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Determination of fractional iron absorption from dairy product fortified with 2 labelled iron compounds
This single center trial will be double-blind, controlled randomized with a crossover trial. One group (n=10) will start the study with the consumption of a Fe-54 salt fortified dairy product, while the other group will start the study with the consumption of Fe-57 salt fortified dairy product. The day after, in a cross over design, subjects will be administered the alternative test product. A blood sampling will be performed 14 days after the last stable isotope administration to allow the measurement of Fe stable isotope ratios and the calculation of Fe absorption. The duration of the trial will be 16 days in total.
The total sample size is 20 enrolled subjects. Patients will be healthy females aged 18-40 years old
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dairy product + Salt 1 | Active Comparator | Dairy product fortified with enriched Fe-54 salt (1) |
|
| Dairy product + Salt 2 | Experimental | Dairy product fortified with enriched Fe-57 salt (2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dairy product fortified with enriched Fe-54 salt (1) | Dietary Supplement | 2.5mg of Fe per 100g of product |
|
| 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 | 14 days after the last stable isotope administration |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of plasma ferritin as biomarker of Fe status | The plasma ferritin will be measured before the administration of test meal including iron isotopes | On the 1st day of the stable isotope administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maurice Beaumont | Metabolic Unit - Nestec | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metabolic Unit, Clinical Development Unit, Nestec | Lausanne | 1000 | Switzerland |
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| Dairy product fortified with enriched Fe-57 salt (2) | Dietary Supplement | 2.5mg of Fe per 100g of product |
|