CompletedNot Applicable

Inhibiting Dietary Iron Absorption in Subjects With Hereditary Hemochromatosis by a Natural Polyphenol Supplement

Portugal, Switzerland14 participantsStarted 2019-09-20

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

change from baseline in the isotopic ratio of iron in blood at week 2

Timeframe: baseline, 2 weeks

change from baseline in the isotopic ratio of iron in blood at week 4

Timeframe: 2 weeks, 4 weeks

Trial details

NCT IDNCT03990181

SponsorSwiss Federal Institute of Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-08-15