Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From Lipid Nutrient Supplements Added to Complementary Foods
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 47
- Primary Endpoint
- Iron bio-availability from Oral Iron Supplements
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
FePP-Emulsion mixed
Fat emulsion mixed to the meal containing FePP
Intervention: Iron pyrophosphate (FePP) (Dietary Supplement)
LNS
Maize meal mixed with Lipid Nutrient Supplement (LNS) containing micronutrient powder
Intervention: micronutrient powder (Dietary Supplement)
FePP-Emulsion before
Fat emulsion taken before a meal containing FePP
Intervention: Iron pyrophosphate (FePP) (Dietary Supplement)
LNS-Phytase
Maize meal mixed with LNS containing micronutrient powder and phytase
Intervention: micronutrient powder (containing FeSO4), phytase (Dietary Supplement)
phytase
Maize meal containing micronutrient powder and phytase
Intervention: micronutrient powder (containing FeSO4), phytase (Dietary Supplement)
MNP-control
maize meal containing micronutrient powder (MNP)
Intervention: micronutrient powder (Dietary Supplement)
FePP control
Maize meal containing FePP
Intervention: Iron pyrophosphate (FePP) (Dietary Supplement)
FeSO4 control
Maize meal containing FeSO4
Intervention: Iron sulphate (Dietary Supplement)
FeSO4- Emulsion before
Fat emulsion taken before a maize meal containing FeSO4
Intervention: Iron sulphate (Dietary Supplement)
FeSO4-Mixed
meals containing FeSO4 mixed with a fat emulsion
Intervention: Iron sulphate (Dietary Supplement)
Outcomes
Primary Outcomes
Iron bio-availability from Oral Iron Supplements
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Prof. Michael B. Zimmermann
Prof
Swiss Federal Institute of Technology