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- Essai clinique NCT02455388
d13C Added Sugar Intake Biomarker: Determining Validity in Children
5 février 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
370
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Virginia
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Blacksburg, Virginia, États-Unis, 24061
- Virginia Tech
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
6 ans à 18 ans (Enfant, Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
|
|
Expérimental: 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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Aucune 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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delta13C Added Sugar Biomarker
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in d13C: delta13C Added Sugar Biomarker
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Brenda M Davy, Ph.D., Virginia Polytechnic Institute and State University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 avril 2014
Achèvement primaire (Réel)
1 juillet 2016
Achèvement de l'étude (Réel)
1 février 2018
Dates d'inscription aux études
Première soumission
18 mai 2015
Première soumission répondant aux critères de contrôle qualité
26 mai 2015
Première publication (Estimation)
27 mai 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 février 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 février 2019
Dernière vérification
1 février 2019
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 1R21HD078636-01A1 (Subvention/contrat des NIH des États-Unis)
- R21HD078636 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .