Fe Bouillon: Iron Bioavailability From Cubes

Sponsor

Swiss Federal Institute of Technology (Other)

Overall Status

Completed

CT.gov ID

NCT02327299

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiency	Dietary Supplement: Bouillon fortified with FePP Dietary Supplement: Bouillon fortified with FePP + Stabilizer Dietary Supplement: Bouillon fortified with FeSO4 Dietary Supplement: Bouillon fortified with FeSO4 + Stabilizer	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FePP Bouillon fortified with 4mg FePP	Dietary Supplement: Bouillon fortified with FePP
Experimental: FePP + Stabilizer Bouillon fortified with 4mg FePP + Stabilizer	Dietary Supplement: Bouillon fortified with FePP + Stabilizer
Experimental: FeSO4 Bouillon fortified with 4mg FeSO4	Dietary Supplement: Bouillon fortified with FeSO4
Experimental: FeSO4 + Stabilizer Bouillon fortified with 4mg FeSO4 + Stabilizer	Dietary Supplement: Bouillon fortified with FeSO4 + Stabilizer

Outcome Measures

Primary Outcome Measures

Change from baseline in the isotopic ratio of iron in blood at week 2 [baseline, 2 weeks]
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 [4 weeks, 6 weeks]
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Swiss Federal Institute of Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Swiss Federal Institute of Technology

ClinicalTrials.gov Identifier:

NCT02327299

Other Study ID Numbers:

FDS-SAV-1615

First Posted:

Dec 30, 2014

Last Update Posted:

Dec 30, 2014

Last Verified:

Dec 1, 2014

Keywords provided by Swiss Federal Institute of Technology

Iron deficiency

Iron fortification

Additional relevant MeSH terms:

Anemia, Iron-Deficiency

Fesoterodine

Study Results

No Results Posted as of Dec 30, 2014