ThalassemiaNCT05326503
Inhibitory Effect of a Polyphenol Supplement on Dietary Iron Absorption in Adults with Thalassemia
A study testing Meal matrix with polyphenol supplement (PPS) and No meal matrix with PPS in people with Thalassemia and Iron Overload, run by Swiss Federal Institute of Technology at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Thalassemia, Iron Overload
- What is being tested?
- Meal matrix with polyphenol supplement (PPS) and No meal matrix with PPS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2022to 11 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Meal matrix with polyphenol supplement (PPS), Meal matrix with placebo, No meal matrix with PPS, No meal matrix with placebo
- Keywords
- Iron overload, Thalassemia, Polyphenols, Iron absorption
- Medical subject headings
- Thalassemia, Iron Overload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal matrix with polyphenol supplement (PPS)Dietary supplement
Test meal with polyphenol supplement
Meal matrix with placeboDietary supplement
Test meal with placebo (maltodextrin) supplement
No meal matrix with PPSDietary supplement
Test drink with polyphenol supplement
No meal matrix with placeboDietary supplement
Test drink with placebo (maltodextrin) supplement
| Study group | Role | What they receive |
|---|---|---|
| Meal with polyphenol supplement (PPS) | Experimental | Iron-rich test meal labelled with stable iron isotope as ferrous sulfate, consumed with the polyphenol supplement. Receives: Dietary Supplement: Meal matrix with polyphenol supplement (PPS) |
| Meal with placebo | Placebo comparator | Iron-rich test meal labelled with stable iron isotope as ferrous sulfate, consumed with placebo supplement (maltodextrin). Receives: Dietary Supplement: Meal matrix with placebo |
| Drink with PPS | Experimental | Iron-fortified drink labelled with stable iron isotope as ferrous sulfate, consumed with the polyphenol supplement. Receives: Dietary Supplement: No meal matrix with PPS |
| Drink with placebo | Placebo comparator | Iron-fortified drink labelled with stable iron isotope as ferrous sulfate, consumed with placebo supplement (maltodextrin). Receives: Dietary Supplement: No meal matrix with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Measured 14 days after administration of last test drink (study day 18 or 35)
Secondary outcomes (7)
Serum ferritin (µg/L)
to assess iron status
Measured: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Soluble transferrin receptor (mg/L)
to assess iron status
Measured: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Transferrin saturation (%)
to assess iron status
Measured: 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
Measured: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
C-reactive protein (mg/L)
To assess inflammation status
Measured: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Alpha-1-glycoprotein (g/L),
To assess inflammation status
Measured: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Serum hepcidin (nM)
Major regulator of non-heme iron absorption
Measured: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start1 Jun 2022
- Primary completion11 Sep 2023
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThalassemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University
- Responsible party
- Sponsor
- Investigators
- Michael B Zimmermann, MD, PhD, Study director, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326503
- Sponsor's protocol ID
- Fe-PP-Thal
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2022
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Natural Polyphenol Supplement to Inhibit Dietary Iron Absorption in Thai Adults with Iron-loading Thalassemia: a Stable Isotope Study
- ClinicalTrials.gov ID
- NCT05326503
- Acronym / sponsor ID
- Fe-PP-Thal
- Conditions
- Thalassemia, Iron Overload
- Keywords
- Iron overload, Thalassemia, Polyphenols, Iron absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Mahidol University
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Meal with polyphenol supplement (PPS) | Experimental | Dietary Supplement: Meal matrix with polyphenol supplement (PPS)Iron-rich test meal labelled with stable iron isotope as ferrous sulfate, consumed with the polyphenol supplement. |
| Meal with placebo | Placebo comparator | Dietary Supplement: Meal matrix with placeboIron-rich test meal labelled with stable iron isotope as ferrous sulfate, consumed with placebo supplement (maltodextrin). |
| Drink with PPS | Experimental | Dietary Supplement: No meal matrix with PPSIron-fortified drink labelled with stable iron isotope as ferrous sulfate, consumed with the polyphenol supplement. |
| Drink with placebo | Placebo comparator | Dietary Supplement: No meal matrix with placeboIron-fortified drink labelled with stable iron isotope as ferrous sulfate, consumed with placebo supplement (maltodextrin). |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meal matrix with polyphenol supplement (PPS)Test meal with polyphenol supplement | Dietary supplement | Meal with polyphenol supplement (PPS) |
| Meal matrix with placeboTest meal with placebo (maltodextrin) supplement | Dietary supplement | Meal with placebo |
| No meal matrix with PPSTest drink with polyphenol supplement | Dietary supplement | Drink with PPS |
| No meal matrix with placeboTest drink with placebo (maltodextrin) supplement | Dietary supplement | Drink with placebo |
Primary outcome
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.
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.
7 secondary outcomes
Serum ferritin (µg/L)
Time frame: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Soluble transferrin receptor (mg/L)
Time frame: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Transferrin saturation (%)
Time frame: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Hemoglobin (g/dL)
Time frame: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
C-reactive protein (mg/L)
Time frame: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Alpha-1-glycoprotein (g/L),
Time frame: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Serum hepcidin (nM)
Time frame: At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Zimmermann, MD, PhD study director
ETH Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal matrix with polyphenol supplement (PPS) and No meal matrix with PPS in people with Thalassemia and Iron Overload, run by Swiss Federal Institute of Technology at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.