CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 370 enrolled
Drug / intervention
High added sugar diet +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02455388
NCT02455388N/ACompleted
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d13C Added Sugar Intake Biomarker: Determining Validity in Children

Virginia Polytechnic Institute and State University·interventional·Posted May 27, 2015·Updated Feb 26, 2019

In Brief

A clinical study evaluating High added sugar diet and Low added sugar diet for Validation Studies. Completed, enrolled 370 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsValidation Studies
CountriesUnited States
CollaboratorsUniversity of Hawaii, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 27, 2015
Enrollment StartApr 1, 2014
Primary CompletionJul 1, 2016
Study CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.1 years ago

Interventions

High added sugar dietdietary

Controlled feeding study. Participants will be provided with daily coolers containing foods with high (25%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning.

Low added sugar dietdietary

Controlled feeding study. Participants will be provided with daily coolers containing foods with low (5%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning.