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出境医 / 临床实验 / Inhibiting Dietary Iron Absorption in Subjects With Hereditary Hemochromatosis by a Natural Polyphenol Supplement

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

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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : September 20, 2019
Actual Primary Completion Date : August 15, 2020
Actual Study Completion Date : August 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 :
  1. change from baseline in the isotopic ratio of iron in blood at week 2 [ Time Frame: baseline, 2 weeks ]
    The change in the isotopic ratio of iron will be measured after administration of a test meal/drink including iron isotopes

  2. change from baseline in the isotopic ratio of iron in blood at week 4 [ Time Frame: 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 :
  1. Serum Ferritin concentration (µg/L) [ Time Frame: baseline, weeks 2, and 4 ]
    to assess iron status

  2. Serum iron concentration (µg/dL) [ Time Frame: baseline, weeks 2, and 4 ]
    to assess iron status

  3. Soluble transferrin receptor (mg/L) [ Time Frame: baseline, weeks 2, and 4 ]
    to assess iron status

  4. Transferrin saturation in % [ Time Frame: 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)

  5. Hemoglobin (g/dL) [ Time Frame: baseline, weeks 2, and 4 ]
    to assess blood volume based on weight, height, and Hb.

  6. C-reactive Protein (mg/L) [ Time Frame: baseline, weeks 2, and 4 ]
    identify acute inflammation

  7. alpha-1-glycoprotein (g/L) [ Time Frame: baseline, weeks 2, and 4 ]
    identify chronic inflammation

  8. Serum Hepcidin (nM) [ Time Frame: baseline, and weeks 2 ]
    the major regulator of non-heme iron absorption


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Locations
Layout table for location information
Portugal
Porto University Hospital Center
Porto, Portugal
Switzerland
Laboratory of Human Nutrition ETH Zurich
Zurich, Switzerland
Sponsors and Collaborators
Swiss Federal Institute of Technology
Instituto de Investigação em Imunologia
Tracking Information
First Submitted Date  ICMJE June 9, 2019
First Posted Date  ICMJE June 18, 2019
Last Update Posted Date May 26, 2021
Actual Study Start Date  ICMJE September 20, 2019
Actual Primary Completion Date August 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • change from baseline in the isotopic ratio of iron in blood at week 2 [ Time Frame: 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 [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
  • Serum Ferritin concentration (µg/L) [ Time Frame: baseline, weeks 2, and 4 ]
    to assess iron status
  • Serum iron concentration (µg/dL) [ Time Frame: baseline, weeks 2, and 4 ]
    to assess iron status
  • Soluble transferrin receptor (mg/L) [ Time Frame: baseline, weeks 2, and 4 ]
    to assess iron status
  • Transferrin saturation in % [ Time Frame: 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) [ Time Frame: baseline, weeks 2, and 4 ]
    to assess blood volume based on weight, height, and Hb.
  • C-reactive Protein (mg/L) [ Time Frame: baseline, weeks 2, and 4 ]
    identify acute inflammation
  • alpha-1-glycoprotein (g/L) [ Time Frame: baseline, weeks 2, and 4 ]
    identify chronic inflammation
  • Serum Hepcidin (nM) [ Time Frame: baseline, and weeks 2 ]
    the major regulator of non-heme iron absorption
Original Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Iron status markers [ Time Frame: baseline, weeks 2, and 4 ]
    commonly measured iron status markers (Serum iron, transferrin saturation, Serum Ferritin, hemoglobin, and erythrocyte volume)
  • Hepcidin [ Time Frame: baseline, and weeks 2 ]
    fasting Serum hepcidin concentrations
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhibiting Dietary Iron Absorption in Subjects With Hereditary Hemochromatosis by a Natural Polyphenol Supplement
Official Title  ICMJE Testing the Efficacy of a Natural Polyphenol Supplement to Inhibit Dietary Iron Absorption in Subjects With Hereditary Hemochromatosis: a Stable Isotope Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE
  • Iron Metabolism Disorders
  • Iron Overload
  • Polyphenols
Intervention  ICMJE
  • Dietary Supplement: meal matrix & NPPS
    Test meal consumed with the natural polyphenol supplement
  • Dietary Supplement: meal matrix & CS
    Test meal consumed with the control supplement
  • Dietary Supplement: no-matrix & NPPS
    Test drink consumed with the natural polyphenol supplement
  • Dietary Supplement: no-matrix & CS
    Test drink consumed with the control supplement
Study Arms  ICMJE
  • Experimental: Meal & natural polyphenol supplement (NPPS)
    A meal, labelled with stable iron isotope as ferrous sulphate, consumed with the natural polyphenol supplement
    Intervention: Dietary Supplement: meal matrix & NPPS
  • Experimental: Drink & natural polyphenol supplement
    A drink, labelled with stable iron isotope as ferrous sulphate, consumed with the natural polyphenol supplement
    Intervention: Dietary Supplement: no-matrix & NPPS
  • Placebo Comparator: Meal & control supplement (CS)
    A meal, labelled with stable iron isotope as ferrous sulphate, consumed with a control supplement
    Intervention: Dietary Supplement: meal matrix & CS
  • Placebo Comparator: Drink & control supplement
    A drink, labelled with stable iron isotope as ferrous sulphate, consumed with a control supplement
    Intervention: Dietary Supplement: no-matrix & CS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 23, 2021) 		14
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2019) 		20
Actual Study Completion Date  ICMJE August 15, 2020
Actual Primary Completion Date August 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Portugal,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03990181
Other Study ID Numbers  ICMJE FePPHH
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
Study Sponsor  ICMJE Swiss Federal Institute of Technology
Collaborators  ICMJE Instituto de Investigação em Imunologia
Investigators  ICMJE Not Provided
PRS Account Swiss Federal Institute of Technology
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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