The effect of Milk Thistle extract versus tea on serum iron increase after a meal containing non-haem iron in Hereditary Haemochromatosis: a pilot study

INTERVENTION: The treatment intervention will consist of Legalon 140 mg (Madaus GmbH, Germany) milk thistle extract on one occasion with test meal. The comparator intervention will be a tea beverage on one occasion with test meal. The control will be the test meal with water. All patients will ingest the treatment (Milk Thistle capsule) with a meal, the comparator (tea) with an identical meal and control (the meal alone) on three separate occasions, four to seven days apart, and in a random order. The meal will contain 15.2 mg non‐radioactive non‐haem iron and will consist of vegetarian shepherd's pie, fruit salad and juice. On each occasion, blood will be drawn once before and once hourly for four hours after the meal, for measurement of total serum iron. CONDITION: Hereditary Haemochromatosis (HH) ; Nutritional, Metabolic, Endocrine ; Hereditary Haemochromatosis (HH) PRIMARY OUTCOME: Serum iron increase after the test meal on each of three occasions (meal with milk thistle, versus meal with tea, versus meal with water). SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: 1. Patients will be homozygous for the C282Y mutation of the HFE gene (the genotype associated with type one hereditary haemochromatosis), and have phenotypic haemochromatosis (identified by raised serum iron levels on diagnosis), as this is the particular group of interest which may benefit from interventions to reduce dietary iron absorption 2. ALL patients will be fully treated (i.e. undergoing phlebotomy to maintain iron stores within the normal range, following on from the removal of primary iron burden at diagnosis), in order to reduce variability in the data as iron absorption varies between fully treated and untreated/newly diagnosed patients 3. Patients will be adults (aged 18 or over), as type one hereditary haemochromatosis presents in adulthood