An interventional study of Meal matrix with polyphenol supplement (PPS) and Meal matrix with placebo in Thalassemia and Iron Overload, sponsored by Swiss Federal Institute of Technology. Completed at 1 site in Thailand. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-05.
Sponsored by Swiss Federal Institute of Technology · Not applicable, Interventional, and Supportive care
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.
250 studies on the registry are indexed under Thalassemia; 43 are open to participants now.
This study's enrollment of 20 is below the median of 33 across 170 interventional studies indexed under Thalassemia.
Browse Thalassemia studies →Swiss Federal Institute of Technology is the lead sponsor of 154 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Iron-rich test meal labelled with stable iron isotope as ferrous sulfate, consumed with placebo supplement (maltodextrin).
Dietary Supplement: Meal matrix with placebo
Iron-fortified drink labelled with stable iron isotope as ferrous sulfate, consumed with the polyphenol supplement.
Dietary Supplement: No meal matrix with PPS
Iron-fortified drink labelled with stable iron isotope as ferrous sulfate, consumed with placebo supplement (maltodextrin).
Dietary Supplement: No meal matrix with placebo
Test meal with polyphenol supplement
Test meal with placebo (maltodextrin) supplement
Test drink with polyphenol supplement
Test drink with placebo (maltodextrin) supplement
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)
Ran from Jun 2022 to primary completion in Sep 2023, 15 months.
Of 18 interventional studies with no phase under Thalassemia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 87. This study's 15 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Swiss Federal Institute of Technology →