NCT05326503

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Swiss Federal Institute of Technology · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Thalassemia
• Iron Overload

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Meal matrix with polyphenol supplement (PPS)	Test meal with polyphenol supplement
DIETARY_SUPPLEMENT	Meal matrix with placebo	Test meal with placebo (maltodextrin) supplement
DIETARY_SUPPLEMENT	No meal matrix with PPS	Test drink with polyphenol supplement
DIETARY_SUPPLEMENT	No meal matrix with placebo	Test drink with placebo (maltodextrin) supplement

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-09-11
• Completion: 2023-09-11
• First posted: 2022-04-13
• Last updated: 2025-03-05

Locations

1 site across 1 country: Thailand