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

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ClinicalTrials.gov Identifier: NCT05326503
Recruitment Status : Not yet recruiting
First Posted : April 13, 2022
Last Update Posted : April 14, 2022
Sponsor:
Collaborator:
Mahidol University
Information provided by (Responsible Party):
Swiss Federal Institute of Technology

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Thalassemia Iron Overload Dietary Supplement: Meal matrix with polyphenol supplement (PPS) Dietary Supplement: Meal matrix with placebo Dietary Supplement: No meal matrix with PPS Dietary Supplement: No meal matrix with placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Testing a Natural Polyphenol Supplement to Inhibit Dietary Iron Absorption in Thai Adults With Iron-loading Thalassemia: a Stable Isotope Study
Estimated Study Start Date : May 1, 2022
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Meal with polyphenol supplement (PPS)
Iron-rich test meal labelled with stable iron isotope as ferrous sulfate, consumed with the polyphenol supplement.
 Dietary Supplement: Meal matrix with polyphenol supplement (PPS)
Test meal with polyphenol supplement
Placebo Comparator: Meal with placebo
Iron-rich test meal labelled with stable iron isotope as ferrous sulfate, consumed with placebo supplement (maltodextrin).
 Dietary Supplement: Meal matrix with placebo
Test meal with placebo (maltodextrin) supplement
Experimental: Drink with PPS
Iron-fortified drink labelled with stable iron isotope as ferrous sulfate, consumed with the polyphenol supplement.
 Dietary Supplement: No meal matrix with PPS
Test drink with polyphenol supplement
Placebo Comparator: Drink with placebo
Iron-fortified drink labelled with stable iron isotope as ferrous sulfate, consumed with placebo supplement (maltodextrin).
 Dietary Supplement: No meal matrix with placebo
Test drink with placebo (maltodextrin) supplement


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05326503


Contacts
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Contact: Jeannine Baumgartner, PhD +41 44 632 86 34 jeannine.baumgartner@hest.ethz.ch
Contact: Michael B Zimmermann, MD, PhD +41 44 632 86 57 michael.zimmermann@hest.ethz.ch

Locations
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Thailand
Mahidol University
Salaya, Thailand
Contact: Sueppong Gowachirapant, PhD         
Sponsors and Collaborators
Swiss Federal Institute of Technology
Mahidol University
Investigators
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Study Director: Michael B Zimmermann, MD, PhD ETH Zurich
More Information
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Responsible Party: Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT05326503    
Other Study ID Numbers: Fe-PP-Thal
First Posted: April 13, 2022    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Swiss Federal Institute of Technology:
Iron overload
Thalassemia
Polyphenols
Iron absorption
Additional relevant MeSH terms:
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Thalassemia
Iron Overload
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases