Clinical trial NCT03990181: Inhibiting Dietary Iron Absorption in Subjects With Hereditary Hemochromatosis by a Natural Polyphenol Supplement
Official title: Testing the Efficacy of a Natural Polyphenol Supplement to Inhibit Dietary Iron Absorption in Subjects With Hereditary Hemochromatosis: a Stable Isotope Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Metabolism Disorders
Iron Overload
Polyphenols
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Instituto de Investigação em Imunologia
First posted: 2019-06-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: change from baseline in the isotopic ratio of iron in blood at week 2
timeFrame: baseline, 2 weeks
measure: change from baseline in the isotopic ratio of iron in blood at week 4
timeFrame: 2 weeks, 4 weeks
Secondary outcomes:
measure: Serum Ferritin concentration (µg/L)
timeFrame: baseline, weeks 2, and 4
measure: Serum iron concentration (µg/dL)
timeFrame: baseline, weeks 2, and 4
measure: Soluble transferrin receptor (mg/L)
timeFrame: baseline, weeks 2, and 4
measure: Transferrin saturation in %
timeFrame: baseline, weeks 2, and 4
measure: Hemoglobin (g/dL)
timeFrame: baseline, weeks 2, and 4
measure: C-reactive Protein (mg/L)
timeFrame: baseline, weeks 2, and 4
measure: alpha-1-glycoprotein (g/L)
timeFrame: baseline, weeks 2, and 4
measure: Serum Hepcidin (nM)
timeFrame: baseline, and weeks 2
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Porto University Hospital Center
city: Zurich
country: Switzerland
facility: Laboratory of Human Nutrition ETH Zurich
Study officials:
References:
citation: Buerkli S, Salvioni L, Koller N, Zeder C, Teles MJ, Porto G, Habermann JH, Dubach IL, Vallelian F, Frey BM, Moretti D, Baumgartner J, Zimmermann MB. The effect of a natural polyphenol supplement on iron absorption in adults with hereditary hemochromatosis. Eur J Nutr. 2022 Sep;61(6):2967-2977. doi: 10.1007/s00394-022-02829-8. Epub 2022 Mar 23.