- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02455388
d13C Added Sugar Intake Biomarker: Determining Validity in Children
February 5, 2019 updated by: Brenda Davy, Virginia Polytechnic Institute and State University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
370
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Blacksburg, Virginia, United States, 24061
- Virginia Tech
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Experimental: 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
|
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.
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2-3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
2-3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Brenda M Davy, Ph.D., Virginia Polytechnic Institute and State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2014
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
February 1, 2018
Study Registration Dates
First Submitted
May 18, 2015
First Submitted That Met QC Criteria
May 26, 2015
First Posted (Estimate)
May 27, 2015
Study Record Updates
Last Update Posted (Actual)
February 26, 2019
Last Update Submitted That Met QC Criteria
February 5, 2019
Last Verified
February 1, 2019
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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