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Testing a Natural Polyphenol Supplement to Inhibit Dietary Iron Absorption in Thai Adults with Iron-loading Thalassemia: a Stable Isotope Study
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.
Age
18 - 49 years
Sex
ALL
Healthy Volunteers
Yes
Mahidol University
Salaya, Thailand
Start Date
June 1, 2022
Primary Completion Date
September 11, 2023
Completion Date
September 11, 2023
Last Updated
March 5, 2025
20
ACTUAL participants
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
DIETARY_SUPPLEMENT
Lead Sponsor
Swiss Federal Institute of Technology
Collaborators
NCT06647979
NCT07292259
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT03653338