- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01784198
Determination of Protein Requirements in Pregnancy
Determination of Protein Requirements in Healthy Pregnant Women Using Indicator Amino Acid Oxidation Technique
Protein is an essential part of our diet. It is used to build muscle and body tissue, send signals throughout our body and to support the immune system. Dietary protein is even more crucial during pregnancy as it is needed for healthy growth and development of the baby. There is very minimal data available on how much additional protein is required during pregnancy. Current recommendations are based on older techniques such as nitrogen balance studies of non-pregnant adults and minimally based on pregnancy specific data. There is no scientific information regarding the amount of protein needed during different stages of pregnancy.
The investigators hypothesize that the current recommendations of protein intake during pregnancy are underestimated.
The goal of this study is to measure protein requirement in healthy pregnant women (19-35y)using a more quick and modern technique called the indicator amino acid oxidation technique (IAAO).
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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British Columbia
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Vancouver, British Columbia, Canada, V5Z4H4
- Child & Family Research Institute
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:Healthy pregnant women
- Singleton pregnancy
- Maternal age 19-35y
- In good health (free of chronic/acute disease,full range of physical mobility)
- Healthy pre-pregnancy body mass index
Exclusion Criteria:Women
- not pregnant
- Pregnant with more than one child
- Singleton pregnancy outside the age range of 19-35y
- Not in good health or have a metabolic, neurological, genetic, or immune disorder, including gestational diabetes or anemia
- smoke or consume alcohol during their pregnancy
- classified as underweight (<18.5 kg/m2), overweight (25-30 kg/m2) or obese (>30 kg/m2)
- allergic to eggs and egg protein
- severe nausea/vomiting throughout their pregnancy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Protein Intake
Dietary supplement:Protein intake
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Oral consumption of Eight hourly experimental meals- Includes 4 tracer-free experimental meals containing a mixture of free amino acids, calories from a flavored liquid and protein free cookies and 4- labeled amino acid experimental meals.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
13 Carbon dioxide production
Tidsramme: 8 hours (1 study day)
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Urine and breath samples will be collected during the study to measure the rate of oxidation of tracer in expired breath and flux by enrichment in urine.
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8 hours (1 study day)
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Rajavel Elango, Ph.D, Child & Family Research Institute/University of British Columbia
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- H11-00070
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Kliniske forsøg med Graviditet
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King's College Hospital NHS TrustEuropean Association for the Study of the LiverRekrutteringCirrhose, lever | HELLP syndrom | Intrahepatisk kolestase af graviditet | Graviditetssygdom | AFLP - Acute Fatty Lever of PregnancyDet Forenede Kongerige
Kliniske forsøg med Protein Intake
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Anglia Ruskin UniversityDanone Nutricia ResearchRekrutteringGastrointestinal dysfunktion | AminosyreændringDet Forenede Kongerige
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USDA Grand Forks Human Nutrition Research CenterAktiv, ikke rekrutterendeFedmeForenede Stater
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Pennington Biomedical Research CenterAfsluttet
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University of AarhusArla Foods; Mejeribrugets ForskningsFond; Innovation foundationAfsluttetProteinmetabolismeDanmark
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Purdue UniversityAfsluttet
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USDA Grand Forks Human Nutrition Research CenterNorth Dakota Beef CommissionAfsluttet
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Arne AstrupAfsluttetUndersøgelsesfokus: AppetitDanmark
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University of KielAfsluttet
-
University of UtahAfsluttet
-
University of ExeterAfsluttetSund og raskDet Forenede Kongerige