- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02455388
d13C Added Sugar Intake Biomarker: Determining Validity in Children
5 de febrero de 2019 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
370
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Virginia
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Blacksburg, Virginia, Estados Unidos, 24061
- Virginia Tech
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
6 años a 18 años (Niño, Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
delta13C Added Sugar Biomarker
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in d13C: delta13C Added Sugar Biomarker
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Brenda M Davy, Ph.D., Virginia Polytechnic Institute and State University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de abril de 2014
Finalización primaria (Actual)
1 de julio de 2016
Finalización del estudio (Actual)
1 de febrero de 2018
Fechas de registro del estudio
Enviado por primera vez
18 de mayo de 2015
Primero enviado que cumplió con los criterios de control de calidad
26 de mayo de 2015
Publicado por primera vez (Estimar)
27 de mayo de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de febrero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
5 de febrero de 2019
Última verificación
1 de febrero de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 1R21HD078636-01A1 (Subvención/contrato del NIH de EE. UU.)
- R21HD078636 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .