Trading Sugar for Sparkles in Adolescents, A Sensory Approach for Reducing Added Sugar From Sweetened Beverages
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 63
- 试验地点
- 3
- 主要终点
- Liking ratings changes for sugar concentrations over time
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Not applicable. This is an open-label study; no parties are masked.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Unsweetened Sparkling Water (USW)
Participants in this group will replace all sugar-sweetened sodas with flavored, unsweetened sparkling waters for 4 weeks.
干预措施: Unsweetened Sparkling Water Replacement (Behavioral)
Progressively Reduced Sugar (PRS)
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.
干预措施: Progressively Reduced Sugar Beverage Replacement (Behavioral)
Plain Water (PW)
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.
干预措施: Plain Water Replacement (Behavioral)
结局指标
主要结局
Liking ratings changes for sugar concentrations over time
时间窗: 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.
次要结局
- Change in fasting glucose over time(Baseline, Week 4, Week 8)
- Change in insulin resistance over time(Baseline, Week 4, Week 8)
- Diet quality changes over time(Baseline, Week 4, Week 8)
- Serum triglyceride changes over time(Baseline, Week 4, Week 8)
- Change in BMI (body mass index) z-score(Baseline, Week 4, Week 8)
- Beverage Consumption Compliance(Baseline, Week 4, Week 8)
- Change in Systolic Blood Pressure(Baseline, Week 4, Week 8)
- Change in Diastolic Blood Pressure(Baseline, Week 4, Week 8)
- Change in Waist Circumference(Baseline, Week 4, Week 8)
- Number of Participants experiencing tooth sensitivity or gastrointestinal symptoms(Week 4)
研究者
Nana Gletsu Miller
Associate Professor, Applied Health Science, Indiana University Bloomington
Indiana University