Iron Metabolism Disorders, Iron Overload, Polyphenols
Conditions
Brief summary
Polyphenolic compounds are very strong Inhibitors of non-heme iron absorption, as they form insoluble complexes with ferrous iron. Patients with hereditary hemochromatosis (HH) have an increased intestinal non-heme iron absorption due to a genetic mutation in the regulatory pathway, leading to excess iron in the body. This study investigates the inhibitory effect of a natural polyphenol Supplement in participants with HH.
Interventions
DIETARY_SUPPLEMENTmeal matrix & NPPS
Test meal consumed with the natural polyphenol supplement
DIETARY_SUPPLEMENTmeal matrix & CS
Test meal consumed with the control supplement
DIETARY_SUPPLEMENTno-matrix & NPPS
Test drink consumed with the natural polyphenol supplement
DIETARY_SUPPLEMENTno-matrix & CS
Test drink consumed with the control supplement
Sponsors
Instituto de Investigação em Imunologia
Swiss Federal Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Homozygous for C282Y mutation in HFE (hemochromatosis) gene * Written informed consent * Age 18-65 y * Not pregnant or lactating * Body weight \< 75 kg * Body mass index (BMI) between 18.5 and 25 kg/m2 * No acute illness/infection (self-reported) * No metabolic or gastrointestinal disorders, eating disorders or food allergy to the ingredients of the test meal (self-reported) * No scheduled phlebotomy throughout the study period * The last phlebotomy will be at least 4 weeks prior first test meal administration * No use of medications affecting iron absorption or metabolism during the study * No intake of mineral/vitamin supplements 2 weeks before the first study day and during the study * Participation in any other clinical study within the last 30 days * Expected to comply with study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline in the isotopic ratio of iron in blood at week 2 | baseline, 2 weeks | The change in the isotopic ratio of iron will be measured after administration of a test meal/drink including iron isotopes |
| change from baseline in the isotopic ratio of iron in blood at week 4 | 2 weeks, 4 weeks | The change in the isotopic ratio of iron will be measured after administration of a test meal/drink including iron isotopes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Soluble transferrin receptor (mg/L) | baseline, weeks 2, and 4 | to assess iron status |
| Transferrin saturation in % | baseline, weeks 2, and 4 | to calculate percent of transferrin that has iron bound to it; Plasma iron and transferrin saturation will be combined to calculate transferrin saturation (ratio) |
| Hemoglobin (g/dL) | baseline, weeks 2, and 4 | to assess blood volume based on weight, height, and Hb. |
| Serum Ferritin concentration (µg/L) | baseline, weeks 2, and 4 | to assess iron status |
| alpha-1-glycoprotein (g/L) | baseline, weeks 2, and 4 | identify chronic inflammation |
| Serum Hepcidin (nM) | baseline, and weeks 2 | the major regulator of non-heme iron absorption |
| C-reactive Protein (mg/L) | baseline, weeks 2, and 4 | identify acute inflammation |
| Serum iron concentration (µg/dL) | baseline, weeks 2, and 4 | to assess iron status |
Countries
Portugal, Switzerland
Outcome results
None listed