Iron Bioavailability From Cubes (Fe Bouillon)

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

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.

Study Overview

• Status: Completed
• Conditions: Iron Deficiency
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, 2 weeks
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.	4 weeks, 6 weeks

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 23, 2014
• First Submitted That Met QC Criteria: December 23, 2014
• First Posted (Estimate): December 30, 2014

Study Record Updates

• Last Update Posted (Estimate): December 30, 2014
• Last Update Submitted That Met QC Criteria: December 23, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Iron deficiency; Iron fortification
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Fesoterodine
• Other Study ID Numbers: FDS-SAV-1615