Glycogen Metabolism in Children
25. januar 2022 opdateret af: Nestlé
Measurement of Glycogen Replenishment in Children After an Overnight Fast
It is not fully understood in children how much of hepatic and muscle glycogen is used during a night and how they are replenished after a breakfast.
This study aims to analyze the glycogen metabolism before and after an overnight sleep as well as after a breakfast in children between 8 and 12 years old.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The aim of the study is to investigate if liver and muscle glycogen stores are depleted in children after overnight fasting and to what extend the stores are replenished with the intake of small breakfast.
The study is a balanced incomplete crossover design. Participants (children between 8 and 12 years old) have to be two periods of two days in the study. They will be randomized in 6 arms, receiving either water, 1 serving of a small breakfast (Breakfast 1) or 2 servings of the small breakfast (Breakfast 2).
An Interim Analysis after 9 completed subjects will be performed in order to calculate the total number of subjects needed to adequately power the Primary Endpoint.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
24
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Nottingham, Det Forenede Kongerige, NG7 2RD
- University of Nottingham Medical School
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
8 år til 12 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Healthy girls and boys between 8 and 12 years of age
- Clinically healthy body weight (5 to 85th rounded percentile from UK)
- In good health as determined by health screening questionnaires
- English proficiency as per investigator judgment
- Informed consent signed by parent(s), or legal representative if applicable and signed child assent according to local legislation
Exclusion Criteria:
- Girls having menstruations
- Any type of self-reported food allergies
- Lactose intolerance
- Claustrophobic
- Diagnosis of Diabetes Mellitus
- Diagnosed acute or chronic medical conditions that could impact study outcomes (asthma)
- Ongoing diseases or intake of any prescribed or over the counter drugs
- Participants or participants' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol (including a consumption of 200 ml study drink)
- Currently participating or having participated in another clinical trial within 12 weeks prior to trial start.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Breakfast 1 - Breakfast 2
Participants will receive Breakfast 1 then Breakfast 2.
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Participant will receive Breakfast 1
Participant will receive Breakfast 2
|
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Eksperimentel: Breakfast 1 - water
Participants will receive Breakfast 1, then water.
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Participant will receive Breakfast 1
Participant will receive water
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Eksperimentel: Breakfast 2 - water
Participants will receive Breakfast 2, then water.
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Participant will receive Breakfast 2
Participant will receive water
|
|
Eksperimentel: Breakfast 2 - Breakfast 1
Participants will receive 2 servings, then 1 serving of the study product.
|
Participant will receive Breakfast 1
Participant will receive Breakfast 2
|
|
Eksperimentel: Water - Breakfast 1
Participants will receive water, then Breakfast 1.
|
Participant will receive Breakfast 1
Participant will receive water
|
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Eksperimentel: Water - Breakfast 2
Participants will receive water, then Breakfast 2.
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Participant will receive Breakfast 2
Participant will receive water
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incremental/decremental AUC0-240 of the concentration/time curve of hepatic glycogen
Tidsramme: 4 hours
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To determine the effects of 1 and 2 servings of a small breakfast on hepatic glycogen stores; measured by NMR
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4 hours
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change of hepatic glycogen content over an overnight fast
Tidsramme: 12 hours
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Change of hepatic glycogen content over an overnight fast
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12 hours
|
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Change of muscle glycogen content over an overnight fast
Tidsramme: 12 hours
|
Change of muscle glycogen content over an overnight fast
|
12 hours
|
|
Incremental/decremental AUC0-240 of the concentration/time curve of muscle glycogen
Tidsramme: 4 hours
|
To determine the effects of 1 and 2 servings of a small breakfast on muscle glycogen stores; measured by NMR
|
4 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Liz Simpson, PhD, University of Nottingham Medical School
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
23. januar 2020
Primær færdiggørelse (Faktiske)
30. november 2021
Studieafslutning (Faktiske)
30. november 2021
Datoer for studieregistrering
Først indsendt
18. februar 2020
Først indsendt, der opfyldte QC-kriterier
18. februar 2020
Først opslået (Faktiske)
20. februar 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. januar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. januar 2022
Sidst verificeret
1. januar 2022
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 1906NRC
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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