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.
Name: meal matrix & NPPS
Name: meal matrix & CS
Name: no-matrix & NPPS
Name: no-matrix & CS
Description: The change in the isotopic ratio of iron will be measured after administration of a test meal/drink including iron isotopes
Measure: change from baseline in the isotopic ratio of iron in blood at week 2 Time: baseline, 2 weeksDescription: The change in the isotopic ratio of iron will be measured after administration of a test meal/drink including iron isotopes
Measure: change from baseline in the isotopic ratio of iron in blood at week 4 Time: 2 weeks, 4 weeksDescription: to assess iron status
Measure: Serum Ferritin concentration (µg/L) Time: baseline, weeks 2, and 4Description: to assess iron status
Measure: Serum iron concentration (µg/dL) Time: baseline, weeks 2, and 4Description: to assess iron status
Measure: Soluble transferrin receptor (mg/L) Time: baseline, weeks 2, and 4Description: to calculate percent of transferrin that has iron bound to it; Plasma iron and transferrin saturation will be combined to calculate transferrin saturation (ratio)
Measure: Transferrin saturation in % Time: baseline, weeks 2, and 4Description: to assess blood volume based on weight, height, and Hb.
Measure: Hemoglobin (g/dL) Time: baseline, weeks 2, and 4Description: identify acute inflammation
Measure: C-reactive Protein (mg/L) Time: baseline, weeks 2, and 4Description: identify chronic inflammation
Measure: alpha-1-glycoprotein (g/L) Time: baseline, weeks 2, and 4Description: the major regulator of non-heme iron absorption
Measure: Serum Hepcidin (nM) Time: baseline, and weeks 2Allocation: Randomized
Crossover Assignment
There is one SNP
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 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 Iron Metabolism Disorders Iron Overload Polyphenols Hemochromatosis Iron Overload Metabolic Diseases Iron Metabolism Disorders null --- C282Y ---
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 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 Iron Metabolism Disorders Iron Overload Polyphenols Hemochromatosis Iron Overload Metabolic Diseases Iron Metabolism Disorders null --- C282Y --- --- C282Y ---