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NCT Number: NCT05326503

Inhibitory Effect of a Polyphenol Supplement on Dietary Iron Absorption in Adults with Thalassemia

Genetic disorders, such as thalassemia, can lead to iron overload and severe adverse health outcomes. In iron-loading thalassemia, iron overload is due to increased iron absorption. Iron accumulates in the body organs causing widespread damage. The standard treatment is iron chelation therapy and/or periodic phlebotomy to remove iron from the body; frequency of phlebotomy or chelation therapy is dependent on how quickly body iron stores accumulate.

Polyphenolic compounds are very strong inhibitors of non-heme iron absorption, as they form insoluble complexes with ferrous iron in the gastrointestinal tract that cannot be absorbed.

The investigators have recently shown in European subjects with hereditary hemochromatosis (another iron-loading disorder) that our newly-developed natural polyphenol supplement (PPS) that is rich in polyphenols, when taken with iron-rich meals or with an iron-fortified drink, reduces iron absorption by ~40%. Decreasing non-heme iron absorption in adults with iron-loading thalassemia could potentially lead to an extension of the time period between phlebotomies or chelation therapies, and therefore an improved quality of life.

Therefore, in this stable iron isotope study, the investigators will study the effect the natural PPS on oral iron absorption from an iron-rich test meal or iron-fortified drink in Thai adults with iron-loading thalassemia.

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Key information

Conditions

Thalassemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Iron Metabolism Disorders Iron Overload Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mahidol University

Salaya, Thailand

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Documented diagnosis of thalassemia minor or intermedia (β-thalassemia with or without α-globin gene mutations, Hb E/β-thalassemia with or without α-globin gene mutations, or α-thalassemia Hb H disease) based on Hb electrophoresis/HPLC and/or DNA analysis from the subject's medical record.
  • Hemoglobin (Hb): 7.0-13.5 g/dL for males; 7.0-12.0 for females
  • Serum ferritin (SF): 300-800 ug/L for males; 200-800 ug/L for females
  • Not having had a blood transfusion within 6 months prior to the study start
  • Age 18-49 y, not pregnant or lactating
  • Body weight <75 kg and body mass index (BMI) between 17 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 or blood transfusion during the study period
  • The last phlebotomy will be at least 4 weeks prior to first study visit
  • No intake of iron chelators 4 weeks prior to first study visit and throughout the study period
  • No use of medications affecting iron absorption or metabolism during the study
  • No intake of mineral/vitamin supplements 2 weeks prior to the first study visit and during the study
  • No participation in any other clinical study within the last 30 days and during the study
  • Expected to comply with study protocol

Treatment and study plan

Meal matrix with polyphenol supplement (PPS)

Dietary Supplement

Test meal with polyphenol supplement

Meal matrix with placebo

Dietary Supplement

Test meal with placebo (maltodextrin) supplement

No meal matrix with PPS

Dietary Supplement

Test drink with polyphenol supplement

No meal matrix with placebo

Dietary Supplement

Test drink with placebo (maltodextrin) supplement

Primary outcomes

  1. Difference in fractional iron absorption (FIA) from iron-rich test meal administered with and without the polyphenol supplement (PPS).

    Time frame: Measured 14 days after administration of last test meal (study day 18 or 35)

    FIA from labelled test meals consumed with the PPS and consumed with the placebo will be determined based on the shift of the iron isotope ratios in whole blood.

  2. Difference in FIA from iron-fortified test drink administered with and without the PPS.

    Time frame: Measured 14 days after administration of last test drink (study day 18 or 35)

    FIA from labelled test drink consumed with the PPS and consumed with the placebo will be determined based on the shift of the iron isotope ratios in whole blood.

Secondary outcomes

  1. Serum ferritin (µg/L)

    Time frame: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)

    to assess iron status

  2. Soluble transferrin receptor (mg/L)

    Time frame: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)

    to assess iron status

  3. Transferrin saturation (%)

    Time frame: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)

    to assess iron status

  4. Hemoglobin (g/dL)

    Time frame: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)

    to identify anemia and to determine blood volume

  5. C-reactive protein (mg/L)

    Time frame: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)

    To assess inflammation status

  6. Alpha-1-glycoprotein (g/L),

    Time frame: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)

    To assess inflammation status

  7. Serum hepcidin (nM)

    Time frame: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)

    Major regulator of non-heme iron absorption

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • Mahidol University

Registry information

Official study title

Testing a Natural Polyphenol Supplement to Inhibit Dietary Iron Absorption in Thai Adults with Iron-loading Thalassemia: a Stable Isotope Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 13, 2022
Registry last updated
Mar 5, 2025

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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