Predisposición genética a la reactividad de las señales alimentarias en niños
18 de noviembre de 2024 actualizado por: Diane Gilbert-Diamond, Trustees of Dartmouth College
La relación de los factores genéticos, las señales alimentarias y la autorregulación con el consumo excesivo y la adiposidad en los niños
Este estudio evalúa las asociaciones entre factores genéticos, reactividad neuronal relacionada con las señales alimentarias, capacidad de autorregulación, comer en ausencia de hambre (EAH) y aumento de adiposidad en niños.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Los investigadores evaluarán las asociaciones entre factores genéticos, reactividad neuronal relacionada con las señales alimentarias, comer en ausencia de hambre (EAH) en respuesta a las señales alimentarias y aumento de adiposidad en los niños. También determinarán si la capacidad de autorregulación modifica estas asociaciones. Los factores genéticos explorados específicamente incluyen FTO, MC4R, polimorfismos en genes implicados en las vías dopaminérgicas y una puntuación de riesgo genético compuesta construida a partir de loci relacionados con la obesidad en todo el genoma.
[14/03/2020]: El reclutamiento del estudio se detuvo temporalmente debido a la pandemia de COVID-19
Tipo de estudio
Intervencionista
Inscripción (Actual)
189
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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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth-Hitchcock
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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
8 años a 12 años (Niño)
Acepta Voluntarios Saludables
Sí
Descripción
Criterios de inclusión:
- fluidez en inglés
- Voluntad de participar en todas las visitas de estudio.
Criterio de exclusión:
- Alergias alimentarias relevantes o restricciones dietéticas.
- Metal dentro o sobre el cuerpo.
- Claustrofobia
- Trastornos psiquiátricos y neurológicos.
- Pariente en el estudio
- Medicamentos o trastornos que alteran el apetito o la atención.
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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Comparador activo: Anuncios de alimentos y resonancia magnética funcional
Exposición a anuncios de alimentos durante una exploración por resonancia magnética funcional
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Exposición a anuncios de alimentos integrados en un programa de televisión apropiado para la edad
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Comparador falso: Anuncios no alimentarios y resonancia magnética funcional
Exposición a anuncios no alimentarios durante una exploración por resonancia magnética funcional
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Exposición a anuncios no alimentarios integrados en un programa de televisión apropiado para la edad
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Comparador activo: Anuncios de comida y programa de televisión.
Exposición a anuncios de comida integrados en un programa de televisión apropiado para su edad.
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Exposición a anuncios de alimentos integrados en un programa de televisión apropiado para la edad
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Comparador falso: Anuncios no alimentarios y programas de televisión
Exposición a anuncios no alimentarios integrados en un programa de televisión apropiado para la edad
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Exposición a anuncios no alimentarios integrados en un programa de televisión apropiado para la edad
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Actividad neuronal relacionada con las señales alimentarias
Periodo de tiempo: Base
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Activación en las regiones de recompensa del cerebro en respuesta a señales alimentarias versus no alimentarias, medida por las diferencias en la respuesta dependiente del nivel de oxígeno en sangre durante las exploraciones por resonancia magnética funcional.
Los investigadores examinarán las asociaciones entre polimorfismos en FTO, MC4R, así como una puntuación de riesgo genético con la actividad neuronal diferencial.
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Base
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Alimentación relacionada con señales alimentarias en ausencia de hambre (EAH)
Periodo de tiempo: Línea de base, 2 semanas, 4 semanas
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Diferencia en kcal consumidas en respuesta a la exposición a señales alimentarias versus no alimentarias en las sesiones conductuales.
Los investigadores examinarán cómo la actividad neuronal diferencial en respuesta a señales alimentarias versus no alimentarias se relacionará con la EAH.
Los investigadores también evaluarán si la capacidad de autorregulación disminuye esta asociación entre la actividad neuronal diferencial y la EAH.
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Línea de base, 2 semanas, 4 semanas
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Cambio en el IMC
Periodo de tiempo: Valor inicial, seguimiento al año
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Diferencia entre la puntuación z del IMC según las curvas de referencia de crecimiento de 2000 del Center for DiseaSe Control evaluadas al inicio y en el seguimiento.
Los investigadores evaluarán las asociaciones entre factores genéticos (polimorfismos en FTO, MC4R; y una puntuación de riesgo de obesidad genética), actividad neuronal relacionada con las señales alimentarias y EAH con cambios en el IMC.
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Valor inicial, seguimiento al año
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Diane Gilbert-Diamond, ScD, Dartmouth-Hitchcock Medical Center
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
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LifeLines Cohort Study; Brennan EP, Choi M, Dastani Z, Drong AW, Eriksson P, Franco-Cereceda A, Gadin JR, Gharavi AG, Goddard ME, Handsaker RE, Huang J, Karpe F, Kathiresan S, Keildson S, Kiryluk K, Kubo M, Lee JY, Liang L, Lifton RP, Ma B, McCarroll SA, McKnight AJ, Min JL, Moffatt MF, Montgomery GW, Murabito JM, Nicholson G, Nyholt DR, Okada Y, Perry JRB, Dorajoo R, Reinmaa E, Salem RM, Sandholm N, Scott RA, Stolk L, Takahashi A, Tanaka T, van 't Hooft FM, Vinkhuyzen AAE, Westra HJ, Zheng W, Zondervan KT; ADIPOGen Consortium; AGEN-BMI Working Group; CARDIOGRAMplusC4D Consortium; CKDGen Consortium; GLGC; ICBP; MAGIC Investigators; MuTHER Consortium; MIGen Consortium; PAGE Consortium; ReproGen Consortium; GENIE Consortium; International Endogene Consortium; Heath AC, Arveiler D, Bakker SJL, Beilby J, Bergman RN, Blangero J, Bovet P, Campbell H, Caulfield MJ, Cesana G, Chakravarti A, Chasman DI, Chines PS, Collins FS, Crawford DC, Cupples LA, Cusi D, Danesh J, de Faire U, den Ruijter HM, Dominiczak AF, Erbel R, Erdmann J, Eriksson JG, Farrall M, Felix SB, Ferrannini E, Ferrieres J, Ford I, Forouhi NG, Forrester T, Franco OH, Gansevoort RT, Gejman PV, Gieger C, Gottesman O, Gudnason V, Gyllensten U, Hall AS, Harris TB, Hattersley AT, Hicks AA, Hindorff LA, Hingorani AD, Hofman A, Homuth G, Hovingh GK, Humphries SE, Hunt SC, Hypponen E, Illig T, Jacobs KB, Jarvelin MR, Jockel KH, Johansen B, Jousilahti P, Jukema JW, Jula AM, Kaprio J, Kastelein JJP, Keinanen-Kiukaanniemi SM, Kiemeney LA, Knekt P, Kooner JS, Kooperberg C, Kovacs P, Kraja AT, Kumari M, Kuusisto J, Lakka TA, Langenberg C, Marchand LL, Lehtimaki T, Lyssenko V, Mannisto S, Marette A, Matise TC, McKenzie CA, McKnight B, Moll FL, Morris AD, Morris AP, Murray JC, Nelis M, Ohlsson C, Oldehinkel AJ, Ong KK, Madden PAF, Pasterkamp G, Peden JF, Peters A, Postma DS, Pramstaller PP, Price JF, Qi L, Raitakari OT, Rankinen T, Rao DC, Rice TK, Ridker PM, Rioux JD, Ritchie MD, Rudan I, Salomaa V, Samani NJ, Saramies J, Sarzynski MA, Schunkert H, Schwarz PEH, Sever P, Shuldiner AR, Sinisalo J, Stolk RP, Strauch K, Tonjes A, Tregouet DA, Tremblay A, Tremoli E, Virtamo J, Vohl MC, Volker U, Waeber G, Willemsen G, Witteman JC, Zillikens MC, Adair LS, Amouyel P, Asselbergs FW, Assimes TL, Bochud M, Boehm BO, Boerwinkle E, Bornstein SR, Bottinger EP, Bouchard C, Cauchi S, Chambers JC, Chanock SJ, Cooper RS, de Bakker PIW, Dedoussis G, Ferrucci L, Franks PW, Froguel P, Groop LC, Haiman CA, Hamsten A, Hui J, Hunter DJ, Hveem K, Kaplan RC, Kivimaki M, Kuh D, Laakso M, Liu Y, Martin NG, Marz W, Melbye M, Metspalu A, Moebus S, Munroe PB, Njolstad I, Oostra BA, Palmer CNA, Pedersen NL, Perola M, Perusse L, Peters U, Power C, Quertermous T, Rauramaa R, Rivadeneira F, Saaristo TE, Saleheen D, Sattar N, Schadt EE, Schlessinger D, Slagboom PE, Snieder H, Spector TD, Thorsteinsdottir U, Stumvoll M, Tuomilehto J, Uitterlinden AG, Uusitupa M, van der Harst P, Walker M, Wallaschofski H, Wareham NJ, Watkins H, Weir DR, Wichmann HE, Wilson JF, Zanen P, Borecki IB, Deloukas P, Fox CS, Heid IM, O'Connell JR, Strachan DP, Stefansson K, van Duijn CM, Abecasis GR, Franke L, Frayling TM, McCarthy MI, Visscher PM, Scherag A, Willer CJ, Boehnke M, Mohlke KL, Lindgren CM, Beckmann JS, Barroso I, North KE, Ingelsson E, Hirschhorn JN, Loos RJF, Speliotes EK. Genetic studies of body mass index yield new insights for obesity biology. Nature. 2015 Feb 12;518(7538):197-206. doi: 10.1038/nature14177.
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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)
10 de enero de 2019
Finalización primaria (Actual)
27 de marzo de 2024
Finalización del estudio (Actual)
27 de marzo de 2024
Fechas de registro del estudio
Enviado por primera vez
4 de diciembre de 2018
Primero enviado que cumplió con los criterios de control de calidad
4 de diciembre de 2018
Publicado por primera vez (Actual)
6 de diciembre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de noviembre de 2024
Última actualización enviada que cumplió con los criterios de control de calidad
18 de noviembre de 2024
Última verificación
1 de noviembre de 2024
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- D19064
- 1R01HD092604 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .