N/A
N=370
d13C Added Sugar Intake Biomarker: Determining Validity in Children
Validation Studies
Bottom Line
View on ClinicalTrials.gov: NCT02455388 ↗Enrolled (actual)
370
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: delta13C Added Sugar Biomarker — -19.66; -19.64 ‰ δ13C — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High added sugar diet (Dietary_supplement); Low added sugar diet (Dietary_supplement)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- Virginia Polytechnic Institute and State University
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY delta13C Added Sugar Biomarker |
-19.66; -19.64 | <0.001 sig |
| SECONDARY Change in d13C: delta13C Added Sugar Biomarker |
-0.05; 0.03 | <0.05 sig |
| SECONDARY Diagnostic Value of d13C Biomarker |
0.61 | <0.01 sig |
Summary
Added sugars (AS) constitute a significant source (~ 16%) of the total daily calories consumed by youth. The role of AS in health is contentious, and the reliance on self-reported dietary data is an often-cited flaw in existing research. The investigators propose to establish the validity of the d13C biomarker for AS intake from fingerstick blood samples in children; our findings could significantly advance research addressing the health impacts of AS intake in children and adolescents.
Eligibility Criteria
Inclusion Criteria
- Cross-sectional study: Age 6-18, both genders
- Controlled feeding study: Age 12-18, both genders, BMI 95%ile
Data sourced from ClinicalTrials.gov (NCT02455388). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.