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Obesity, AdolescentSPARKLENCT07223151

A Sensory Strategy to Cut Sugary Beverages in African/American and Latine Adolescents

A study testing Unsweetened Sparkling Water Replacement, Progressively Reduced Sugar Beverage Replacement and Plain Water Replacement in people with Obesity, Adolescent and Dietary Sugars, run by Nana Gletsu Miller at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 18 yearsHealthy volunteers can take part
What is being tested?
Unsweetened Sparkling Water Replacement, Progressively Reduced Sugar Beverage Replacement and Plain Water Replacement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
3 sitesUnited States
Study dates
25 Jul 2025to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Adolescents ages 12 to 18 who display a "sweet-liker" pattern, characterized by a preference for higher concentrations of sugar in beverages, specifically identifying 0.3M (10.3% sucrose) or above as their most liked sample.
  • Adolescents consumes sugar-sweetened soda greater than or equal to 2 times per week. Adolescents must also indicate a willingness to drink study beverages; not currently dieting/changing diet.

Who cannot join

  • Adolescent participant is pregnant, since pregnancy affects taste perception
  • Participant is allergic or intolerant to the items we are testing.
  • Adolescent with type 1 or type 2 diabetes (self-declared or detected at screening visit through fasting glucose)
  • Use of GLP-1 receptor agonists intended for weight loss.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nana Gletsu Miller, PhD contact

+1 (812) 855-9110

ngletsum@iu.edu

United States3 sites, 3 recruiting
  • Indiana University School of Public Health - Bloomington

    Bloomington, Indiana, 47405

    Nana Gletsu Miller, PhD, 812-855-9110, ngletsum@iu.edu

    Not yet recruiting
  • Indiana University Hospital

    Indianapolis, Indiana, 46202

    Nana Gletsu Miller, PhD, 812-855-7643, ngletsum@iu.edu

    Recruiting
  • Purdue University

    West Lafayette, Indiana, 47907

    Cordelia Running, PhD, 765-494-2282, crunning@purdue.edu

    Recruiting

Other trials in United States

About this study

Official title: Trading Sugar for Sparkles in Adolescents, A Sensory Approach for Reducing Added Sugar From Sweetened Beverages

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?
Read more

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
Read the detailed description

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.

Being tested
Unsweetened Sparkling Water Replacement, Progressively Reduced Sugar Beverage Replacement, Plain Water Replacement
Keywords
Obesity, Adolescent, Sugar-Sweetened Beverages, Taste Perception, Insulin Resistance, Sweet Taste Preference, Latine Youth, African American Youth, Dietary Intervention, Beverage Replacement, Sugar Reduction, Sensory Evaluation, Randomized Controlled Trial
Medical subject headings
Pediatric Obesity, Insulin Resistance, Feeding Behavior, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Unsweetened Sparkling Water ReplacementBehavioural

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

  • Progressively Reduced Sugar Beverage ReplacementBehavioural

    Participants replace sugary sodas with beverages containing gradually decreasing sugar concentrations (weekly), ending with unsweetened sparkling water.

  • Plain Water ReplacementBehavioural

    Participants replace all sugar-sweetened sodas with plain, still water for 4 weeks. This serves as a comparator to evaluate sensory and metabolic changes.

Study groups in NCT07223151
Study groupRoleWhat they receive
Unsweetened Sparkling Water (USW)ExperimentalParticipants in this group will replace all sugar-sweetened sodas with flavored, unsweetened sparkling waters for 4 weeks.
Receives: Behavioral: Unsweetened Sparkling Water Replacement
Progressively Reduced Sugar (PRS)ExperimentalParticipants 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.
Receives: Behavioral: Progressively Reduced Sugar Beverage Replacement
Plain Water (PW)Active comparatorParticipants 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.
Receives: Behavioral: Plain Water Replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 2, Week 4, Week 8

Secondary outcomes (10)
  1. 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.

    Measured: Baseline, Week 4, Week 8

  2. 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.

    Measured: Baseline, Week 4, Week 8

  3. Change in fasting glucose over time

    We will also evaluate fasting glucose by serum analysis.

    Measured: Baseline, Week 4, Week 8

  4. 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.

    Measured: Baseline, Week 4, Week 8

  5. Change in BMI (body mass index) z-score

    We will also evaluate BMI z-score for changes over time

    Measured: Baseline, Week 4, Week 8

  6. Beverage Consumption Compliance

    Participants report their beverage consumption and compliance will be assessed.

    Measured: Baseline, Week 4, Week 8

  7. Change in Systolic Blood Pressure

    Systolic Blood Pressure change over time will be evaluated.

    Measured: Baseline, Week 4, Week 8

  8. Change in Diastolic Blood Pressure

    Diastolic Blood Pressure change over time will be evaluated.

    Measured: Baseline, Week 4, Week 8

  9. Change in Waist Circumference

    Waist circumference will be evaluated over time.

    Measured: Baseline, Week 4, Week 8

  10. Number of Participants experiencing tooth sensitivity or gastrointestinal symptoms

    Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2025
  2. Study start25 Jul 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are randomly assigned to one of three parallel intervention arms for 4 weeks: (1) replacement of sugary sodas with unsweetened, flavored sparkling water (USW), (2) replacement with sodas containing progressively reduced sugar levels (PRS), or (3) replacement with plain water (PW). All participants are followed for an additional 4-week period to assess maintenance of changes.
Masking
None (open label)
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07223151
Sponsor's protocol ID
IRB#25860
Other IDs
IRB#25860
Acronym
SPARKLE
Status last verified
Aug 2026
First submitted
30 Jul 2025
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999 Sep;22(9):1462-70. doi: 10.2337/diacare.22.9.1462.

    PubMed 10480510
  • Wang J, Light K, Henderson M, O'Loughlin J, Mathieu ME, Paradis G, Gray-Donald K. Consumption of added sugars from liquid but not solid sources predicts impaired glucose homeostasis and insulin resistance among youth at risk of obesity. J Nutr. 2014 Jan;144(1):81-6. doi: 10.3945/jn.113.182519. Epub 2013 Nov 6.

    PubMed 24198307
  • Boushey CJ, Kerr DA, Wright J, Lutes KD, Ebert DS, Delp EJ. Use of technology in children's dietary assessment. Eur J Clin Nutr. 2009 Feb;63 Suppl 1(Suppl 1):S50-7. doi: 10.1038/ejcn.2008.65.

    PubMed 19190645
  • Bailey RL, Fulgoni VL, Cowan AE, Gaine PC. Sources of Added Sugars in Young Children, Adolescents, and Adults with Low and High Intakes of Added Sugars. Nutrients. 2018 Jan 17;10(1):102. doi: 10.3390/nu10010102.

    PubMed 29342109
  • Reedy J, Krebs-Smith SM. Dietary sources of energy, solid fats, and added sugars among children and adolescents in the United States. J Am Diet Assoc. 2010 Oct;110(10):1477-84. doi: 10.1016/j.jada.2010.07.010.

    PubMed 20869486
  • Banfield EC, Liu Y, Davis JS, Chang S, Frazier-Wood AC. Poor Adherence to US Dietary Guidelines for Children and Adolescents in the National Health and Nutrition Examination Survey Population. J Acad Nutr Diet. 2016 Jan;116(1):21-27. doi: 10.1016/j.jand.2015.08.010. Epub 2015 Sep 26.

    PubMed 26391469
  • Andes LJ, Cheng YJ, Rolka DB, Gregg EW, Imperatore G. Prevalence of Prediabetes Among Adolescents and Young Adults in the United States, 2005-2016. JAMA Pediatr. 2020 Feb 1;174(2):e194498. doi: 10.1001/jamapediatrics.2019.4498. Epub 2020 Feb 3.

    PubMed 31790544
  • Valicente V, Gletsu-Miller N, Running CA. Secondary Analysis of Sweetness Liking from Pilot Study Replacing Sugar Sweetened Soda with Flavored, Unsweetened Sparkling Water. J Am Nutr Assoc. 2025 Jan;44(1):1-13. doi: 10.1080/27697061.2024.2369819. Epub 2024 Jul 22.

    PubMed 39037472

Questions about this trial

What is this clinical trial studying?

A study testing Unsweetened Sparkling Water Replacement, Progressively Reduced Sugar Beverage Replacement and Plain Water Replacement in people with Obesity, Adolescent and Dietary Sugars, run by Nana Gletsu Miller at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nana Gletsu Miller, PhD (+1 (812) 855-9110, ngletsum@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Liking ratings changes for sugar concentrations over time (time frame: Baseline, Week 2, Week 4, Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07223151, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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