Unsweetened Sparkling Water and Changes in Sweetness Perception in Adolescents

NCT05966870 | Terminated Results

• 2 other identifiers: 1908757318P30DK097512
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Adolescent; PreDiabetes

Outcome Measures

Primary Outcomes (8)

• 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

  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).

  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.

  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.

  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.

  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).

  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.

  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.

  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)

  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)

  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)

  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)

  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)

  Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12)

Study Arms (1)

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.

Other: Unsweetened flavored sparkling water

Interventions

Unsweetened flavored sparkling water OTHER

Unsweetened sparkling waters are carbonated water with flavoring, completely unsweetened, which are commercially available in soda-like flavors like cola

Replacement of SSB with Unsweetened Sparkling Beverage

Eligibility Criteria

• Age: 10 Years - 21 Years
• Gender Eligibility Details: participant eligibility is based on self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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))

You may not qualify if:

• 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)

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Indiana University School of Public Health

Bloomington, Indiana, 47405, United States

Location

Related Publications (8)

• 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.

  PMID: 31790544 BACKGROUND

• Banfield 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.

  PMID: 26391469 BACKGROUND

• Reedy 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.

  PMID: 20869486 BACKGROUND

• Bailey 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.

  PMID: 29342109 BACKGROUND

• Boushey 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.

  PMID: 19190645 BACKGROUND

• Running, 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

• 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.

  PMID: 24198307 BACKGROUND

• Matsuda 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.

  PMID: 10480510 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity; Prediabetic State

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Because of the Covid-19 pandemic, data were not collected for the following outcomes: * Change in Dietary consumption of SSB and Sparkling water assessed with the TADA system * 2 hour Glucose Concentrations Measured Using 2 hour Oral Glucose Tolerance Testing * Fasting glucose and Hemoglobin A1C * Insulin Sensitivity measures (WBISI, IGI, and oDI) * Glycemic Control Measured Using Continuous Glucose Monitoring * CVD Outcomes (Blood Triglycerides, Blood Pressure and Waist Circumference)

Results Point of Contact

• Title: Nana Gletsu Miller
• Organization: Indiana University

ngletsum@indiana.edu

812-8557643

Study Officials

• Nana Gletsu Miller, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Prospective, before and after, cohort study

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: August 1, 2023
• Study Start: March 9, 2020
• Primary Completion: June 20, 2021
• Study Completion: June 20, 2021
• Last Updated: February 12, 2025
• Results First Posted: February 12, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)