Status:
TERMINATED
Unsweetened Sparkling Water and Changes in Sweetness Perception in Adolescents
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity, Adolescent
PreDiabetes
Eligibility:
All Genders
10-21 years
Phase:
NA
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 ...
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 o...
Eligibility Criteria
Inclusion
- 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
- • 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)
Key Trial Info
Start Date :
March 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2021
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05966870
Start Date
March 9 2020
End Date
June 20 2021
Last Update
February 12 2025
Active Locations (1)
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1
Indiana University School of Public Health
Bloomington, Indiana, United States, 47405