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. In this Study we investigate the inhibitory effect of a natural polyphenol Supplement in subjects with HH.
Name: meal matrix & NPPS
Description: Test meal consumed with the natural polyphenol supplementType: Dietary SupplementMeal Meal & Meal & natural polyphenol supplement (NPPS)
Name: meal matrix & CS
Description: Test meal consumed with the control supplementType: Dietary SupplementMeal Meal & Meal & control supplement (CS)
Name: no-matrix & NPPS
Description: Test drink consumed with the natural polyphenol supplementType: Dietary SupplementDrink Drink & Drink & natural polyphenol supplement
Name: no-matrix & CS
Description: Test drink consumed with the control supplementType: Dietary SupplementDrink Drink & Drink & control supplement
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: commonly measured iron status markers (Serum iron, transferrin saturation, Serum Ferritin, hemoglobin, and erythrocyte volume)
Measure: Iron status markers Time: baseline, weeks 2, and 4Description: fasting Serum hepcidin concentrations
Measure: Hepcidin 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 Iron Overload Metabolic Diseases Hemochromatosis 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 Iron Overload Metabolic Diseases Hemochromatosis Iron Metabolism Disorders null --- C282Y --- --- C282Y ---