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d13C Added Sugar Intake Biomarker: Determining Validity in Children

NCT02455388 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2019-02-26

Study results available
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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.

Conditions

  • Validation Studies

Interventions

DIETARY_SUPPLEMENT

High added sugar diet

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.

DIETARY_SUPPLEMENT

Low added sugar diet

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.

Sponsors & Collaborators

  • University of Hawaii

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Virginia Polytechnic Institute and State University

    lead OTHER

Principal Investigators

  • Brenda M Davy, Ph.D. · Virginia Polytechnic Institute and State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-07-31
Completion
2018-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02455388 on ClinicalTrials.gov