Beverage Replacement for Childhood Obesity

(SPARKLE Trial)

Recruiting at 2 trial locations

Overseen By Nana Gletsu Miller, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Nana Gletsu Miller

Disqualifiers: Pregnancy, Diabetes, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

63 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether swapping sugary sodas for healthier drinks can improve the health of Black/African American and Latine adolescents who enjoy sweet drinks and have obesity. The researchers aim to determine if these swaps can alter participants' preferences for sugary drinks and enhance their overall diet and heart health. Participants will replace sugary sodas with plain water, unsweetened sparkling water, or drinks with gradually decreasing sugar levels. This trial suits teens who prefer very sweet drinks and are willing to switch to study beverages without following a special diet. As an unphased trial, it offers participants a unique opportunity to contribute to important research that could lead to healthier lifestyle changes.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that unsweetened sparkling water changed how teenagers perceive sweetness, with no major side effects reported, indicating it is generally well-tolerated. Research has shown that gradually reducing sugar in drinks can lower the risk of obesity in children. Studies have not identified specific safety concerns regarding these drinks.

Both approaches aim to reduce sugar intake, a common and safe method to improve health. This trial is labeled as "Not Applicable" for phase, suggesting no major safety issues are expected, as is often the case with dietary changes rather than new drugs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these beverage replacement strategies for childhood obesity because they offer practical, non-pharmaceutical options that could easily fit into daily life. Unlike traditional methods that might focus on diet pills or restrictive dieting, these interventions use simple beverage swaps to gradually reduce sugar intake. The Plain Water Replacement serves as a straightforward control, while the Unsweetened Sparkling Water Replacement adds a fun twist with carbonation and flavor without added sugars. The Progressively Reduced Sugar Beverage Replacement is particularly innovative, as it gently guides participants to adjust to less sugar over time, potentially leading to more sustainable lifestyle changes. These approaches could help families tackle obesity by making small, manageable changes to drinking habits.

What evidence suggests that this trial's treatments could be effective for childhood obesity?

This trial will compare different beverage replacement strategies to reduce sugar intake in children. Participants in one arm will replace sugary sodas with unsweetened sparkling water. Research has shown that swapping sugary sodas for unsweetened sparkling water can lower added sugar consumption and might reduce children's preference for sweet drinks over time, leading to healthier eating habits and better heart health.

Another arm will involve progressively reducing sugar in beverages. For drinks with gradually less sugar, evidence suggests that cutting back on sugary drinks can significantly reduce obesity and related diseases like type 2 diabetes. Studies have found that children who drink fewer sugary drinks tend to gain less weight. Overall, both strategies appear promising for improving health by reducing sugar intake. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for Black/African American and Latine adolescents with obesity who enjoy sweet beverages. They should be willing to replace sugary sodas with alternative drinks provided by the study for 4 weeks, participate in taste tests, and provide dietary information, body measurements, and blood samples over an 8-week period.

Inclusion Criteria

I am a teenager who prefers very sweet drinks.

My BMI is in the top 5% for my age, indicating obesity.

I am willing to drink the study beverages and am not on a diet.

Exclusion Criteria

I am a pregnant teenager.

I am a teenager with type 1 or type 2 diabetes.

Participant is allergic or intolerant to the items being tested.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants replace sugary sodas with study drinks for 4 weeks, including unsweetened sparkling water, plain water, or progressively reduced sugar beverages.

4 weeks

Visits at baseline, week 2, and week 4

Follow-up

Participants are monitored for changes in liking for sugar concentrations, diet quality, and cardiometabolic health markers.

4 weeks

Visits at week 4 and week 8

What Are the Treatments Tested in This Trial?

Interventions

• Plain Water Replacement
• Progressively Reduced Sugar Beverage Replacement
• Unsweetened Sparkling Water Replacement

Trial Overview The study is testing if replacing sugary sodas with unsweetened sparkling water, plain water or a beverage that has progressively less sugar can decrease sugar intake and improve health outcomes. It will measure changes in preference for sweetness as well as diet quality and cardiometabolic health.

How Is the Trial Designed?

Group I: Unsweetened Sparkling Water (USW) Experimental Treatment 1 Intervention

Participants in this group will replace all sugar-sweetened sodas with flavored, unsweetened sparkling waters for 4 weeks.

Group II: Progressively Reduced Sugar (PRS) Experimental Treatment 1 Intervention

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.

Group III: Plain Water (PW) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Nana Gletsu Miller

Lead Sponsor

Purdue University

Collaborator

Trials

239

Recruited

72,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5325726/

There is sufficient scientific evidence that decreasing sugar ... Compelling evidence indicates that reducing SSBs will have significant impact on the prevalence of obesity and its related diseases, especially T2D.

2. withpower.com withpower.com/trial/phase-obesity-6-2025-b75ff

Beverage Replacement for Childhood Obesity The goal of this clinical trial is to test whether replacing sugary sodas with unsweetened, flavored sparkling waters can reduce added sugar ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523052760

Sugar-sweetened beverages and weight gain in children ... RCTs in children showed reductions in BMI gain when SSBs were reduced [random and fixed effects: −0.17 (95% CI: −0.39, 0.05) and −0.12 (95% CI: −0.22, −0.2)], ...

4. mdpi.com mdpi.com/2306-5710/11/5/137

Childhood Obesity and Its Physiological Association with ... Effective mitigation of childhood obesity requires comprehensive approaches that emphasize reducing all sweetened beverage consumption, promoting water and ...

5. who.int who.int/tools/elena/interventions/ssbs-childhood-obesity

Reducing consumption of sugar-sweetened beverages to ... Therefore, reducing consumption of sugar-sweetened beverages would also reduce the risk of childhood overweight and obesity.

6. healthyeatingresearch.org healthyeatingresearch.org/wp-content/uploads/2025/01/Technical-Report-FINAL.pdf

Healthy beverage consumption in school-age children and ... Modelling the Effects of Beverage. Substitution during Adolescence on Later Obesity Outcomes in Early. Adulthood: Results from the Raine Study.

7. episeminars.web.unc.edu episeminars.web.unc.edu/wp-content/uploads/sites/7549/2014/09/ma-lancet-2016.pdf

Gradual reduction of sugar in soft drinks without ... In this study, we propose a strategy in which free sugars added to sugar-sweetened beverages are reduced gradually by. 40% over 5 years without ...