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

NCT ID: NCT01991626

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-08-31

Brief Summary

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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

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Conditions

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Iron Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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LNS

Maize meal mixed with Lipid Nutrient Supplement (LNS) containing micronutrient powder

Group Type OTHER

micronutrient powder

Intervention Type DIETARY_SUPPLEMENT

FePP-Emulsion mixed

Fat emulsion mixed to the meal containing FePP

Group Type OTHER

Iron pyrophosphate (FePP)

Intervention Type DIETARY_SUPPLEMENT

FeSO4-Mixed

meals containing FeSO4 mixed with a fat emulsion

Group Type OTHER

Iron sulphate

Intervention Type DIETARY_SUPPLEMENT

FePP-Emulsion before

Fat emulsion taken before a meal containing FePP

Group Type OTHER

Iron pyrophosphate (FePP)

Intervention Type DIETARY_SUPPLEMENT

FeSO4- Emulsion before

Fat emulsion taken before a maize meal containing FeSO4

Group Type OTHER

Iron sulphate

Intervention Type DIETARY_SUPPLEMENT

LNS-Phytase

Maize meal mixed with LNS containing micronutrient powder and phytase

Group Type OTHER

micronutrient powder (containing FeSO4), phytase

Intervention Type DIETARY_SUPPLEMENT

phytase

Maize meal containing micronutrient powder and phytase

Group Type OTHER

micronutrient powder (containing FeSO4), phytase

Intervention Type DIETARY_SUPPLEMENT

MNP-control

maize meal containing micronutrient powder (MNP)

Group Type OTHER

micronutrient powder

Intervention Type DIETARY_SUPPLEMENT

FePP control

Maize meal containing FePP

Group Type OTHER

Iron pyrophosphate (FePP)

Intervention Type DIETARY_SUPPLEMENT

FeSO4 control

Maize meal containing FeSO4

Group Type OTHER

Iron sulphate

Intervention Type DIETARY_SUPPLEMENT

Interventions

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micronutrient powder

Intervention Type DIETARY_SUPPLEMENT

micronutrient powder (containing FeSO4), phytase

Intervention Type DIETARY_SUPPLEMENT

Iron pyrophosphate (FePP)

Intervention Type DIETARY_SUPPLEMENT

Iron sulphate

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Prof. Michael B. Zimmermann

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael B Zimmermann, Prof

Role: PRINCIPAL_INVESTIGATOR

ETH Zürich

References

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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.

Reference Type DERIVED
PMID: 28468891 (View on PubMed)

Other Identifiers

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Fe-LNS

Identifier Type: -

Identifier Source: org_study_id

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