An interventional study of Unsweetened Sparkling Water Replacement and Progressively Reduced Sugar Beverage Replacement in Obesity, Adolescent, Dietary Sugars and Taste Perception, sponsored by Nana Gletsu Miller. Recruiting at 3 sites in United States. Open to participants aged 12 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Nana Gletsu Miller · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to test whether replacing sugary sodas with unsweetened, flavored sparkling waters can reduce added sugar intake and improve health in Black/African American and Latine adolescents with obesity who prefer sweet-tasting beverages. The main questions it aims to answer are:
Researchers will compare replacing sugary sodas with one of three alternative beverages: unsweetened sparkling water, plain water, and beverages with gradually reduced sugar to determine which strategy is most effective.
Participants will:
This randomized controlled trial aims to evaluate the effects of replacing sugar-sweetened sodas with unsweetened, flavored sparkling waters, progressively sugar-reduced sodas, or plain water in adolescents who are classified as "sweet-likers"-individuals who prefer higher concentrations of sugar in beverages. The study focuses on a high-risk group: adolescents ages 12-18 who self-identify as Black/African American or Latine and have obesity (BMI >95th percentile).
63 adolescents who are classified as sweet-likers and meet additional inclusion criteria will be enrolled in a randomized 3-arm intervention for 4 weeks, with an additional 4-week follow-up period. Participants will be randomized into one of the following groups:
USW (Unsweetened Sparkling Water): Replaces sodas with flavored, unsweetened carbonated water.
PRS (Progressively Reduced Sugar): Replaces sodas with carbonated beverages with decreasing sugar concentrations, ending with unsweetened carbonated water.
PW (Plain Water - Control): Replaces sodas with still, plain water.
Participants will replace all typical sugary sodas with study beverages during the 4-week intervention. Study assessments include sensory testing for liking, sweetness intensity, and "just about right" level of sweetness in sparkling and plain water at baseline, week 2, week 4, and week 8. Additionally, dietary intake (via 24-hour dietary recalls), anthropometrics (height, weight, waist circumference), blood pressure, and blood biomarkers (fasting glucose, insulin, triglycerides) will be measured at baseline, week 4, and week 8.
The primary hypothesis is that exposure to unsweetened beverages (especially in the USW and PRS groups) will reduce participants' liking for higher concentrations of sugar in beverages and increasing liking for lower concentrations of sugar in beverages. It is also hypothesized that these changes may correspond with improvements in cardiometabolic markers, particularly serum triglycerides. Insulin resistance (HOMA-IR), blood pressure, and body weight will also be measured but are less likely to shift in the relatively short time period (8 weeks).
This trial addresses the persistent challenge of high SSB consumption in racial and ethnic minority adolescents-a group that faces disproportionate risk of obesity, prediabetes, and cardiometabolic disease. By integrating sensory science with behavior change, this intervention seeks to develop more effective strategies to support reduced sugar intake in adolescents who have strong preferences for sweetness.
Exclusion Criteria:
Participants in this group will replace all sugar-sweetened sodas with flavored, unsweetened sparkling waters for 4 weeks.
Behavioral: Unsweetened Sparkling Water Replacement
Participants in this group will replace sugar-sweetened sodas with carbonated beverages that contain decreasing levels of sugar each week over a 4-week period, ending with a fully unsweetened sparkling water.
Behavioral: Progressively Reduced Sugar Beverage Replacement
Participants in this group will replace all sugar-sweetened sodas with plain, still water for 4 weeks. This arm serves as a control to compare outcomes against both the unsweetened sparkling water and gradually reduced sugar beverage interventions.
Behavioral: Plain Water Replacement
Participants replace all sugar-sweetened sodas with flavored, unsweetened sparkling waters for 4 weeks.
Participants replace sugary sodas with beverages containing gradually decreasing sugar concentrations (weekly), ending with unsweetened sparkling water.
Participants replace all sugar-sweetened sodas with plain, still water for 4 weeks. This serves as a comparator to evaluate sensory and metabolic changes.
Liking ratings changes for sugar concentrations over time
Our primary outcome is the interaction of time with liking for different sugar concentrations. We expect to observe a significant Time\*Sugar Concentration interaction effect for these liking ratings. We expect the interaction term to show that higher concentrations of sugar had lower liking ratings by weeks 4 and 8 (compared to baseline), but that lower concentrations of sugar had higher liking ratings by weeks 4 and 8. Liking ratings are collected on a scale from -110 to 110, with internal markings at -100 Worst ever, -50 Dislike, 0 Neutral, 50 Like, 100 Best ever.
Time frame: Baseline, Week 2, Week 4, Week 8
Diet quality changes over time
We will use the ASA24 method to gather data on food intake. We will apply the Healthy Eating Index method to calculate diet quality. We expect to see improvements in diet quality at weeks 4 and 8 compared to baseline.
Time frame: Baseline, Week 4, Week 8
Serum triglyceride changes over time
A secondary outcome is the main effect of time on serum triglycerides. We expect to observe significant decreases in serum triglycerides at weeks 4 and 8 compared to baseline.
Time frame: Baseline, Week 4, Week 8
Change in fasting glucose over time
We will also evaluate fasting glucose by serum analysis.
Time frame: Baseline, Week 4, Week 8
Change in insulin resistance over time
We will also evaluate insulin resistance (HOMA-IR), which is a measure of fasting glucose multiplied by fasting insulin.
Time frame: Baseline, Week 4, Week 8
Change in BMI (body mass index) z-score
We will also evaluate BMI z-score for changes over time
Time frame: Baseline, Week 4, Week 8
Beverage Consumption Compliance
Participants report their beverage consumption and compliance will be assessed.
Time frame: Baseline, Week 4, Week 8
Change in Systolic Blood Pressure
Systolic Blood Pressure change over time will be evaluated.
Time frame: Baseline, Week 4, Week 8
Change in Diastolic Blood Pressure
Diastolic Blood Pressure change over time will be evaluated.
Time frame: Baseline, Week 4, Week 8
Change in Waist Circumference
Waist circumference will be evaluated over time.
Time frame: Baseline, Week 4, Week 8
Number of Participants experiencing tooth sensitivity or gastrointestinal symptoms
Time frame: Week 4
Plan to share: No — Individual participant data will not be shared due to the sensitive nature of the data collected from a minor population (adolescents), limited consent for data sharing. Future data sharing may be reconsidered following additional ethical review and participant re-consent where appropriate.
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