Bioavailability of Iron From Savoury Food Product

Study Overview
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Brief Summary
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The study is designed to assess the bioavailability of iron from 4 different iron fortified savoury food products

Official Title
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Assessment of the Bioavailability of Iron in Iron Fortified Savoury Food Product in Healthy Women

Conditions
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Healthy, Iron Deficiency

Intervention / Treatment
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* Other: Savoury food product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female subjects; 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 iron deficiency (Serum ferritin <15µg/L); 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: 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; 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; Participation in another clinical trial during the last 30 days prior to the beginning of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fortified savoury food product 1<br>Savoury food product fortified with iron | Other: Savoury food product<br> <br> |
| Experimental: Fortified savoury food product 2<br>Savoury food product fortified with iron | Other: Savoury food product<br> <br> |
| Experimental: Fortified savoury food product 3<br>Savoury food product fortified with iron | Other: Savoury food product<br> <br> |
| Experimental: Fortified savoury food product 4<br>Savoury food product fortified with iron | Other: Savoury food product<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the absolute bioavailability of iron from 4 different iron fortified savoury food products | Amounts of Fe isotopic label present in the blood 14 days after administration of the fortified savoury food product will be calculated based on measured shifts in the iron isotope ratios in the blood samples (Day 15) compared to baseline and the amount of iron circulating in the body | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the relative bioavailability of iron from iron fortified savoury food products | The absolute bioavailability results of each of the iron fortified savoury products as obtained under the primary objective will be compared with each other | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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female, subjects