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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Ander: LNS
Maize meal mixed with Lipid Nutrient Supplement (LNS) containing micronutrient powder
|
|
|
Ander: FePP-Emulsion mixed
Fat emulsion mixed to the meal containing FePP
|
|
|
Ander: FeSO4-Mixed
meals containing FeSO4 mixed with a fat emulsion
|
|
|
Ander: FePP-Emulsion before
Fat emulsion taken before a meal containing FePP
|
|
|
Ander: FeSO4- Emulsion before
Fat emulsion taken before a maize meal containing FeSO4
|
|
|
Ander: LNS-Phytase
Maize meal mixed with LNS containing micronutrient powder and phytase
|
|
|
Ander: phytase
Maize meal containing micronutrient powder and phytase
|
|
|
Ander: MNP-control
maize meal containing micronutrient powder (MNP)
|
|
|
Ander: FePP control
Maize meal containing FePP
|
|
|
Ander: FeSO4 control
Maize meal containing FeSO4
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Iron bio-availability from Oral Iron Supplements
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Medewerkers
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Fe-LNS
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .