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Iron Bioavailability From Cubes

NCT ID: NCT02327299

Last Updated: 2014-12-30

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2014-12-31

Brief Summary

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Iron deficiency is a highly prevalent nutrient deficiency which is a public health problem, especially in developing countries. There are several strategies to correct iron deficiency in populations: besides supplementation with tablets, one of the most sustainable and effective strategies on medium term has been iron fortification, the addition of iron to regularly consumed foods. In fortification, the chemical nature of the compound to be added plays an important role: depending on the compound sensory qualities of the fortified foods can vary as well as the iron absorption. Iron pyrophosphate (FePP) and ferrous sulfate (FeSO4) are two commonly used iron fortification compounds in foods such as rice, breakfast cereals, pasta, flour and others. We want to test the effect of addition a food stabilizer on the absorption of ferric pyrophosphate (FePP) and ferrous sulfate (FeSO4) when added to bouillon, as was recently suggested by in vitro experiments in the laboratory.

Detailed Description

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Conditions

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Iron Deficiency

Keywords

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Iron deficiency Iron fortification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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FePP

Bouillon fortified with 4mg FePP

Group Type EXPERIMENTAL

Bouillon fortified with FePP

Intervention Type DIETARY_SUPPLEMENT

FePP + Stabilizer

Bouillon fortified with 4mg FePP + Stabilizer

Group Type EXPERIMENTAL

Bouillon fortified with FePP + Stabilizer

Intervention Type DIETARY_SUPPLEMENT

FeSO4

Bouillon fortified with 4mg FeSO4

Group Type EXPERIMENTAL

Bouillon fortified with FeSO4

Intervention Type DIETARY_SUPPLEMENT

FeSO4 + Stabilizer

Bouillon fortified with 4mg FeSO4 + Stabilizer

Group Type EXPERIMENTAL

Bouillon fortified with FeSO4 + Stabilizer

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Bouillon fortified with FePP

Intervention Type DIETARY_SUPPLEMENT

Bouillon fortified with FePP + Stabilizer

Intervention Type DIETARY_SUPPLEMENT

Bouillon fortified with FeSO4

Intervention Type DIETARY_SUPPLEMENT

Bouillon fortified with FeSO4 + Stabilizer

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 and \< 40 years at screening;
* Body weight \<65 kg;
* Apparently healthy: no medical conditions which might affect study measurements (judged by study physician);
* With low iron stores (serum ferritin \<15µg/L);
* Reported intense sporting activities ≤10h/w;
* Reported alcohol consumption ≤14 units/w;
* Currently not smoking and being a non-smoker for at least six months and no reported use of any nicotine containing products in the six months preceding the study and during the study itself;
* Willing and able to participate in the study;
* Having given a written informed consent.

Exclusion Criteria

* Being an employee of Unilever or the Laboratory of Human Nutrition of the ETH Zürich;
* Blood donation or significant blood loss over the past 6 months;
* Reported use of any medically- or self-prescribed diet;
* Use of medication (except oral contraceptives)
* Use of vitamin or mineral supplements and unwillingness to discontinue their use two weeks prior the study and during the study;
* Smoking or consuming tobacco in any form, and/or was smoking or consuming tobacco in any form for 6 months preceding the study and/or will be smoking or consuming tobacco in any form, during the study;
* Is pregnant or will be planning pregnancy during the study period;
* Is lactating or has been lactating in the 6 weeks before pre-study investigation and/or during the study period;
* Known gastrointestinal or metabolic disorders;
* Moderate or severe anemia defined as Hb \< 90 g/L.
* Participation in another clinical trial during the last 30 days prior to the beginning of the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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FDS-SAV-1615

Identifier Type: -

Identifier Source: org_study_id