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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
20
Test meal with polyphenol supplement
Test meal with placebo (maltodextrin) supplement
Test drink with polyphenol supplement
Test drink with placebo (maltodextrin) supplement
Mahidol University
Salaya, Thailand
Difference in fractional iron absorption (FIA) from iron-rich test meal administered with and without the polyphenol supplement (PPS).
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.
Time frame: Measured 14 days after administration of last test meal (study day 18 or 35)
Difference in FIA from iron-fortified test drink administered with and without the PPS.
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.
Time frame: Measured 14 days after administration of last test drink (study day 18 or 35)
Serum ferritin (µg/L)
to assess iron status
Time frame: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Soluble transferrin receptor (mg/L)
to assess iron status
Time frame: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Transferrin saturation (%)
to assess iron status
Time frame: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Hemoglobin (g/dL)
to identify anemia and to determine blood volume
Time frame: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
C-reactive protein (mg/L)
To assess inflammation status
Time frame: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Alpha-1-glycoprotein (g/L),
To assess inflammation status
Time frame: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Serum hepcidin (nM)
Major regulator of non-heme iron absorption
Time frame: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
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