Healthy Volunteers
Conditions
Brief summary
Determination of fractional iron absorption from dairy product fortified with 2 labelled iron compounds
Detailed description
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
Interventions
DIETARY_SUPPLEMENTDairy product fortified with enriched Fe-54 salt (1)
2.5mg of Fe per 100g of product
DIETARY_SUPPLEMENTDairy product fortified with enriched Fe-57 salt (2)
2.5mg of Fe per 100g of product
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Women aged 18-40 years old, * Healthy, based on the medical screening visit including a blood formula and biochemistry, * Normal BMI for age (18.5-25.0), * Weight less than 65 kg, * Having obtained informed consent prior trial entry.
Exclusion criteria
* Anemia or polycythemia respectively evidenced, * Significant blood losses over the past 6 months, * Plasma ferritin out of 8-50 ug/L range. * Any infectious and inflammatory disease in the past four weeks, * Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease, * Known food allergy, * Pregnancy (anamnesis) and/or lactation, * History of cancer within the past year, * Significant weight loss during the last 3 months (5% and more), * medication or supplement which may impact red cells count, Hb or Ht * Fe supplementation or perfusion in the last three months, * Smokers (\>5 cigarettes), * Have a high alcohol consumption (more than 2 drinks/day), * Consumption of illicit drugs anamnesis only, * Subject having a hierarchical link with the Investigator or co-investigators, * Subject who cannot be expected to comply with treatment or study procedure, * participating or having participated in another clinical trial during the past month prior to the beginning of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the isotopic ratio of iron in blood at week 2 | 14 days after the last stable isotope administration | 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 |
|---|---|---|
| Measurement of plasma ferritin as biomarker of Fe status | On the 1st day of the stable isotope administration | The plasma ferritin will be measured before the administration of test meal including iron isotopes |
Countries
Switzerland
Outcome results
None listed