A Sensory Strategy to Cut Sugary Beverages in African/American and Latine Adolescents
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorNana Gletsu Miller
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Unsweetened Sparkling Water Replacement
BehavioralParticipants replace all sugar-sweetened sodas with flavored, unsweetened sparkling waters for 4 weeks.
Progressively Reduced Sugar Beverage Replacement
BehavioralParticipants replace sugary sodas with beverages containing gradually decreasing sugar concentrations (weekly), ending with unsweetened sparkling water.
Plain Water Replacement
BehavioralParticipants replace all sugar-sweetened sodas with plain, still water for 4 weeks. This serves as a comparator to evaluate sensory and metabolic changes.
Treatment groups
63 Participants
are divided into 3 treatment groupsGroup A: Unsweetened Sparkling Water (USW)Experimental treatment 1 intervention
Group B: Progressively Reduced Sugar (PRS)Experimental treatment 1 intervention
Group C: Plain Water (PW)Active comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, Week 2, Week 4, Week 8Secondary outcomes
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.
Time frame
Baseline, Week 4, Week 82
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.
Time frame
Baseline, Week 4, Week 83
Change in fasting glucose over time
We will also evaluate fasting glucose by serum analysis.
Time frame
Baseline, Week 4, Week 84
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.
Time frame
Baseline, Week 4, Week 8Sponsors and contacts
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Source ClinicalTrials.gov