavored sparkling water for 12 weeks to adolescents (and their families) who have a usual intake of 2 or more servings of sugar sweetened beverages (SSB) per day and are at a high risk for developing type 2 diabetes. Study measures will be obtained before and after the exposure to carbonated flavored sparkling water and each participant will serve as his/her own control. To encourage the participants to substitute the carbonated flavored sparkling water, study personnel will send them weekly iMessages through the Technology Assisted Dietary Assessment (TADA) app. In addition, investigators will monitor the participants' diet, using the TADA app, every two weeks, for 4 days. Study measurements will be obtained at baseline, before the intervention, during and at the end of the 12 week intervention. Objective: Determine the effect of reducing added sugars intake by substituting carbonated sparkling water on T2D risk in adolescents. Hypothesis: Adolescents who decrease consumption of SSB by substituting sparkling water will experience decreased blood glucose concentrations and increased insulin sensitivity during an oral glucose tolerance test and decreased glucose excursions during continued glucose monitoring, compared to those who do not decrease consumption of SSB.
Interventions
- OTHER Unsweetened flavored sparkling water
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2020-03-09 |
| Est. Completion | 2021-06-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05966870
The ClinicalTrials.gov registry entry for NCT05966870 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Unsweetened flavored sparkling water is the first listed.
NCT05966870 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05966870 about?
NCT05966870 is a clinical study titled "Unsweetened Sparkling Water and Changes in Sweetness Perception in Adolescents". The study design is a prospective observational study in adolescents who are at risk for developing Type 2 Diabetes (T2D), to evaluate the effectiveness of sparkling water to reduce dietary intake of added sugars and thereby improve glycemia. Study data on consumption and the flavor profile of spark...
What is the current status of trial NCT05966870?
This trial is currently terminated. It is a NA study. The enrollment target is 22 participants. The study started on 2020-03-09. Estimated completion is 2021-06-20.
What interventions are being tested in trial NCT05966870?
The interventions under investigation include: Unsweetened flavored sparkling water (OTHER).
Who is sponsoring clinical trial NCT05966870?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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