Iron-deficiency
Conditions
Keywords
Iron deficiency, Iron fortification, Iron encapsulation
Brief summary
Food fortification has shown to be efficacious to alleviate the burden of micronutrient deficiencies. Ensuring the bioavailability of iron and maintaining the sensory quality and stability of the fortified food and other added micronutrients remains a challenge. Soluble iron compounds cause minor organoleptic changes in foods but their bioavailability in man is rather low. Water-soluble iron compounds, such as ferrous sulphate (FeSO4), are the compounds in which the iron is most bioavailable; however, they often cause unfavorable sensory changes. Encapsulation of iron has excellent potential for overcoming unwanted sensory changes and iodine losses in salt, while maintaining acceptable bioavailability. In the present project, we would like to investigate the iron bioavailability from a new formulation of encapsulated iron sulphate based on hyaluronic acid (HA) and a polymer from the eudragit family.
Interventions
DIETARY_SUPPLEMENTfree FeSO4
Testmeal with free FeSO4
DIETARY_SUPPLEMENTfree FeSO4 and empty microspheres
Testmeal with free FeSO4 and empty micropsheres
DIETARY_SUPPLEMENTfree FeSO4 and hylauronic acid
Testmeal with free FeSO4 and hyaluronic acid
DIETARY_SUPPLEMENTfree FeSO4 and eudragit polymer
Testmeal with free FeSO4 and eudragit polymer
DIETARY_SUPPLEMENTencapsulated FeSO4 3.2%
Testmeal with encapsulated FeSO4 with 3.2% Fe loading
DIETARY_SUPPLEMENTencapsulated FeSO4 20%
Testmeal with encapsulated FeSO4 with 20% Fe loading
DIETARY_SUPPLEMENTencapsulated FeSO4 3.2%, encapsulated Vitamin A
Testmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A
DIETARY_SUPPLEMENTencapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic Acid
Testmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A, with free folic acid.
DIETARY_SUPPLEMENTFeSO4 embedded in Hyaluronic acid
Testmeal with FeSO4 embedded in Hyaluronic acid
Sponsors
Swiss Federal Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Female, 18 to 40 years old * Marginal iron status (PF \<25 ng/ml) * Body weight \< 65 kg * Normal body Mass Index (18.5 - 25 kg/m2) * Signed informed consent
Exclusion criteria
* Pregnancy (assessed by a pregnancy test) / intention to become pregnant * Lactating up to 6 weeks before study initiation * Moderate or severe anaemia (Hb \< 9.0 g/dL) * Elevated C reactive Protein (CRP) (\> 5.0 mg/L) * Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement) * Continuous/long-term use of medication during the whole study (except for contraceptives) * Consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration * Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months * Earlier participation in a study using Fe stable isotopes or participation in any clinical study within the last 30 days * Participant who cannot be expected to comply with study protocol (e.g. not available on certain study appointments or difficulties with blood sampling)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 2 in the isotopic ratio of iron in blood at week 4 | 2 weeks, 4 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Haemoglobin | baseline, weeks 2, 4 and 6 | Haemoglobin of each timepoint |
| Plasma Ferritin | baseline, weeks 2, 4 and 6 | Plasma Ferritin of each timepoint |
| inflammation marker | baseline, weeks 2, 4 and 6 | C reactive Protein of each timepoint |
Countries
Switzerland
Outcome results
None listed