- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02455388
d13C Added Sugar Intake Biomarker: Determining Validity in Children
5. Februar 2019 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
370
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Virginia
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Blacksburg, Virginia, Vereinigte Staaten, 24061
- Virginia Tech
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
6 Jahre bis 18 Jahre (Kind, Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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.
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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.
|
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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.
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Kein Eingriff: 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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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delta13C Added Sugar Biomarker
Zeitfenster: 2-3 weeks
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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.
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2-3 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in d13C: delta13C Added Sugar Biomarker
Zeitfenster: 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.
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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.
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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.
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Diagnostic Value of d13C Biomarker
Zeitfenster: 2-3 weeks
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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.
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2-3 weeks
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: Brenda M Davy, Ph.D., Virginia Polytechnic Institute and State University
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. April 2014
Primärer Abschluss (Tatsächlich)
1. Juli 2016
Studienabschluss (Tatsächlich)
1. Februar 2018
Studienanmeldedaten
Zuerst eingereicht
18. Mai 2015
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
26. Mai 2015
Zuerst gepostet (Schätzen)
27. Mai 2015
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
26. Februar 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
5. Februar 2019
Zuletzt verifiziert
1. Februar 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 1R21HD078636-01A1 (US NIH Stipendium/Vertrag)
- R21HD078636 (US NIH Stipendium/Vertrag)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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