Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From LNS Added to Complementary Foods
1 other identifier
interventional
47
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 18, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedSeptember 23, 2015
September 1, 2015
2 months
November 18, 2013
September 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Iron bio-availability from Oral Iron Supplements
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
Study Arms (10)
LNS
OTHERMaize meal mixed with Lipid Nutrient Supplement (LNS) containing micronutrient powder
FePP-Emulsion mixed
OTHERFat emulsion mixed to the meal containing FePP
FeSO4-Mixed
OTHERmeals containing FeSO4 mixed with a fat emulsion
FePP-Emulsion before
OTHERFat emulsion taken before a meal containing FePP
FeSO4- Emulsion before
OTHERFat emulsion taken before a maize meal containing FeSO4
LNS-Phytase
OTHERMaize meal mixed with LNS containing micronutrient powder and phytase
phytase
OTHERMaize meal containing micronutrient powder and phytase
MNP-control
OTHERmaize meal containing micronutrient powder (MNP)
FePP control
OTHERMaize meal containing FePP
FeSO4 control
OTHERMaize meal containing FeSO4
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Monnard A, Moretti D, Zeder C, Steingotter A, Zimmermann MB. The effect of lipids, a lipid-rich ready-to-use therapeutic food, or a phytase on iron absorption from maize-based meals fortified with micronutrient powders. Am J Clin Nutr. 2017 Jun;105(6):1521-1527. doi: 10.3945/ajcn.116.142976. Epub 2017 May 3.
PMID: 28468891DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael B Zimmermann, Prof
ETH Zürich
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
November 18, 2013
First Posted
November 25, 2013
Study Start
September 1, 2013
Primary Completion
November 1, 2013
Study Completion
August 1, 2014
Last Updated
September 23, 2015
Record last verified: 2015-09