NCT05966870

Unsweetened Sparkling Water and Changes in Sweetness Perception in Adolescents

Terminated NA Results posted Last updated 12 February 2025

What this trial tests

NA trial testing Unsweetened flavored sparkling water in Obesity, Adolescent in 22 participants. Terminated before completion.

Timeline

9 March 2020

Primary endpoint
20 June 2021

20 June 2021

Quick facts

Lead sponsor	Indiana University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	22
Start date	9 March 2020
Primary completion	20 June 2021
Estimated completion	20 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Unsweetened flavored sparkling water

Conditions studied

• Obesity, Adolescent — all drugs for Obesity, Adolescent →
• PreDiabetes — all drugs for PreDiabetes →

Sponsor

Indiana University

Who can join

Adults 10 to 21, any sex, with Obesity, Adolescent or PreDiabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 0% (Weight Per Volume) Secondary · Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)

Participants consumed a test beverage with sugar concentration 0% (weight per volume), and rated the beverage using a "Just About Right" (JAR) visual analog scale for sweetness perception. The JAR scale anchors at: -100, "Not sweet enough"; -50, "Slightly not sweet enough"; 0, "Just about right"; +50, "Slightly too sweet"; and +100 "Too sweet." In this scale, the greater the deviation from zero the more suboptimal the perception.

JAR pre intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	-90	-95 – -20

JAR post intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	-75	-90 – -25

Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 1.8% (Weight Per Volume) Secondary · Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)

Participants consumed a test beverage with sugar concentration 1.8% (weight per volume), and rated the beverage using a "Just About Right" (JAR) visual analog scale for sweetness perception. The JAR scale anchors at: -100, "Not sweet enough"; -50, "Slightly not sweet enough"; 0, "Just about right"; +50, "Slightly too sweet"; and +100 "Too sweet." In this scale, the greater the deviation from zero the more suboptimal the perception.

JAR pre intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	-50	-95 – -30

JAR post intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	-20	-95 – 0

Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 2.8% (Weight Per Volume) Secondary · Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)

Participants consumed a test beverage with sugar concentration 2.8% (weight per volume), and rated the beverage using a "Just About Right" (JAR) visual analog scale for sweetness perception. The JAR scale anchors at: -100, "Not sweet enough"; -50, "Slightly not sweet enough"; 0, "Just about right"; +50, "Slightly too sweet"; and +100 "Too sweet." In this scale, the greater the deviation from zero the more suboptimal the perception.

JAR pre intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	-5	-45 – 0

JAR post intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	0	-50 – 30

Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 4.4% (Weight Per Volume) Secondary · Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)

Participants consumed a test beverage with sugar concentration 4.4% (weight per volume), and rated the beverage using a "Just About Right" (JAR) visual analog scale for sweetness perception. The JAR scale anchors at: -100, "Not sweet enough"; -50, "Slightly not sweet enough"; 0, "Just about right"; +50, "Slightly too sweet"; and +100 "Too sweet." In this scale, the greater the deviation from zero the more suboptimal the perception.

JAR pre intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	-10	-50 – 50

JAR post intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	5	-45 – 60

Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 6.8% (Weight Per Volume) Secondary · Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)

Participants consumed a test beverage with sugar concentration 6.8% (weight per volume), and rated the beverage using a "Just About Right" (JAR) visual analog scale for sweetness perception. The JAR scale anchors at: -100, "Not sweet enough"; -50, "Slightly not sweet enough"; 0, "Just about right"; +50, "Slightly too sweet"; and +100 "Too sweet." In this scale, the greater the deviation from zero the more suboptimal the perception.

JAR pre intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	30	-5 – 100

JAR post intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	60	5 – 100

Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 10.7% (Weight Per Volume) Secondary · Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)

Participants consumed a test beverage with sugar concentration 10.7% (weight per volume), and rated the beverage using a "Just About Right" (JAR) visual analog scale for sweetness perception. The JAR scale anchors at: -100, "Not sweet enough"; -50, "Slightly not sweet enough"; 0, "Just about right"; +50, "Slightly too sweet"; and +100 "Too sweet." In this scale, the greater the deviation from zero the more suboptimal the perception.

JAR pre intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	60	-5 – 100

JAR post intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	80	65 – 95

Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 0% (Weight Per Volume) Secondary · Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)

Participants consumed a test beverage with sugar concentration 0% (weight per volume) and rated the beverage for liking using a hedonic visual analog scale. This scale anchors at: -100, "Worst ever"; -50, "Dislike"; 0, "Neutral"; +50, "Like"; +100, "Best ever".

Liking rating pre intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	-45	-95 – 10

Liking rating post intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	7	-55 – 55

Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 1.8% (Weight Per Volume) Secondary · Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)

Participants consumed a test beverage with sugar concentration 1.8% (weight per volume) and rated the beverage for liking using a hedonic visual analog scale. This scale anchors at: -100, "Worst ever"; -50, "Dislike"; 0, "Neutral"; +50, "Like"; +100, "Best ever".

Liking rating pre intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	0	-67 – 100

Liking rating post intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	45	-4 – 100

Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 2.8% (Weight Per Volume) Secondary · Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)

Participants consumed a test beverage with sugar concentration 2.8% (weight per volume) and rated the beverage for liking using a hedonic visual analog scale. This scale anchors at: -100, "Worst ever"; -50, "Dislike"; 0, "Neutral"; +50, "Like"; +100, "Best ever".

Liking rating pre intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	25	-45 – 80

Liking rating post intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	50	-55 – 70

Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 4.4% (Weight Per Volume) Secondary · Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)

Participants consumed a test beverage with sugar concentration 4.4% (weight per volume) and rated the beverage for liking using a hedonic visual analog scale. This scale anchors at: -100, "Worst ever"; -50, "Dislike"; 0, "Neutral"; +50, "Like"; +100, "Best ever".

Liking rating pre intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	20	-60 – 80

Liking rating post intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	30	-30 – 80

Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 6.8% (Weight Per Volume) Secondary · Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)

Participants consumed a test beverage with sugar concentration 6.8% (weight per volume) and rated the beverage for liking using a hedonic visual analog scale. This scale anchors at: -100, "Worst ever"; -50, "Dislike"; 0, "Neutral"; +50, "Like"; +100, "Best ever".

Liking rating pre intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	50	-75 – 100

Liking rating post intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	25	-30 – 100

Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 10.7% (Weight Per Volume) Secondary · Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)

Participants consumed a test beverage with sugar concentration 10.7% (weight per volume) and rated the beverage for liking using a hedonic visual analog scale. This scale anchors at: -100, "Worst ever"; -50, "Dislike"; 0, "Neutral"; +50, "Like"; +100, "Best ever".

Liking rating pre intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	30	-65 – 97

Liking rating post intervention

Group	Value	95% CI
Replacement of SSB With Unsweetened Sparkling Beverage	35	-70 – 70

Sponsor's own description

The study design is a prospective observational study in adolescents who are at risk for developing Type 2 Diabetes (T2D), to evaluate the effectiveness of sparkling water to reduce dietary intake of added sugars and thereby improve glycemia. Study data on consumption and the flavor profile of sparkling water will serve as a measure of acceptability. The study intervention will be to provide carbonated flavored sparkling water for 12 weeks to adolescents (and their families) who have a usual intake of 2 or more servings of sugar sweetened beverages (SSB) per day and are at a high risk for developing type 2 diabetes. Study measures will be obtained before and after the exposure to carbonated flavored sparkling water and each participant will serve as his/her own control. To encourage the participants to substitute the carbonated flavored sparkling water, study personnel will send them weekly iMessages through the Technology Assisted Dietary Assessment (TADA) app. In addition, investigators will monitor the participants' diet, using the TADA app, every two weeks, for 4 days. Study measurements will be obtained at baseline, before the intervention, during and at the end of the 12 week intervention.

Objective: Determine the effect of reducing added sugars intake by substituting carbonated sparkling water on T2D risk in adolescents.

Hypothesis: Adolescents who decrease consumption of SSB by substituting sparkling water will experience decreased blood glucose concentrations and increased insulin sensitivity during an oral glucose tolerance test and decreased glucose excursions during continued glucose monitoring, compared to those who do not decrease consumption of SSB.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.