Obesity, AdolescentNCT05966870
Unsweetened Sparkling Water and Changes in Sweetness Perception in Adolescents
A study testing Unsweetened flavored sparkling water in people with Obesity, Adolescent and PreDiabetes, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Obesity, Adolescent, PreDiabetes
- What is being tested?
- Unsweetened flavored sparkling water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2020to 20 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female adolescents (age 10-21 years)
- Overweight and Obese (body mass index ≥ 85 percentile for age and sex)
- High consumers of SSB, defined as >2 or more servings per day
- Family history of diabetes in a first or second degree relative OR prediabetes (i.e., evidence of either impaired glucose tolerance (HbA1c 5.7 - 6.4%, or plasma glucose between 140-199 mg/dL at 2 hours on oral glucose tolerance testing) or impaired fasting plasma glucose (≥ 100 mg/dL))
Who cannot join
- Use of medications that affect glucose metabolism (such as glucocorticoid-containing medications or atypical antipsychotics). We will not exclude female participants who currently use, are planning to use, or planning to stop taking oral contraceptives.
- Syndromic obesity (such as Prader Willi, hypothalamic obesity, or Laurence-Moon-Biedl)
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Public Health
Bloomington, Indiana, 47405
About this study
Official title: Reducing Added Sugar Intake on Sweetness Perception in Adolescents by Substituting Unsweetened Sparkling Water for Sugar Sweetened Beverages
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.
Read the detailed description
Importance of studying added sugars in adolescents. Research that leads to nutritional strategies to prevent T2D in adolescents is an urgent pursuit. One particular contributing factor to the growth of T2D and prediabetes in adolescents is the increased consumption of added sugars. Adolescents in the U.S. have high intakes of added sugars which could have poor health implications. Added sugars are found in sugar sweetened beverages and desserts and snacks, top sources of energy for adolescents, and calories from added sugars contribute to 16% of the total energy intake. Levels are well above recommendations from leading scientific organizations, which suggest limiting added sugars to less than 10% of energy. However, it is not clear whether sugar reduction to less than 10% of energy is palatable for an adolescent population that prefers sweetened foods and beverages. Moreover, uncertainty about the evidence linking added sugar consumption to risk of disease has made policies that seek to reduce dietary intake of added sugar controversial. The controversy impairs large-scale implementation of recommendations to reduce intake of added sugars by individuals, clinicians, policy makers and industry stakeholders.
Evidence linking added sugars and risk of type 2 diabetes and cardiovascular disease lacks information on adolescents. Many epidemiological studies in adults, but not all show the concept that after controlling for energy intake, high consumption of sugar-sweetened foods is a risk factor for T2D. Epidemiological studies also associate high consumption of added sugars, particularly from sugar sweetened beverages (SSB), with increased adiposity (including central adiposity) and dyslipidemia. These studies formed the basis of recommendations to limit added sugar consumption from the American Heart Organization. The data in youth is limited. Two small randomized studies compared the effects of glucose versus fructose beverages on insulin sensitivity in adolescents and findings were mixed. One longitudinal cohort study showed that higher consumption of added sugars, from SSB, was associated with hyperglycemia and impaired insulin sensitivity in youth aged 8 - 12 years. One study showed that high amounts of added sugars may induce insulin resistance and beta-cell dysfunction and such effects can occur independent of adiposity. The literature lacks evidence linking high consumption of added sugars to risk of developing youth-onset T2D.
Substituting Flavored Sparkling Water for Sugar Sweetened Beverages. Instead of sugar, food manufacturers typically sweeten foods beverages using low-calorie or artificial sweeteners. "Diet" versions of SSB have been available for several decades and are widely used by adults and children. However the safety of low calorie sweeteners is controversial and many in the scientific and lay communities do not promote their use as a substitute for SSB. We propose that an alternative to SSB may be found in sparkling waters (carbonated water with flavoring, completely unsweetened), which are commercially available in soda-like flavors like cola or Dr. Pepper™. The rationale for the current project is the urgent need for an effective strategy to combat adolescent T2D which investigators will address by demonstrating the benefit of an intervention to reduce added sugars. The objective of the study is to demonstrate whether substituting sparkling water for SSB has benefits for in vivo physiological measures of glycemia while maintaining flavor acceptability to adolescents who are at risk for diabetes.
- Conditions
- Obesity, Adolescent, PreDiabetes
- Being tested
- Unsweetened flavored sparkling water
- Medical subject headings
- Pediatric Obesity, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unsweetened flavored sparkling waterOther
Unsweetened sparkling waters are carbonated water with flavoring, completely unsweetened, which are commercially available in soda-like flavors like cola
| Study group | Role | What they receive |
|---|---|---|
| Replacement of SSB with Unsweetened Sparkling Beverage | Experimental | To encourage participants to substitute sparkling water flavored water for SSB intake, we will provide enough supplies of the drinks to adolescents (and their families) each month. We will also provide iPhones with the TADA app to the adolescent participants. Study staff will remind participants to consume the sparkling water through iMessages sent through the TADA app. Receives: Other: Unsweetened flavored sparkling water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dietary Consumption of SSB and Sparkling Water
Dietary consumption of SSB and Sparkling water were assessed using Technology Assisted Dietary Assessment (TADA) system, a mobile food record
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in 2 Hour Glucose Concentrations
Oral glucose tolerance testing will be performed in the morning after participants have undergone an overnight fast for 8 hours at baseline and Week 12. Blood samples will be obtained at -15, 0, 15, 30, 60, 90,120 minutes, relative to ingestion of a glucose drink at a dose of 1.75 g/kg body weight (maximum 75 g glucose).
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Fasting Glucose
Fasting glucose will be measured after overnight fast for 8 hours, just prior to the initiation of the baseline oral glucose tolerance testing at Baseline and Week 12.
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Hemoglobin A1c (HbA1c) Concentration
HbA1c will be measured just prior to the initiation of the oral glucose tolerance testing at baseline and Week 12.
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Whole-body Insulin Sensitivity Index (WBISI)
For measures of insulin action, which takes into account serum glucose and insulin concentrations, serum fractions from the oral glucose tolerance tests will be frozen at -80 degrees C until analysis. The inverse of fasting insulin (1/fasting insulin) will be used as a surrogate estimate of whole-body insulin sensitivity.
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Insulinogenic Index (IGI)
For measures of insulin action, which takes into account serum glucose and insulin concentrations, serum fractions from the oral glucose tolerance tests will be frozen at -80 degrees C until analysis. Early phase insulin secretion during the OGTT will be expressed as the insulinogenic index (IGI) or the ratio of the incremental response of insulin to glucose at 30 minutes of the OGTT (IGI30).
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Oral Disposition Index (oDI)
For measures of insulin action, which takes into account serum glucose and insulin concentrations, serum fractions from the oral glucose tolerance tests will be frozen at -80 degrees C until analysis. The oDI will be calculated as IGI30 × 1/fasting insulin.
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Glycemic Control
We will collect free-living, glucose measures for 6 consecutive days using the Continuous Glucose Monitoring (CGM; FreeStyle Libre Pro System; Abbott; Abbott Park, IL). The CGM will be administered to participants 6 days before the start of Week 0 and Week 12, and the monitor will be removed at the clinic visit. For the placement of the CGM, the back of the participant's upper arm will be cleaned with an alcohol wipe and dried. The sensor will be firmly adhered to the arm with the needle application inserted. The FreeStyle sensor measures glucose every 15 sec and records an average glucose value every 15 min for up to 14 days.
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Secondary outcomes (15)
Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 0% (Weight Per Volume)
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.
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 1.8% (Weight Per Volume)
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.
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 2.8% (Weight Per Volume)
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.
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 4.4% (Weight Per Volume)
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.
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 6.8% (Weight Per Volume)
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.
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 10.7% (Weight Per Volume)
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.
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 0% (Weight Per Volume)
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".
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 1.8% (Weight Per Volume)
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".
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 2.8% (Weight Per Volume)
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".
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 4.4% (Weight Per Volume)
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".
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 6.8% (Weight Per Volume)
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".
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 10.7% (Weight Per Volume)
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".
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Blood Triglycerides
Plasma triglyceride concentration will be measured.
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Blood Pressure
Blood pressure will be measured after 5 minutes of rest, on the right arm in the supine position.
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Waist Circumference
The distance around the waist will be measured.
Measured: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start9 Mar 2020
- Primary completion20 Jun 2021
- Study completion20 Jun 2021
Why it stopped: Because this study was initiated during the COVID pandemic, several outcome measures (including those requiring in-person assessments) were abandoned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Obesity, AdolescentStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, before and after, cohort study
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nana Gletsu Miller, Indiana University
- Investigators
- Nana Gletsu Miller, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966870
- Sponsor's protocol ID
- 1908757318
- Other IDs
- P30DK097512
- Status last verified
- Jan 2025
- First submitted
- 10 Jul 2023
- Last updated
- 12 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31790544Banfield 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.
PubMed 26391469Reedy 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.
PubMed 20869486Bailey 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.
PubMed 29342109Boushey 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.
PubMed 19190645Running, C.A. Desensitization but not sensitization from commercial chemesthetic beverages. Food Quality and Preference 2018 Vol. 69 Pages 21-27; DOI: 10.1016/j.foodqual.2018.05.001
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.
PubMed 24198307Matsuda 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.
PubMed 10480510
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Added Sugar Intake on Sweetness Perception in Adolescents by Substituting Unsweetened Sparkling Water for Sugar Sweetened Beverages
- ClinicalTrials.gov ID
- NCT05966870
- Acronym / sponsor ID
- 1908757318
- Conditions
- Obesity, Adolescent, PreDiabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because this study was initiated during the COVID pandemic, several outcome measures (including those requiring in-person assessments) were abandoned.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Posted 12 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Importance of studying added sugars in adolescents. Research that leads to nutritional strategies to prevent T2D in adolescents is an urgent pursuit. One particular contributing factor to the growth of T2D and prediabetes in adolescents is the increased consumption of added sugars. Adolescents in the U.S. have high intakes of added sugars which could have poor health implications. Added sugars are found in sugar sweetened beverages and desserts and snacks, top sources of energy for adolescents, and calories from added sugars contribute to 16% of the total energy intake. Levels are well above recommendations from leading scientific organizations, which suggest limiting added sugars to less than 10% of energy. However, it is not clear whether sugar reduction to less than 10% of energy is palatable for an adolescent population that prefers sweetened foods and beverages. Moreover, uncertainty about the evidence linking added sugar consumption to risk of disease has made policies that seek to reduce dietary intake of added sugar controversial. The controversy impairs large-scale implementation of recommendations to reduce intake of added sugars by individuals, clinicians, policy makers and industry stakeholders.
Evidence linking added sugars and risk of type 2 diabetes and cardiovascular disease lacks information on adolescents. Many epidemiological studies in adults, but not all show the concept that after controlling for energy intake, high consumption of sugar-sweetened foods is a risk factor for T2D. Epidemiological studies also associate high consumption of added sugars, particularly from sugar sweetened beverages (SSB), with increased adiposity (including central adiposity) and dyslipidemia. These studies formed the basis of recommendations to limit added sugar consumption from the American Heart Organization. The data in youth is limited. Two small randomized studies compared the effects of glucose versus fructose beverages on insulin sensitivity in adolescents and findings were mixed. One longitudinal cohort study showed that higher consumption of added sugars, from SSB, was associated with hyperglycemia and impaired insulin sensitivity in youth aged 8 - 12 years. One study showed that high amounts of added sugars may induce insulin resistance and beta-cell dysfunction and such effects can occur independent of adiposity. The literature lacks evidence linking high consumption of added sugars to risk of developing youth-onset T2D.
Substituting Flavored Sparkling Water for Sugar Sweetened Beverages. Instead of sugar, food manufacturers typically sweeten foods beverages using low-calorie or artificial sweeteners. "Diet" versions of SSB have been available for several decades and are widely used by adults and children. However the safety of low calorie sweeteners is controversial and many in the scientific and lay communities do not promote their use as a substitute for SSB. We propose that an alternative to SSB may be found in sparkling waters (carbonated water with flavoring, completely unsweetened), which are commercially available in soda-like flavors like cola or Dr. Pepper™. The rationale for the current project is the urgent need for an effective strategy to combat adolescent T2D which investigators will address by demonstrating the benefit of an intervention to reduce added sugars. The objective of the study is to demonstrate whether substituting sparkling water for SSB has benefits for in vivo physiological measures of glycemia while maintaining flavor acceptability to adolescents who are at risk for diabetes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, before and after, cohort study
| Arm | Type | Receives |
|---|---|---|
| Replacement of SSB with Unsweetened Sparkling Beverage | Experimental | Other: Unsweetened flavored sparkling waterTo encourage participants to substitute sparkling water flavored water for SSB intake, we will provide enough supplies of the drinks to adolescents (and their families) each month. We will also provide iPhones with the TADA app to the adolescent participants. Study staff will remind participants to consume the sparkling water through iMessages sent through the TADA app. |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male and female adolescents (age 10-21 years)
- Overweight and Obese (body mass index ≥ 85 percentile for age and sex)
- High consumers of SSB, defined as >2 or more servings per day
- Family history of diabetes in a first or second degree relative OR prediabetes (i.e., evidence of either impaired glucose tolerance (HbA1c 5.7 - 6.4%, or plasma glucose between 140-199 mg/dL at 2 hours on oral glucose tolerance testing) or impaired fasting plasma glucose (≥ 100 mg/dL))
Key exclusion criteria (2 listed)
- Use of medications that affect glucose metabolism (such as glucocorticoid-containing medications or atypical antipsychotics). We will not exclude female participants who currently use, are planning to use, or planning to stop taking oral contraceptives.
- Syndromic obesity (such as Prader Willi, hypothalamic obesity, or Laurence-Moon-Biedl)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unsweetened flavored sparkling waterUnsweetened sparkling waters are carbonated water with flavoring, completely unsweetened, which are commercially available in soda-like flavors like cola | Other | Replacement of SSB with Unsweetened Sparkling Beverage |
Primary outcome
Change in Dietary Consumption of SSB and Sparkling Water
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Dietary consumption of SSB and Sparkling water were assessed using Technology Assisted Dietary Assessment (TADA) system, a mobile food record
Change in 2 Hour Glucose Concentrations
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Oral glucose tolerance testing will be performed in the morning after participants have undergone an overnight fast for 8 hours at baseline and Week 12. Blood samples will be obtained at -15, 0, 15, 30, 60, 90,120 minutes, relative to ingestion of a glucose drink at a dose of 1.75 g/kg body weight (maximum 75 g glucose).
Change in Fasting Glucose
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Fasting glucose will be measured after overnight fast for 8 hours, just prior to the initiation of the baseline oral glucose tolerance testing at Baseline and Week 12.
Change in Hemoglobin A1c (HbA1c) Concentration
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
HbA1c will be measured just prior to the initiation of the oral glucose tolerance testing at baseline and Week 12.
Change in Whole-body Insulin Sensitivity Index (WBISI)
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
For measures of insulin action, which takes into account serum glucose and insulin concentrations, serum fractions from the oral glucose tolerance tests will be frozen at -80 degrees C until analysis. The inverse of fasting insulin (1/fasting insulin) will be used as a surrogate estimate of whole-body insulin sensitivity.
Change in Insulinogenic Index (IGI)
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
For measures of insulin action, which takes into account serum glucose and insulin concentrations, serum fractions from the oral glucose tolerance tests will be frozen at -80 degrees C until analysis. Early phase insulin secretion during the OGTT will be expressed as the insulinogenic index (IGI) or the ratio of the incremental response of insulin to glucose at 30 minutes of the OGTT (IGI30).
Change in Oral Disposition Index (oDI)
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
For measures of insulin action, which takes into account serum glucose and insulin concentrations, serum fractions from the oral glucose tolerance tests will be frozen at -80 degrees C until analysis. The oDI will be calculated as IGI30 × 1/fasting insulin.
Change in Glycemic Control
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
We will collect free-living, glucose measures for 6 consecutive days using the Continuous Glucose Monitoring (CGM; FreeStyle Libre Pro System; Abbott; Abbott Park, IL). The CGM will be administered to participants 6 days before the start of Week 0 and Week 12, and the monitor will be removed at the clinic visit. For the placement of the CGM, the back of the participant's upper arm will be cleaned with an alcohol wipe and dried. The sensor will be firmly adhered to the arm with the needle application inserted. The FreeStyle sensor measures glucose every 15 sec and records an average glucose value every 15 min for up to 14 days.
15 secondary outcomes
Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 0% (Weight Per Volume)
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 1.8% (Weight Per Volume)
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 2.8% (Weight Per Volume)
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 4.4% (Weight Per Volume)
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 6.8% (Weight Per Volume)
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 10.7% (Weight Per Volume)
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 0% (Weight Per Volume)
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 1.8% (Weight Per Volume)
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 2.8% (Weight Per Volume)
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 4.4% (Weight Per Volume)
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 6.8% (Weight Per Volume)
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 10.7% (Weight Per Volume)
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Blood Triglycerides
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Blood Pressure
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Change in Waist Circumference
Time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31790544Andes 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.
- Background: PubMed 26391469Banfield 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.
- Background: PubMed 20869486Reedy 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.
- Background: PubMed 29342109Bailey 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.
- Background: PubMed 19190645Boushey 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.
- BackgroundRunning, C.A. Desensitization but not sensitization from commercial chemesthetic beverages. Food Quality and Preference 2018 Vol. 69 Pages 21-27; DOI: 10.1016/j.foodqual.2018.05.001
- Background: PubMed 24198307Wang 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.
- Background: PubMed 10480510Matsuda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nana Gletsu Miller, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unsweetened flavored sparkling water in people with Obesity, Adolescent and PreDiabetes, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dietary Consumption of SSB and Sparkling Water (time frame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05966870, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.