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Completed

NCT Number: NCT03990181

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

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.

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Key information

Conditions

Iron Metabolism Disorders Iron Overload Metabolic Diseases Nutritional and Metabolic Diseases Polyphenols

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Porto University Hospital Center, Porto, Portugal

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

meal matrix & NPPS

Dietary Supplement

Test meal consumed with the natural polyphenol supplement

meal matrix & CS

Dietary Supplement

Test meal consumed with the control supplement

no-matrix & NPPS

Dietary Supplement

Test drink consumed with the natural polyphenol supplement

no-matrix & CS

Dietary Supplement

Test drink consumed with the control supplement

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • Instituto de Investigação em Imunologia

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 18, 2019
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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