Genetyczne predyspozycje do reaktywności na bodźce pokarmowe u dzieci
18 listopada 2024 zaktualizowane przez: Diane Gilbert-Diamond, Trustees of Dartmouth College
Związek czynników genetycznych, wskazówek żywieniowych i samoregulacji z nadmiernym spożyciem i otyłością u dzieci
W badaniu tym oceniano powiązania między czynnikami genetycznymi, reaktywnością neuronalną związaną z sygnałami pokarmowymi, zdolnością do samoregulacji, jedzeniem bez głodu (EAH) i przyrostem tkanki tłuszczowej u dzieci.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
Badacze ocenią powiązania między czynnikami genetycznymi, reaktywnością neuronalną związaną z sygnałami pokarmowymi, jedzeniem w przypadku braku głodu (EAH) w odpowiedzi na sygnały pokarmowe oraz przyrostem tkanki tłuszczowej u dzieci. Ustalą także, czy zdolność do samoregulacji modyfikuje te powiązania. Badane czynniki genetyczne obejmują w szczególności FTO, MC4R, polimorfizmy w genach zaangażowanych w szlaki dopaminergiczne oraz złożoną ocenę ryzyka genetycznego zbudowaną na podstawie loci związanych z otyłością obejmujących cały genom.
[14.03.2020]: Rekrutacja do badania tymczasowo wstrzymana ze względu na pandemię COVID-19
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
189
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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New Hampshire
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Lebanon, New Hampshire, Stany Zjednoczone, 03756
- Dartmouth-Hitchcock
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
8 lat do 12 lat (Dziecko)
Akceptuje zdrowych ochotników
Tak
Opis
Kryteria przyjęcia:
- Płynność języka angielskiego
- Chęć uczestnictwa we wszystkich wizytach studyjnych
Kryteria wyłączenia:
- Istotne alergie pokarmowe lub ograniczenia dietetyczne
- Metal w korpusie lub na nim
- Klaustrofobia
- Zaburzenia psychiczne i neurologiczne
- Krewny w badaniu
- Leki lub zaburzenia zmieniające apetyt lub uwagę
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: Reklamy żywności i fMRI
Ekspozycja na reklamy żywności podczas skanowania fMRI
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Ekspozycja na reklamy żywności umieszczone w programie telewizyjnym dostosowanym do wieku
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Pozorny komparator: Reklamy nieżywnościowe i fMRI
Ekspozycja na reklamy produktów innych niż spożywcze podczas skanowania fMRI
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Ekspozycja na reklamy produktów innych niż żywność umieszczone w programie telewizyjnym dostosowanym do wieku
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Aktywny komparator: Reklamy żywności i programy telewizyjne
Ekspozycja na reklamy żywności umieszczone w programie telewizyjnym dostosowanym do wieku
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Ekspozycja na reklamy żywności umieszczone w programie telewizyjnym dostosowanym do wieku
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Pozorny komparator: Reklamy i programy telewizyjne nieżywnościowe
Ekspozycja na reklamy produktów innych niż żywność umieszczone w programie telewizyjnym dostosowanym do wieku
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Ekspozycja na reklamy produktów innych niż żywność umieszczone w programie telewizyjnym dostosowanym do wieku
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Aktywność neuronowa związana z sygnałem pokarmowym
Ramy czasowe: Linia bazowa
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Aktywacja regionów nagrody w mózgu w odpowiedzi na sygnały pokarmowe i nieżywnościowe, mierzona różnicami w odpowiedzi zależnej od poziomu tlenu we krwi podczas skanów fMRI.
Badacze zbadają powiązania między polimorfizmami w FTO, MC4R, a także punktacją ryzyka genetycznego ze zróżnicowaną aktywnością neuronową.
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Linia bazowa
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Jedzenie na podstawie wskazówek pokarmowych w przypadku braku głodu (EAH)
Ramy czasowe: Wartość bazowa, 2 tygodnie, 4 tygodnie
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Różnica w kaloriach spożytych w odpowiedzi na pokarm i ekspozycję na bodźce nieżywnościowe w sesjach behawioralnych.
Badacze zbadają, w jaki sposób zróżnicowana aktywność neuronów w odpowiedzi na sygnały pokarmowe i nieżywnościowe będzie powiązana z EAH.
Badacze ocenią również, czy zdolność samoregulacji zmniejsza powiązanie między zróżnicowaną aktywnością neuronową a EAH.
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Wartość bazowa, 2 tygodnie, 4 tygodnie
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Zmiana BMI
Ramy czasowe: Wartość wyjściowa, obserwacja 1 rok
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Różnica pomiędzy wskaźnikiem BMI z-score według krzywych referencyjnych wzrostu 2000 Centrum Kontroli Chorób, ocenianych na początku badania i w okresie kontrolnym.
Badacze ocenią powiązania między czynnikami genetycznymi (polimorfizmy w FTO, MC4R i punktacja ryzyka genetycznej otyłości), aktywnością neuronową związaną z sygnałami pokarmowymi i EAH ze zmianą BMI.
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Wartość wyjściowa, obserwacja 1 rok
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Diane Gilbert-Diamond, ScD, Dartmouth-Hitchcock Medical Center
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
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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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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
10 stycznia 2019
Zakończenie podstawowe (Rzeczywisty)
27 marca 2024
Ukończenie studiów (Rzeczywisty)
27 marca 2024
Daty rejestracji na studia
Pierwszy przesłany
4 grudnia 2018
Pierwszy przesłany, który spełnia kryteria kontroli jakości
4 grudnia 2018
Pierwszy wysłany (Rzeczywisty)
6 grudnia 2018
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
21 listopada 2024
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
18 listopada 2024
Ostatnia weryfikacja
1 listopada 2024
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- D19064
- 1R01HD092604 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .