Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From LNS Added to Complementary Foods

Not Applicable

Completed

• Conditions: Iron Deficiency
• Interventions: Dietary Supplement: Iron sulphate; Dietary Supplement: Iron pyrophosphate (FePP); Dietary Supplement: micronutrient powder; Dietary Supplement: micronutrient powder (containing FeSO4), phytase

• Registration Number: NCT01991626
• Lead Sponsor: Swiss Federal Institute of Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2013-11
• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-25
• Study Completion: 2014-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FeSO4- Emulsion before	Iron sulphate	Fat emulsion taken before a maize meal containing FeSO4
FePP-Emulsion mixed	Iron pyrophosphate (FePP)	Fat emulsion mixed to the meal containing FePP
MNP-control	micronutrient powder	maize meal containing micronutrient powder (MNP)
FeSO4 control	Iron sulphate	Maize meal containing FeSO4
FePP control	Iron pyrophosphate (FePP)	Maize meal containing FePP
FeSO4-Mixed	Iron sulphate	meals containing FeSO4 mixed with a fat emulsion
LNS-Phytase	micronutrient powder (containing FeSO4), phytase	Maize meal mixed with LNS containing micronutrient powder and phytase
LNS	micronutrient powder	Maize meal mixed with Lipid Nutrient Supplement (LNS) containing micronutrient powder
phytase	micronutrient powder (containing FeSO4), phytase	Maize meal containing micronutrient powder and phytase
FePP-Emulsion before	Iron pyrophosphate (FePP)	Fat emulsion taken before a meal containing FePP

Primary Outcome Measures

Name	Time	Method
Iron bio-availability from Oral Iron Supplements	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.