Iron Bioavailability From Dairy Product

Nestlé

Status

Completed

Conditions

Healthy Volunteers

Treatments

Dietary Supplement: Dairy product fortified with enriched Fe-54 salt (1)

Dietary Supplement: Dairy product fortified with enriched Fe-57 salt (2)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02585661

15.06.MET

Details and patient eligibility

About

Determination of fractional iron absorption from dairy product fortified with 2 labelled iron compounds

Full 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

Enrollment

20 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.