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

NCT07223151 | Recruiting

• 1 other identifier: IRB#25860
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 3

Brief 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. 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

Conditions

Obesity, Adolescent; Dietary Sugars; Taste Perception; Insulin Resistance; Feeding Behavior

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

Outcome Measures

Primary Outcomes (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.

  Baseline, Week 2, Week 4, Week 8

Secondary Outcomes (10)

• Diet quality changes over time

  Baseline, Week 4, Week 8

• Serum triglyceride changes over time

  Baseline, Week 4, Week 8

• Change in fasting glucose over time

  Baseline, Week 4, Week 8

• Change in insulin resistance over time

  Baseline, Week 4, Week 8

• Change in BMI (body mass index) z-score

  Baseline, Week 4, Week 8

Study Arms (3)

Unsweetened Sparkling Water (USW)

EXPERIMENTAL

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

Behavioral: Unsweetened Sparkling Water Replacement

Progressively Reduced Sugar (PRS)

EXPERIMENTAL

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

Plain Water (PW)

ACTIVE COMPARATOR

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

Interventions

Unsweetened Sparkling Water Replacement BEHAVIORAL

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

Unsweetened Sparkling Water (USW)

Progressively Reduced Sugar Beverage Replacement BEHAVIORAL

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

Progressively Reduced Sugar (PRS)

Plain Water Replacement BEHAVIORAL

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

Plain Water (PW)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Have obesity (body mass index \[BMI\] \> 95%). During screening, subjects' height and weight will be measured to calculate BMI, and BMI will be balanced across study arms using stratified randomization.
• Adolescents must also indicate a willingness to drink study beverages; not currently dieting/changing diet.

You may not qualify if:

• 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)
• Currently consume unsweetened, sparkling water two or more times per week.
• Adolescent participant is pregnant, since pregnancy affects taste perception
• Participant is allergic or intolerant to the items we are testing.
• Allergic or intolerant to the items that we are testing.

Sponsors & Collaborators

• Nana Gletsu Miller: lead
• Purdue University: collaborator

Study Sites (3)

Indiana University School of Public Health - Bloomington

Bloomington, Indiana, 47405, United States

NOT YET RECRUITING

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

Purdue University

West Lafayette, Indiana, 47907, United States

RECRUITING

Related Publications (8)

• 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.

  PMID: 10480510 BACKGROUND

• 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.

  PMID: 24198307 BACKGROUND

• 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.

  PMID: 19190645 BACKGROUND

• 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.

  PMID: 29342109 BACKGROUND

• 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.

  PMID: 20869486 BACKGROUND

• 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.

  PMID: 26391469 BACKGROUND

• 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.

  PMID: 31790544 BACKGROUND

• 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.

  PMID: 39037472 BACKGROUND

Related Links

• All IN for Health Research Studies - Study Listing for "Trading Sugar for Sparkles"

MeSH Terms

Conditions

Pediatric Obesity; Insulin Resistance; Feeding Behavior; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Behavior, Animal; Behavior

Central Study Contacts

Nana Gletsu Miller, PhD

CONTACT

+1 (812) 855-9110; ngletsum@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable. This is an open-label study; no parties are masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Applied Health Science, Indiana University Bloomington

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: October 31, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)