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 range

18 Years – 65 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Iron Metabolism Disorders trials