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

Primary Purpose

Iron Metabolism Disorders, Iron Overload, Polyphenols

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
meal matrix & NPPS
meal matrix & CS
no-matrix & NPPS
no-matrix & CS
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Iron Metabolism Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Porto University Hospital Center
  • Laboratory of Human Nutrition ETH Zurich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Meal & natural polyphenol supplement (NPPS)

Drink & natural polyphenol supplement

Meal & control supplement (CS)

Drink & control supplement

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

change from baseline in the isotopic ratio of iron in blood at week 2
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
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)
to assess iron status
Serum iron concentration (µg/dL)
to assess iron status
Soluble transferrin receptor (mg/L)
to assess iron status
Transferrin saturation in %
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)
to assess blood volume based on weight, height, and Hb.
C-reactive Protein (mg/L)
identify acute inflammation
alpha-1-glycoprotein (g/L)
identify chronic inflammation
Serum Hepcidin (nM)
the major regulator of non-heme iron absorption

Full Information

First Posted
June 9, 2019
Last Updated
May 23, 2021
Sponsor
Swiss Federal Institute of Technology
Collaborators
Instituto de Investigação em Imunologia
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1. Study Identification

Unique Protocol Identification Number
NCT03990181
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 20, 2019 (Actual)
Primary Completion Date
August 15, 2020 (Actual)
Study Completion Date
August 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Swiss Federal Institute of Technology
Collaborators
Instituto de Investigação em Imunologia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Metabolism Disorders, Iron Overload, Polyphenols

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meal & natural polyphenol supplement (NPPS)
Arm Type
Experimental
Arm Description
A meal, labelled with stable iron isotope as ferrous sulphate, consumed with the natural polyphenol supplement
Arm Title
Drink & natural polyphenol supplement
Arm Type
Experimental
Arm Description
A drink, labelled with stable iron isotope as ferrous sulphate, consumed with the natural polyphenol supplement
Arm Title
Meal & control supplement (CS)
Arm Type
Placebo Comparator
Arm Description
A meal, labelled with stable iron isotope as ferrous sulphate, consumed with a control supplement
Arm Title
Drink & control supplement
Arm Type
Placebo Comparator
Arm Description
A drink, labelled with stable iron isotope as ferrous sulphate, consumed with a control supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
meal matrix & NPPS
Intervention Description
Test meal consumed with the natural polyphenol supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
meal matrix & CS
Intervention Description
Test meal consumed with the control supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
no-matrix & NPPS
Intervention Description
Test drink consumed with the natural polyphenol supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
no-matrix & CS
Intervention Description
Test drink consumed with the control supplement
Primary Outcome Measure Information:
Title
change from baseline in the isotopic ratio of iron in blood at week 2
Description
The change in the isotopic ratio of iron will be measured after administration of a test meal/drink including iron isotopes
Time Frame
baseline, 2 weeks
Title
change from baseline in the isotopic ratio of iron in blood at week 4
Description
The change in the isotopic ratio of iron will be measured after administration of a test meal/drink including iron isotopes
Time Frame
2 weeks, 4 weeks
Secondary Outcome Measure Information:
Title
Serum Ferritin concentration (µg/L)
Description
to assess iron status
Time Frame
baseline, weeks 2, and 4
Title
Serum iron concentration (µg/dL)
Description
to assess iron status
Time Frame
baseline, weeks 2, and 4
Title
Soluble transferrin receptor (mg/L)
Description
to assess iron status
Time Frame
baseline, weeks 2, and 4
Title
Transferrin saturation in %
Description
to calculate percent of transferrin that has iron bound to it; Plasma iron and transferrin saturation will be combined to calculate transferrin saturation (ratio)
Time Frame
baseline, weeks 2, and 4
Title
Hemoglobin (g/dL)
Description
to assess blood volume based on weight, height, and Hb.
Time Frame
baseline, weeks 2, and 4
Title
C-reactive Protein (mg/L)
Description
identify acute inflammation
Time Frame
baseline, weeks 2, and 4
Title
alpha-1-glycoprotein (g/L)
Description
identify chronic inflammation
Time Frame
baseline, weeks 2, and 4
Title
Serum Hepcidin (nM)
Description
the major regulator of non-heme iron absorption
Time Frame
baseline, and weeks 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Porto University Hospital Center
City
Porto
Country
Portugal
Facility Name
Laboratory of Human Nutrition ETH Zurich
City
Zurich
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35320401
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.
Results Reference
derived

Learn more about this trial

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

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