- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01991626
Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From LNS Added to Complementary Foods
Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From Lipid Nutrient Supplements Added to Complementary Foods
Previous studies on iron absorption have focused on the effects on the addition of iron absorption enhancers like ascorbic acid and EDTA to a meal and more recently the enzymatic phytic acid removal through phytase. The investigators want here to investigate the effects of fat on iron absorption with and without the addition of exogenous phytase as a potential iron absorption enhancer in lipid nutrient supplements (LNS) products compared to micronutrient powder(MNP) products.
Furthermore the investigators will evaluate the effects of Lipids- on iron absorption to induce the ileal brake by ingestion of a fat emulsion prior to a meal. Increasing the caloric density of a meal by increasing its fat content might enhance iron absorption by delaying gastric emptying, gastric acid secretion and increasing Fe stomach residence time.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Reproductive age females 18-45 years
- Normal body mass index (17.5-25 kg/m2)
- No intake of mineral/vitamin supplements 2 weeks before and during the study
- No metabolic or gastrointestinal disorders
- No food allergies or other chronic disorders or eating disorders assessed by self-report
- Having received full oral and written information about the aims and procedures of the study
- Willing to comply with the study procedure
- Having provided oral and written informed consent
Exclusion Criteria:
- Regular intake of medication (except oral contraceptives)
- Blood donation or significant blood loss (accident, surgery) over the past 4 months
- Currently participating in another clinical trial or having participated in another clinical trial during the last 30 days prior to the beginning of this study
- Former participation in a study involving administration of iron stable isotopes
- Subject who cannot be expected to comply with study protocol
- Pregnancy or lactation
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: LNS
Maize meal mixed with Lipid Nutrient Supplement (LNS) containing micronutrient powder
|
|
|
Annen: FePP-Emulsion mixed
Fat emulsion mixed to the meal containing FePP
|
|
|
Annen: FeSO4-Mixed
meals containing FeSO4 mixed with a fat emulsion
|
|
|
Annen: FePP-Emulsion before
Fat emulsion taken before a meal containing FePP
|
|
|
Annen: FeSO4- Emulsion before
Fat emulsion taken before a maize meal containing FeSO4
|
|
|
Annen: LNS-Phytase
Maize meal mixed with LNS containing micronutrient powder and phytase
|
|
|
Annen: phytase
Maize meal containing micronutrient powder and phytase
|
|
|
Annen: MNP-control
maize meal containing micronutrient powder (MNP)
|
|
|
Annen: FePP control
Maize meal containing FePP
|
|
|
Annen: FeSO4 control
Maize meal containing FeSO4
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Iron bio-availability from Oral Iron Supplements
Tidsramme: 14 days
|
Iron bioavailability will be assessed with stable isotopic labels.
The shift in the isotopic ratio in human whole blood 14 days after administration will be measured with mass spectrometry.
|
14 days
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Fe-LNS
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