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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое Unsweetened Sparkling Water Replacement
  Participants replace all sugar-sweetened sodas with flavored, unsweetened sparkling waters for 4 weeks.
• Поведенческое Progressively Reduced Sugar Beverage Replacement
  Participants replace sugary sodas with beverages containing gradually decreasing sugar concentrations (weekly), ending with unsweetened sparkling water.
• Поведенческое Plain Water Replacement
  Participants replace all sugar-sweetened sodas with plain, still water for 4 weeks. This serves as a comparator to evaluate sensory and metabolic changes.

Первичные конечные точки

• Liking ratings changes for sugar concentrations over time [Срок оценки: Baseline, Week 2, Week 4, Week 8]

Вторичные конечные точки (10)

• Diet quality changes over time [Срок оценки: Baseline, Week 4, Week 8]
• Serum triglyceride changes over time [Срок оценки: Baseline, Week 4, Week 8]
• Change in fasting glucose over time [Срок оценки: Baseline, Week 4, Week 8]
• Change in insulin resistance over time [Срок оценки: Baseline, Week 4, Week 8]
• Change in BMI (body mass index) z-score [Срок оценки: Baseline, Week 4, Week 8]
• Beverage Consumption Compliance [Срок оценки: Baseline, Week 4, Week 8]
• Change in Systolic Blood Pressure [Срок оценки: Baseline, Week 4, Week 8]
• Change in Diastolic Blood Pressure [Срок оценки: Baseline, Week 4, Week 8]
• Change in Waist Circumference [Срок оценки: Baseline, Week 4, Week 8]
• Number of Participants experiencing tooth sensitivity or gastrointestinal symptoms [Срок оценки: Week 4]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 3 центра

• Indiana University School of Public Health - Bloomington — Bloomington
• Indiana University Hospital — Indianapolis
• Purdue University — West Lafayette

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07223151 · IRB#25860 · IRB#25860

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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