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

NCT ID: NCT03990181

Last Updated: 2021-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-20

Study Completion Date

2020-08-15

Brief Summary

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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.

Detailed Description

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Conditions

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Iron Metabolism Disorders Iron Overload Polyphenols

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Meal & natural polyphenol supplement (NPPS)

A meal, labelled with stable iron isotope as ferrous sulphate, consumed with the natural polyphenol supplement

Group Type EXPERIMENTAL

meal matrix & NPPS

Intervention Type DIETARY_SUPPLEMENT

Test meal consumed with the natural polyphenol supplement

Drink & natural polyphenol supplement

A drink, labelled with stable iron isotope as ferrous sulphate, consumed with the natural polyphenol supplement

Group Type EXPERIMENTAL

no-matrix & NPPS

Intervention Type DIETARY_SUPPLEMENT

Test drink consumed with the natural polyphenol supplement

Meal & control supplement (CS)

A meal, labelled with stable iron isotope as ferrous sulphate, consumed with a control supplement

Group Type PLACEBO_COMPARATOR

meal matrix & CS

Intervention Type DIETARY_SUPPLEMENT

Test meal consumed with the control supplement

Drink & control supplement

A drink, labelled with stable iron isotope as ferrous sulphate, consumed with a control supplement

Group Type PLACEBO_COMPARATOR

no-matrix & CS

Intervention Type DIETARY_SUPPLEMENT

Test drink consumed with the control supplement

Interventions

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meal matrix & NPPS

Test meal consumed with the natural polyphenol supplement

Intervention Type DIETARY_SUPPLEMENT

meal matrix & CS

Test meal consumed with the control supplement

Intervention Type DIETARY_SUPPLEMENT

no-matrix & NPPS

Test drink consumed with the natural polyphenol supplement

Intervention Type DIETARY_SUPPLEMENT

no-matrix & CS

Test drink consumed with the control supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto de Investigação em Imunologia

OTHER

Sponsor Role collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Prof. Michael B. Zimmermann

Head of the Laboratory of Human Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Porto University Hospital Center

Porto, , Portugal

Site Status

Laboratory of Human Nutrition ETH Zurich

Zurich, , Switzerland

Site Status

Countries

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Portugal Switzerland

References

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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.

Reference Type DERIVED
PMID: 35320401 (View on PubMed)

Other Identifiers

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FePPHH

Identifier Type: -

Identifier Source: org_study_id

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