Unsweetened Sparkling Water and Changes in Sweetness Perception in Adolescents

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reducing Added Sugar Intake on Sweetness Perception in Adolescents by Substituting Unsweetened Sparkling Water for Sugar Sweetened Beverages

Conditions
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Obesity, Adolescent, PreDiabetes

Intervention / Treatment
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* Other: Unsweetened flavored sparkling water


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, before and after, cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Replacement of SSB with Unsweetened Sparkling Beverage<br>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. | Other: Unsweetened flavored sparkling water<br>* Unsweetened sparkling waters are carbonated water with flavoring, completely unsweetened, which are commercially available in soda-like flavors like cola<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 2 hour glucose concentration | Oral glucose tolerance testing; 1.75 g/kg body weight | 0, 12 weeks | 
| Change in Dietary consumption of SSB and Sparkling water | Using Technology Assisted Dietary Assessment (TADA) system, a mobile food record | 0, 2, 4, 6, 8, 10, 12 weeks | 
| Change in Insulin sensitivity | Whole body insulin sensitivity index (WBISI); Calculated as described by Matsuda et al., 1999. Units are 1/mg/dL*mU/ML*mg/dL*mU/ML; higher values indicate more insulin sensitivity | 0, 12 weeks | 
| Change in Glycemic variability | Continuous Glucose Monitoring will be measured usingFreeStyle Libre Pro System; Abbott; Abbott Park, IL. The instrument records glucose excursions during a 24 hour period as glycemic variability. | 0, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Flavor perception of beverage sweetness | Sensory testing of 6 levels of sweetness in beverages.Participants will rate the samples for their sweetness using a just about right visual analog scale, with anchors at: -100, Not sweet enough; -50, Slightly not sweet enough; 0, Just about right; +50, Slightly too sweet; and +100 Too sweet. Samples will also be rated for liking using a hedonic visual analog scale, with anchors at: -100, Worst ever; -50, Dislike; 0, Neutral; +50, Like; +100, Best ever. | 0, 12 weeks | 
| Change in Blood Pressure | Systolic blood pressure in the morning with participant in the fasting condition | 0, 12 weeks | 
| Change in Blood Triglycerides | Triglycerides concentrations in the morning with participant in the fasting condition. | 0, 12 weeks | 
| Change in waist circumference | measured per instructions from National Health and Nutrition Examination Survay (NHANES). Anthropometry Procedures Manual | 0, 12 weeks |