NCT03895424

Iron Isotope Study of an Iron Fatty Acid Complex

An Iron Isotope Study in Humans to Evaluate the Iron Bioavailability of a Novel Iron Compound - Iron Fatty Acid Complex

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Swiss Federal Institute of Technology · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The study aims at assessing the iron (Fe) bioavailability from a newly developed iron compound - an iron fatty acid complex. The iron from the compound is hypothesized to have a higher absorption rate than commonly available supplements in the market. The study is a cross over, human iron isotope study with three arms where participants consume the experimental dietary products in a randomized fashion. The study duration is of 45 days - from the day of the capsule administration till the last blood sampling point

Detailed description

Iron deficiency remains a major public health concern in both industrialized and non-industrialized (developing) countries. Most supplements in the present day, to address the problem of iron deficiency, are in the form of ferrous salts, especially ferrous sulfate. Ferrous salts are absorbed by the non-heme iron pathway involving the Divalent Metal Transporter 1 (DMT-1) receptor, where the absorption rate is 20% of the total iron content. The common strategy of the food supplement industries is to increase the iron load in the supplements to provide the necessary amount of iron, compensating for the low absorption rate. However, these have side effects associated with the high dosage. Instead of a high dosage, a more effective strategy would be to incorporate the iron in a way that the absorption rate is maximized. The intervention product, an iron fatty acid complex (IFAC), containing 12 mg of iron, is expected to be absorbed as effective as any ferrous sulfate supplement in the market due to the alternative metabolic route that is hypothesized to be taken by the complex. The first week of the study comprises of the administration of the capsules containing the complexes to the participants on day 1 , day 3 and day 5 of the study respectively. Blood samples are collected on day 10,20, 30 and 40 and 160 days after the last day of the capsule administration.. The primary objectives of this trial are: To assess the iron bioavailability from the developed iron salt fatty acid complexes (IFAC) and micro-emulsified iron fatty acid complex (MIFAC) and compare it with the bioavailability of the reference ferrous sulfate (FeSO4) To investigate whether the MIFAC promotes absorption compared to IFAC and the reference. Fractional iron absorption from the three intervention products will be calculated based on the shift of the stable iron isotope ratios in collected blood samples at 10, 20, 30, 40 and 160 days after administration of the stable isotopically labelled capsules. Stable iron isotope ratios will be determined by mass spectrometry.

Conditions

• Iron-deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	IFAC	This intervention will contain the iron fatty acid complex in a capsule. The complex will be labelled with the iron isotope 58Fe
DIETARY_SUPPLEMENT	MIFAC	This intervention will contain the micellarized form of the iron fatty acid complex in a capsule. The complex will be labelled with the iron isotope with 57Fe
DIETARY_SUPPLEMENT	Control Ferrous Sulfate	This intervention will contain ferrous sulfate in the form of a solution labelled with the iron isotope 54Fe. A capsule with the same amount of fat as in the other arms will be administered to the participants

Timeline

• Start date: 2019-01-07
• Primary completion: 2019-06-20
• Completion: 2019-06-20
• First posted: 2019-03-29
• Last updated: 2019-08-28

Locations

1 site across 1 country: Switzerland