Clinical trial NCT03895424: Iron Isotope Study of an Iron Fatty Acid Complex
Official title: An Iron Isotope Study in Humans to Evaluate the Iron Bioavailability of a Novel Iron Compound - Iron Fatty Acid Complex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency
Keywords: Iron
Isotope study
Fatty Acid
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Mibelle AG
First posted: 2019-03-29
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* age of 18 - 40 years old
* marginal iron status (ferritin \<25 ng/ml; measured by study coordinator)
* body weight up to 65 kg
* normal body mass index (bodyweight \[kg\] / (height \[m\])2 = 18.5 - 25)
* do not take any vitamin or mineral supplements two weeks before and during the study.
* do not have a metabolic, gastrointestinal or chronic diseases
* able to communicate in and comprehend English language

Exclusion Criteria:

* pregnant or breast-feeding
* on long-term medication (except oral contraceptive)
* elevated C-reactive Protein (\>5mg/L; will be measured by study coordinator)
* medium or strong anemic (hemoglobin \<9.0 g/dL; will be measured by study coordinator)
* donated blood within the last 4 months before the study start date
* taking part in another clinical study at the same time or had within the last 30 days before the study date
* participated in an earlier study using iron stable isotopes.
* eating disorder or a strong allergy.
* cannot be expected to comply with study protocol (e.g. not available on certain study appointments or difficulties with blood sampling)
* unable to understand the information sheet and the informed consent form due to cognitive or language reasons

Primary outcomes:
measure: Fractional iron absorption from IFAC
timeFrame: Day 10 of the study
measure: Fractional iron absorption from IFAC
timeFrame: Day 20 of the study
measure: Fractional iron absorption from IFAC
timeFrame: Day 30 of the study
measure: Fractional iron absorption from IFAC
timeFrame: Day 40 of the study
measure: Fractional iron absorption from IFAC
timeFrame: Day 160 of the study
measure: Fractional iron absorption from MIFAC
timeFrame: Day 10 of the study
measure: Fractional iron absorption from MIFAC
timeFrame: Day 20 of the study
measure: Fractional iron absorption from MIFAC
timeFrame: Day 30 of the study
measure: Fractional iron absorption from MIFAC
timeFrame: Day 40 of the study
measure: Fractional iron absorption from MIFAC
timeFrame: Day 160 of the study
measure: Fractional iron absorption from Control Ferrous Sulfate
timeFrame: Day 10 of the study
measure: Fractional iron absorption from Control Ferrous Sulfate
timeFrame: Day 20 of the study
measure: Fractional iron absorption from Control Ferrous Sulfate
timeFrame: Day 30 of the study
measure: Fractional iron absorption from Control Ferrous Sulfate
timeFrame: Day 40 of the study
measure: Fractional iron absorption from Control Ferrous Sulfate
timeFrame: Day 160 of the study
Secondary outcomes:
measure: Haemoglobin
timeFrame: Day 1 of the study
measure: Haemoglobin
timeFrame: Day 10 of the study
measure: Haemoglobin
timeFrame: Day 20 of the study
measure: Haemoglobin
timeFrame: Day 30 of the study
measure: Haemoglobin
timeFrame: Day 40 of the study
measure: Haemoglobin
timeFrame: Day 160 of the study
measure: Ferritin
timeFrame: Day 1 of the study
measure: Ferritin
timeFrame: Day 10 of the study
measure: Ferritin
timeFrame: Day 20 of the study
measure: Ferritin
timeFrame: Day 30 of the study
measure: Ferritin
timeFrame: Day 40 of the study
measure: C-reactive Protein
timeFrame: Day 1 of the study
measure: C-reactive Protein
timeFrame: Day 10 of the study
measure: C-reactive Protein
timeFrame: Day 20 of the study
measure: C-reactive Protein
timeFrame: Day 30 of the study
measure: C-reactive Protein
timeFrame: Day 40 of the study
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Lab of Human Nutrition, ETH Zurich
state: ZH
Study officials:
affiliation: Swiss Federal Institute of Technology
name: Michael Zimmermann, PhD
role: PRINCIPAL_INVESTIGATOR
References: