Genetisk predisposisjon for matsignalreaktivitet hos barn
18. november 2024 oppdatert av: Diane Gilbert-Diamond, Trustees of Dartmouth College
Forholdet mellom genetiske faktorer, matsignaler og selvregulering med overforbruk og fett hos barn
Denne studien vurderer assosiasjonene mellom genetiske faktorer, matrelatert nevral reaktivitet, selvregulerende kapasitet, spising i fravær av sult (EAH) og overvekt hos barn.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Etterforskerne vil vurdere assosiasjonene mellom genetiske faktorer, matrelatert nevral reaktivitet, spising i fravær av sult (EAH) som svar på matsignaler, og overvekt hos barn. De vil også avgjøre om selvregulerende kapasitet endrer disse assosiasjonene. De genetiske faktorene som spesifikt utforskes inkluderer FTO, MC4R, polymorfismer i gener involvert i dopaminerge veier, og en sammensatt genetisk risikoscore bygget fra genomomfattende fedme-relaterte loci.
[3/14/2020]: Studierekruttering midlertidig stoppet på grunn av COVID-19-pandemien
Studietype
Intervensjonell
Registrering (Faktiske)
189
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New Hampshire
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Lebanon, New Hampshire, Forente stater, 03756
- Dartmouth-Hitchcock
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
8 år til 12 år (Barn)
Tar imot friske frivillige
Ja
Beskrivelse
Inklusjonskriterier:
- Engelsk flytende
- Vilje til å delta på alle studiebesøk
Ekskluderingskriterier:
- Relevante matallergier eller diettrestriksjoner
- Metall i eller på kroppen
- Klaustrofobi
- Psykiatriske og nevrologiske lidelser
- Pårørende i studiet
- Appetitt- eller oppmerksomhetsendrende medisiner eller lidelser
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Matannonser og fMRI
Eksponering for matannonser under en fMRI-skanning
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Eksponering for matannonser innebygd i et alderstilpasset TV-program
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Sham-komparator: Annonser for ikke-mat og fMRI
Eksponering for ikke-mat-annonser under en fMRI-skanning
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Eksponering for ikke-mat-annonser innebygd i et alderstilpasset TV-program
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Aktiv komparator: Matannonser og TV-program
Eksponering for matannonser innebygd i et alderstilpasset TV-program
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Eksponering for matannonser innebygd i et alderstilpasset TV-program
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Sham-komparator: Annonser for ikke-mat og TV-program
Eksponering for ikke-mat-annonser innebygd i et alderstilpasset TV-program
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Eksponering for ikke-mat-annonser innebygd i et alderstilpasset TV-program
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Food-cue-relatert nevral aktivitet
Tidsramme: Grunnlinje
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Aktivering i hjernebelønningsregioner som respons på mat og ikke-mat-signaler, målt ved forskjeller i blod-oksygennivåavhengig respons under fMRI-skanninger.
Etterforskere vil undersøke assosiasjoner mellom polymorfismer i FTO, MC4R, samt en genetisk risikoscore med den differensielle nevrale aktiviteten.
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Grunnlinje
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Food-cue-relatert spising i fravær av sult (EAH)
Tidsramme: Baseline, 2 uker, 4 uker
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Forskjell i kcal konsumert som respons på mat og ikke-mat-eksponering i atferdsøktene.
Etterforskere vil undersøke hvordan differensiell nevral aktivitet som respons på mat kontra ikke-mat-signaler vil relatere seg til EAH.
Etterforskere vil også vurdere om selvregulerende kapasitet reduserer denne sammenhengen mellom differensiell nevral aktivitet og EAH.
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Baseline, 2 uker, 4 uker
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Endring i BMI
Tidsramme: Baseline, 1 års oppfølging
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Forskjellen mellom BMI z-score i henhold til Center for DiseaSe Control 2000 Growth Reference Curves vurdert ved baseline og oppfølging.
Etterforskere vil vurdere assosiasjonene mellom genetiske faktorer (polymorfismer i FTO, MC4R; og en genetisk fedmerisikoscore), matrelatert nevral aktivitet og EAH med endring i BMI.
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Baseline, 1 års oppfølging
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Diane Gilbert-Diamond, ScD, Dartmouth-Hitchcock Medical Center
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
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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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- Graff M, Scott RA, Justice AE, Young KL, Feitosa MF, Barata L, Winkler TW, Chu AY, Mahajan A, Hadley D, Xue L, Workalemahu T, Heard-Costa NL, den Hoed M, Ahluwalia TS, Qi Q, Ngwa JS, Renstrom F, Quaye L, Eicher JD, Hayes JE, Cornelis M, Kutalik Z, Lim E, Luan J, Huffman JE, Zhang W, Zhao W, Griffin PJ, Haller T, Ahmad S, Marques-Vidal PM, Bien S, Yengo L, Teumer A, Smith AV, Kumari M, Harder MN, Justesen JM, Kleber ME, Hollensted M, Lohman K, Rivera NV, Whitfield JB, Zhao JH, Stringham HM, Lyytikainen LP, Huppertz C, Willemsen G, Peyrot WJ, Wu Y, Kristiansson K, Demirkan A, Fornage M, Hassinen M, Bielak LF, Cadby G, Tanaka T, Magi R, van der Most PJ, Jackson AU, Bragg-Gresham JL, Vitart V, Marten J, Navarro P, Bellis C, Pasko D, Johansson A, Snitker S, Cheng YC, Eriksson J, Lim U, Aadahl M, Adair LS, Amin N, Balkau B, Auvinen J, Beilby J, Bergman RN, Bergmann S, Bertoni AG, Blangero J, Bonnefond A, Bonnycastle LL, Borja JB, Brage S, Busonero F, Buyske S, Campbell H, Chines PS, Collins FS, Corre T, Smith GD, Delgado GE, Dueker N, Dorr M, Ebeling T, Eiriksdottir G, Esko T, Faul JD, Fu M, Faerch K, Gieger C, Glaser S, Gong J, Gordon-Larsen P, Grallert H, Grammer TB, Grarup N, van Grootheest G, Harald K, Hastie ND, Havulinna AS, Hernandez D, Hindorff L, Hocking LJ, Holmens OL, Holzapfel C, Hottenga JJ, Huang J, Huang T, Hui J, Huth C, Hutri-Kahonen N, James AL, Jansson JO, Jhun MA, Juonala M, Kinnunen L, Koistinen HA, Kolcic I, Komulainen P, Kuusisto J, Kvaloy K, Kahonen M, Lakka TA, Launer LJ, Lehne B, Lindgren CM, Lorentzon M, Luben R, Marre M, Milaneschi Y, Monda KL, Montgomery GW, De Moor MHM, Mulas A, Muller-Nurasyid M, Musk AW, Mannikko R, Mannisto S, Narisu N, Nauck M, Nettleton JA, Nolte IM, Oldehinkel AJ, Olden M, Ong KK, Padmanabhan S, Paternoster L, Perez J, Perola M, Peters A, Peters U, Peyser PA, Prokopenko I, Puolijoki H, Raitakari OT, Rankinen T, Rasmussen-Torvik LJ, Rawal R, Ridker PM, Rose LM, Rudan I, Sarti C, Sarzynski MA, Savonen K, Scott WR, Sanna S, Shuldiner AR, Sidney S, Silbernagel G, Smith BH, Smith JA, Snieder H, Stancakova A, Sternfeld B, Swift AJ, Tammelin T, Tan ST, Thorand B, Thuillier D, Vandenput L, Vestergaard H, van Vliet-Ostaptchouk JV, Vohl MC, Volker U, Waeber G, Walker M, Wild S, Wong A, Wright AF, Zillikens MC, Zubair N, Haiman CA, Lemarchand L, Gyllensten U, Ohlsson C, Hofman A, Rivadeneira F, Uitterlinden AG, Perusse L, Wilson JF, Hayward C, Polasek O, Cucca F, Hveem K, Hartman CA, Tonjes A, Bandinelli S, Palmer LJ, Kardia SLR, Rauramaa R, Sorensen TIA, Tuomilehto J, Salomaa V, Penninx BWJH, de Geus EJC, Boomsma DI, Lehtimaki T, Mangino M, Laakso M, Bouchard C, Martin NG, Kuh D, Liu Y, Linneberg A, Marz W, Strauch K, Kivimaki M, Harris TB, Gudnason V, Volzke H, Qi L, Jarvelin MR, Chambers JC, Kooner JS, Froguel P, Kooperberg C, Vollenweider P, Hallmans G, Hansen T, Pedersen O, Metspalu A, Wareham NJ, Langenberg C, Weir DR, Porteous DJ, Boerwinkle E, Chasman DI; CHARGE Consortium; EPIC-InterAct Consortium; PAGE Consortium; Abecasis GR, Barroso I, McCarthy MI, Frayling TM, O'Connell JR, van Duijn CM, Boehnke M, Heid IM, Mohlke KL, Strachan DP, Fox CS, Liu CT, Hirschhorn JN, Klein RJ, Johnson AD, Borecki IB, Franks PW, North KE, Cupples LA, Loos RJF, Kilpelainen TO. Genome-wide physical activity interactions in adiposity - A meta-analysis of 200,452 adults. PLoS Genet. 2017 Apr 27;13(4):e1006528. doi: 10.1371/journal.pgen.1006528. eCollection 2017 Apr. Erratum In: PLoS Genet. 2017 Aug 23;13(8):e1006972. doi: 10.1371/journal.pgen.1006972.
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
10. januar 2019
Primær fullføring (Faktiske)
27. mars 2024
Studiet fullført (Faktiske)
27. mars 2024
Datoer for studieregistrering
Først innsendt
4. desember 2018
Først innsendt som oppfylte QC-kriteriene
4. desember 2018
Først lagt ut (Faktiske)
6. desember 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. november 2024
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. november 2024
Sist bekreftet
1. november 2024
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- D19064
- 1R01HD092604 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .