Stopped: Because this study was initiated during the COVID pandemic, several outcome measures (including those requiring in-person assessments) were abandoned.
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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Change in Dietary Consumption of SSB and Sparkling Water
Timeframe: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in 2 Hour Glucose Concentrations
Timeframe: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Fasting Glucose
Timeframe: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Hemoglobin A1c (HbA1c) Concentration
Timeframe: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Whole-body Insulin Sensitivity Index (WBISI)
Timeframe: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Insulinogenic Index (IGI)
Timeframe: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Oral Disposition Index (oDI)
Timeframe: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Glycemic Control
Timeframe: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)