Clinical trial NCT05966870: Unsweetened Sparkling Water and Changes in Sweetness Perception in Adolescents
Official title: Reducing Added Sugar Intake on Sweetness Perception in Adolescents by Substituting Unsweetened Sparkling Water for Sugar Sweetened Beverages
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity, Adolescent
PreDiabetes
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-08-01
Enrollment: 22
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, before and after, cohort study
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Dietary Consumption of SSB and Sparkling Water
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
measure: Change in 2 Hour Glucose Concentrations
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
measure: Change in Fasting Glucose
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
measure: Change in Hemoglobin A1c (HbA1c) Concentration
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
measure: Change in Whole-body Insulin Sensitivity Index (WBISI)
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
measure: Change in Insulinogenic Index (IGI)
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
measure: Change in Oral Disposition Index (oDI)
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
measure: Change in Glycemic Control
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Secondary outcomes:
measure: Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 0% (Weight Per Volume)
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
measure: Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 1.8% (Weight Per Volume)
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
measure: Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 2.8% (Weight Per Volume)
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
measure: Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 4.4% (Weight Per Volume)
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
measure: Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 6.8% (Weight Per Volume)
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
measure: Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 10.7% (Weight Per Volume)
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
measure: Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 0% (Weight Per Volume)
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
measure: Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 1.8% (Weight Per Volume)
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
measure: Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 2.8% (Weight Per Volume)
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
measure: Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 4.4% (Weight Per Volume)
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
measure: Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 6.8% (Weight Per Volume)
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
measure: Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 10.7% (Weight Per Volume)
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
measure: Change in Blood Triglycerides
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
measure: Change in Blood Pressure
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
measure: Change in Waist Circumference
timeFrame: Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University School of Public Health
state: Indiana
Study officials:
affiliation: Indiana University
name: Nana Gletsu Miller, PhD
role: PRINCIPAL_INVESTIGATOR
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