Unsweetened Sparkling Water Replacement
BehavioralParticipants replace all sugar-sweetened sodas with flavored, unsweetened sparkling waters for 4 weeks.
NCT Number: NCT07223151
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:
* Does replacing sugary sodas with water change liking for sugary drinks, and water? * Do shifts in liking for sweetness lead to improved diet quality and cardiometabolic health?
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:
* Replace sugary sodas with study drinks for 4 weeks * Complete taste tests to measure their liking for and sensory experience of sweetness over 8-weeks * Provide dietary recalls, body measurements, and blood samples over 8-weeks
Interested in participating?
Request Info12 year–18 year
All sexes
Interventional
Not applicable
Indiana University School of Public Health - Bloomington, Bloomington, Indiana, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For the secondary objective. Exclusion Criteria:
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.
Time frame: Baseline, Week 2, Week 4, Week 8
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 4, Week 8
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
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
We will also evaluate fasting glucose by serum analysis.
Time frame: Baseline, Week 4, Week 8
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
We will also evaluate BMI z-score for changes over time
Time frame: Baseline, Week 4, Week 8
Participants report their beverage consumption and compliance will be assessed.
Time frame: Baseline, Week 4, Week 8
Systolic Blood Pressure change over time will be evaluated.
Time frame: Baseline, Week 4, Week 8
Diastolic Blood Pressure change over time will be evaluated.
Time frame: Baseline, Week 4, Week 8
Waist circumference will be evaluated over time.
Time frame: Week 4
Contact information is provided by the study sponsor or research team.
Nana Gletsu Miller
Other
Trading Sugar for Sparkles in Adolescents, A Sensory Approach for Reducing Added Sugar From Sweetened Beverages
Acronym: SPARKLE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05982847
Behavior, Body Weight
Mthatha, Eastern Cape, South Africa
View Trial DetailsNCT06515288
Body Weight, Nutrition Disorders
Jakarta, The Special Capital Region of Jakarta, Indonesia
View Trial DetailsNCT04213014
Behavior, Body Weight
Ann Arbor, Michigan, United States
View Trial DetailsNCT04252677
Behavior, Body Weight
New York, United States
View Trial Details