d13C Added Sugar Intake Biomarker: Determining Validity in Children
2 other identifiers
interventional
370
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 18, 2015
CompletedFirst Posted
Study publicly available on registry
May 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedResults Posted
Study results publicly available
July 27, 2018
CompletedFebruary 26, 2019
February 1, 2019
2.3 years
May 18, 2015
May 30, 2018
February 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
delta13C Added Sugar Biomarker
Validity, reliability, and sensitivity of the fingerstick blood d13C AS biomarker during cross-sectional data collection. Participants will provide 4 separate self-reported, record-assisted 24-hr food intake recalls, and at two of the visits, a fingerstick blood sample will be collected to analyze delta13C biomarker levels.
2-3 weeks
Secondary Outcomes (2)
Change in d13C: delta13C Added Sugar Biomarker
Two 7-day feeding periods, randomized order, with a four-week washout between feeding periods. Outcome is a change in d13C from day 1 to 8, for each feeding period.
Diagnostic Value of d13C Biomarker
2-3 weeks
Study Arms (3)
Low, then high added sugar diet
EXPERIMENTALParticipants will consume a low added sugar (5% total energy) diet for 7 consecutive days. After a 4-week washout period, participants will then consume a high added sugar (25% total energy) diet for 7 consecutive days.
High, then low added sugar diet
EXPERIMENTALParticipants will consume a high added sugar (25% total energy) diet for 7 consecutive days. After a 4-week washout period, participants will then consume a low added sugar (5% total energy) diet for 7 consecutive days
Dietary recall and fingerstick
NO INTERVENTIONParticipants will complete 4 in-person 24-hr dietary recalls and 2 fingerstick blood samples at Visit 1 and 3 within 3 weeks.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Cross-sectional study: Age 6-18, both genders
- Controlled feeding study: Age 12-18, both genders, BMI \<95%ile
You may not qualify if:
- Controlled feeding study: Food allergies and/or aversions, BMI\>95%ile
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Tech
Blacksburg, Virginia, 24061, United States
Related Publications (2)
MacDougall CR, Hill CE, Jahren AH, Savla J, Riebl SK, Hedrick VE, Raynor HA, Dunsmore JC, Frisard MI, Davy BM. The delta13C Value of Fingerstick Blood Is a Valid, Reliable, and Sensitive Biomarker of Sugar-Sweetened Beverage Intake in Children and Adolescents. J Nutr. 2018 Jan 1;148(1):147-152. doi: 10.1093/jn/nxx017.
PMID: 29378049DERIVEDMoore LB, Liu SV, Halliday TM, Neilson AP, Hedrick VE, Davy BM. Urinary Excretion of Sodium, Nitrogen, and Sugar Amounts Are Valid Biomarkers of Dietary Sodium, Protein, and High Sugar Intake in Nonobese Adolescents. J Nutr. 2017 Dec;147(12):2364-2373. doi: 10.3945/jn.117.256875. Epub 2017 Sep 20.
PMID: 28931586DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Brenda Davy
- Organization
- Virginia Tech
Study Officials
- PRINCIPAL INVESTIGATOR
Brenda M Davy, Ph.D.
Virginia Polytechnic Institute and State University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 18, 2015
First Posted
May 27, 2015
Study Start
April 1, 2014
Primary Completion
July 1, 2016
Study Completion
February 1, 2018
Last Updated
February 26, 2019
Results First Posted
July 27, 2018
Record last verified: 2019-02