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Completed

NCT Number: NCT02455388

d13C Added Sugar Intake Biomarker: Determining Validity in Children

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Tech

Blacksburg, Virginia, 24061, United States

About this study

Consumption of energy-containing added sugars (AS) and in particular, sugar-sweetened beverages (SSB), have been suggested as contributors to weight gain. In children and adolescents, total AS intake represents ~16% of total energy, or ~300-400 kcal/d; SSB comprise ~50% of total AS intake. Although recognized by major health organizations, the role of AS and their primary food source, SSB, in the development and progression of obesity and related co-morbidities remains controversial. A common research limitation in this area is a reliance on self-reported measures of dietary intake, which present additional challenges when studying children. Thus, the need for objective methods to assess dietary intake, such as biomarkers of AS consumption, has been recognized. The investigators have established the validity of the fingerstick blood d13C AS biomarker in adults, and aim to expand our innovative biomarker to studies of diet in children. The investigators propose to establish the validity and reliability of the fingerstick blood d13C AS biomarker in children using two approaches. First, a controlled feeding component (Study 1) will provide data necessary for validation of the biomarker with actual AS intake, and determine its ability to detect levels of AS intake. Second, a cross-sectional component (Study 2) will compare the biomarker to self-reported intake data, collected in a method similar to national nutritional surveillance methodology (i.e., NHANES). Study 1 will include 30 adolescents aged 12-18 yrs, who will consume both a high AS (25% total energy) and low AS (5% total energy) diet for 7 days each, in a random order. Study 2 will include 325 children aged 6-18 yrs, who will complete five laboratory sessions. Record- assisted 24-hr dietary recalls will be completed at four of the sessions to assess habitual AS intake, and fingerstick blood samples will be obtained at two of the sessions. The potential confounding effects of non- sweetener corn and animal product consumption will be addressed in both studies by quantifying non- sweetener corn consumption in the controlled diets (Study 1) and in self-reported dietary recalls (Study 2), and by assessing the nitrogen stable isotope composition d15N of fingerstick samples. To advance existing knowledge of dietary assessment approaches, urinary sugars and urine d13C will be assessed in Study 1, which will permit a direct comparison of biomarkers - existing (urinary sucrose, fructose) and novel (urine and fingerstick d13C ). The role of AS in health has been contentious for decades, and the reliance on self-reported intake data is an often-cited flaw in this area. Our findings could significantly advance research addressing the health impacts of AS intake in children and adolescents.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cross-sectional study: Age 6-18, both genders
  • Controlled feeding study: Age 12-18, both genders, BMI <95%ile

Exclusion criteria

  • Controlled feeding study: Food allergies and/or aversions, BMI>95%ile

Treatment and study plan

High added sugar diet

Dietary Supplement

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 diet

Dietary Supplement

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.

Primary outcomes

  1. delta13C Added Sugar Biomarker

    Time frame: 2-3 weeks

    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.

Secondary outcomes

  1. Change in d13C: delta13C Added Sugar Biomarker

    Time frame: 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.

    Validity, reliability and sensitivity of the fingerstick blood delta13C AS biomarker during feeding study. Participants are provided 7 days of food with high or low added sugar diet. Blood samples will be obtained each day via fingerstick to analyze delta13C biomarker levels.

  2. Diagnostic Value of d13C Biomarker

    Time frame: 2-3 weeks

    Determine diagnostic value of d13C biomarker using fingerstick blood. The area under the ROC was used as a measure for the diagnostic accuracy of the d13C biomarker, with values closer to 1.0 indicating greater ability to distinguish between low and high added sugar and sugar sweetened beverage consumers.

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Collaborators

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

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
May 27, 2015
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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