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Iron Bioavailability From Cubes (Fe Bouillon)

Primary Purpose

Iron Deficiency

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Bouillon fortified with FePP

Bouillon fortified with FePP + Stabilizer

Bouillon fortified with FeSO4

Bouillon fortified with FeSO4 + Stabilizer

About this trial

This is an interventional prevention trial for Iron Deficiency focused on measuring Iron deficiency, Iron fortification

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

FePP

FePP + Stabilizer

FeSO4

FeSO4 + Stabilizer

Arm Description

Bouillon fortified with 4mg FePP

Bouillon fortified with 4mg FePP + Stabilizer

Bouillon fortified with 4mg FeSO4

Bouillon fortified with 4mg FeSO4 + Stabilizer

Outcomes

Primary Outcome Measures

Change from baseline in the isotopic ratio of iron in blood at week 2

The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

Change from week 4 in the isotopic ratio of iron in blood at week 6

The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

Secondary Outcome Measures

Full Information

NCT ID

NCT02327299

First Posted

December 23, 2014

Last Updated

December 23, 2014

Sponsor

Swiss Federal Institute of Technology

1. Study Identification

Unique Protocol Identification Number

NCT02327299

Brief Title

Iron Bioavailability From Cubes

Acronym

Fe Bouillon

Official Title

Assessment of the Bioavailability of Iron in Iron Fortified Bouillon Cubes in Healthy Women

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Swiss Federal Institute of Technology

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Iron Deficiency

Keywords

Iron deficiency, Iron fortification

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FePP

Arm Type

Experimental

Arm Description

Bouillon fortified with 4mg FePP

Arm Title

FePP + Stabilizer

Arm Type

Experimental

Arm Description

Bouillon fortified with 4mg FePP + Stabilizer

Arm Title

FeSO4

Arm Type

Experimental

Arm Description

Bouillon fortified with 4mg FeSO4

Arm Title

FeSO4 + Stabilizer

Arm Type

Experimental

Arm Description

Bouillon fortified with 4mg FeSO4 + Stabilizer

Intervention Type

Dietary Supplement

Intervention Name(s)

Bouillon fortified with FePP

Intervention Type

Dietary Supplement

Intervention Name(s)

Bouillon fortified with FePP + Stabilizer

Intervention Type

Dietary Supplement

Intervention Name(s)

Bouillon fortified with FeSO4

Intervention Type

Dietary Supplement

Intervention Name(s)

Bouillon fortified with FeSO4 + Stabilizer

Primary Outcome Measure Information:

Title

Change from baseline in the isotopic ratio of iron in blood at week 2

Description

The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

Time Frame

baseline, 2 weeks

Title

Change from week 4 in the isotopic ratio of iron in blood at week 6

Description

The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

Time Frame

4 weeks, 6 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

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Iron Bioavailability From Cubes

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