d13C Added Sugar Intake Biomarker: Determining Validity in Children

NCT ID: NCT02455388

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 370 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2018-02-28

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.

Conditions

Validation Studies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Low, then high added sugar diet

Participants 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.

Group Type: EXPERIMENTAL

High added sugar diet

Intervention Type: 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

Intervention Type: 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.

High, then low added sugar diet

Participants 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

Group Type: EXPERIMENTAL

High added sugar diet

Intervention Type: 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

Intervention Type: 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.

Dietary recall and fingerstick

Participants will complete 4 in-person 24-hr dietary recalls and 2 fingerstick blood samples at Visit 1 and 3 within 3 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Hawaii

OTHER

Sponsor Role: collaborator

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

NIH

Sponsor Role: collaborator

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: lead

Responsible Party

Brenda Davy

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brenda M Davy, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Virginia Polytechnic Institute and State University

Locations

Virginia Tech

Blacksburg, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29378049 (View on PubMed)

Moore 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.

Reference Type: DERIVED

PMID: 28931586 (View on PubMed)

Other Identifiers

R21HD078636

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R21HD078636-01A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link