Unsweetened Sparkling Water and Changes in Sweetness Perception in Adolescents

Not Applicable

Terminated

Conditions: Obesity, Adolescent
PreDiabetes

Interventions: Other: Unsweetened flavored sparkling water

Registration Number: NCT05966870

Lead Sponsor: Indiana University

Brief 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. 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 22

Inclusion Criteria

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))

Exclusion Criteria

• Pregnancy

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Replacement of SSB with Unsweetened Sparkling Beverage	Unsweetened flavored sparkling water	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.

Primary Outcome Measures

Name	Time	Method
Change in Dietary Consumption of SSB and Sparkling Water	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	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 Hemoglobin A1c (HbA1c) Concentration	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 Fasting Glucose	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 Oral Disposition Index (oDI)	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 Whole-body Insulin Sensitivity Index (WBISI)	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)	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 Glycemic Control	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.

Secondary Outcome Measures

Name	Time	Method
Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 1.8% (Weight Per Volume)	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.
Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 0% (Weight Per Volume)	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.
Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 2.8% (Weight Per Volume)	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.
Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 4.4% (Weight Per Volume)	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.
Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 0% (Weight Per Volume)	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".
Change in Blood Pressure	Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)	Blood pressure will be measured after 5 minutes of rest, on the right arm in the supine position.
Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 6.8% (Weight Per Volume)	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.
Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 10.7% (Weight Per Volume)	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.
Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 1.8% (Weight Per Volume)	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".
Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 2.8% (Weight Per Volume)	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".
Change in Blood Triglycerides	Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)	Plasma triglyceride concentration will be measured.
Change in Waist Circumference	Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)	The distance around the waist will be measured.
Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 4.4% (Weight Per Volume)	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".
Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 6.8% (Weight Per Volume)	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".
Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 10.7% (Weight Per Volume)	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".