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d13C Added Sugar Intake Biomarker: Determining Validity in Children

d13C Added Sugar Intake Biomarker: Determining Validity in Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02455388
Enrollment
370
Registered
2015-05-27
Start date
2014-04-30
Completion date
2018-02-28
Last updated
2019-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Validation Studies

Keywords

Nutrition, Obesity, Pediatric

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.

Detailed 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.

Interventions

DIETARY_SUPPLEMENTHigh 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_SUPPLEMENTLow 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

University of Hawaii
CollaboratorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Virginia Polytechnic Institute and State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention model description

Study 1: Crossover design Study 2: Cross-sectional design

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
delta13C Added Sugar Biomarker2-3 weeksValidity, 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

MeasureTime frameDescription
Change in d13C: delta13C Added Sugar BiomarkerTwo 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.
Diagnostic Value of d13C Biomarker2-3 weeksDetermine 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.

Countries

United States

Participant flow

Pre-assignment details

No significant events took place in the study after enrollment but prior to arm assignment.

Participants by arm

ArmCount
Controlled Feeding Study
Participants will be randomly assigned to consume either a high (25% total energy) or low (5% total energy) added sugar diet for the first 7 consecutive day period. After a 4-week washout period, participants will then consume the other diet for another period of 7 consecutive days. 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.
32
Cross-sectional Study
Participants will complete 4 in-person 24-hr dietary recalls within 3 weeks and 2 fingerstick blood samples at Visit 1 and 3.
326
Total358

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyProtocol Violation104
Overall StudyWithdrawal by Subject007

Baseline characteristics

CharacteristicControlled Feeding StudyCross-sectional StudyTotal
Age, Categorical
<=18 years
32 Participants326 Participants358 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous15.3 years
STANDARD_DEVIATION 1.6
12 years
STANDARD_DEVIATION 3
12.6 years
STANDARD_DEVIATION 3.3
Body Mass Index20.2 kg/m^2
STANDARD_DEVIATION 2.1
20.0 kg/m^2
STANDARD_DEVIATION 4.5
20.0 kg/m^2
STANDARD_DEVIATION 4.4
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants6 Participants6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
31 Participants303 Participants334 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants17 Participants18 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants7 Participants7 Participants
Race (NIH/OMB)
Black or African American
0 Participants3 Participants3 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants3 Participants3 Participants
Race (NIH/OMB)
White
32 Participants313 Participants345 Participants
Region of Enrollment
United States
32 participants326 participants358 participants
Sex: Female, Male
Female
17 Participants167 Participants184 Participants
Sex: Female, Male
Male
15 Participants159 Participants174 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 180 / 170 / 337
other
Total, other adverse events
0 / 180 / 150 / 337
serious
Total, serious adverse events
0 / 180 / 150 / 337

Outcome results

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.

Time frame: 2-3 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Cross-sectional Studydelta13C Added Sugar BiomarkerVisit 1-19.66 ‰ δ13CStandard Deviation 0.68
Cross-sectional Studydelta13C Added Sugar BiomarkerVisit 3-19.64 ‰ δ13CStandard Deviation 0.68
p-value: <0.001Intraclass correlation coefficient
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.

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.

Population: Adolescents aged 12-18 years with a body mass index percentile \<95%. They were willing to follow a controlled diet and did not have food allergies, intolerances or aversions.

ArmMeasureValue (MEAN)Dispersion
Cross-sectional StudyChange in d13C: delta13C Added Sugar Biomarker-0.05Standard Deviation 0.071
High Added Sugar DietChange in d13C: delta13C Added Sugar Biomarker0.03Standard Deviation 0.083
p-value: <0.05ANOVA
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.

Time frame: 2-3 weeks

ArmMeasureValue (NUMBER)
Cross-sectional StudyDiagnostic Value of d13C Biomarker0.61 Area under the ROC curve
p-value: <0.01Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026