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

Sponsor

Swiss Federal Institute of Technology (Other)

Overall Status

Completed

CT.gov ID

NCT03990181

Collaborator

Instituto de Investigação em Imunologia (Other)

Enrollment

Locations

Arms

10.8

Actual Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Iron Metabolism Disorders Iron Overload Polyphenols	Dietary Supplement: meal matrix & NPPS Dietary Supplement: meal matrix & CS Dietary Supplement: no-matrix & NPPS Dietary Supplement: no-matrix & CS	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

Testing the Efficacy of a Natural Polyphenol Supplement to Inhibit Dietary Iron Absorption in Subjects With Hereditary Hemochromatosis: a Stable Isotope Study

Actual Study Start Date :

Sep 20, 2019

Actual Primary Completion Date :

Aug 15, 2020

Actual Study Completion Date :

Aug 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Meal & natural polyphenol supplement (NPPS) A meal, labelled with stable iron isotope as ferrous sulphate, consumed with the natural polyphenol supplement	Dietary Supplement: meal matrix & NPPS Test meal consumed with the natural polyphenol supplement
Experimental: Drink & natural polyphenol supplement A drink, labelled with stable iron isotope as ferrous sulphate, consumed with the natural polyphenol supplement	Dietary Supplement: no-matrix & NPPS Test drink consumed with the natural polyphenol supplement
Placebo Comparator: Meal & control supplement (CS) A meal, labelled with stable iron isotope as ferrous sulphate, consumed with a control supplement	Dietary Supplement: meal matrix & CS Test meal consumed with the control supplement
Placebo Comparator: Drink & control supplement A drink, labelled with stable iron isotope as ferrous sulphate, consumed with a control supplement	Dietary Supplement: no-matrix & CS Test drink consumed with the control supplement

Outcome Measures

Primary Outcome Measures

change from baseline in the isotopic ratio of iron in blood at week 2 [baseline, 2 weeks]
The change in the isotopic ratio of iron will be measured after administration of a test meal/drink including iron isotopes
change from baseline in the isotopic ratio of iron in blood at week 4 [2 weeks, 4 weeks]
The change in the isotopic ratio of iron will be measured after administration of a test meal/drink including iron isotopes

Secondary Outcome Measures

Serum Ferritin concentration (µg/L) [baseline, weeks 2, and 4]
to assess iron status
Serum iron concentration (µg/dL) [baseline, weeks 2, and 4]
to assess iron status
Soluble transferrin receptor (mg/L) [baseline, weeks 2, and 4]
to assess iron status
Transferrin saturation in % [baseline, weeks 2, and 4]
to calculate percent of transferrin that has iron bound to it; Plasma iron and transferrin saturation will be combined to calculate transferrin saturation (ratio)
Hemoglobin (g/dL) [baseline, weeks 2, and 4]
to assess blood volume based on weight, height, and Hb.
C-reactive Protein (mg/L) [baseline, weeks 2, and 4]
identify acute inflammation
alpha-1-glycoprotein (g/L) [baseline, weeks 2, and 4]
identify chronic inflammation
Serum Hepcidin (nM) [baseline, and weeks 2]
the major regulator of non-heme iron absorption

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Porto University Hospital Center	Porto		Portugal
2	Laboratory of Human Nutrition ETH Zurich	Zurich		Switzerland

Sponsors and Collaborators

Swiss Federal Institute of Technology
Instituto de Investigação em Imunologia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Michael B. Zimmermann, Head of the Laboratory of Human Nutrition, Swiss Federal Institute of Technology

ClinicalTrials.gov Identifier:

NCT03990181

Other Study ID Numbers:

FePPHH

First Posted:

Jun 18, 2019

Last Update Posted:

May 26, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Iron Metabolism Disorders

Study Results

No Results Posted as of May 26, 2021