d13C Added Sugar Intake Biomarker: Determining Validity in Children

Validation Studies Clinical Trial

Official title:

d13C Added Sugar Intake Biomarker: Determining Validity in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02455388
• Other study ID #: 1R21HD078636-01A1
• Secondary ID: R21HD078636
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: February 2018

Study information

• Verified date: February 2019
• Source: Virginia Polytechnic Institute and State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: February 2018
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Validation Studies

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Virginia Tech	Blacksburg	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Hawaii

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in d13C: delta13C Added Sugar Biomarker	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.	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.
Secondary	Diagnostic Value of d13C Biomarker	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.	2-3 weeks