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

Thalassemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05326503
• Other study ID #: Fe-PP-Thal
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Swiss Federal Institute of Technology
• Contact: Jeannine Baumgartner, PhD
• Phone: +41 44 632 86 34
• Email: jeannine.baumgartner[@]hest.ethz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Documented diagnosis of thalassemia minor or intermedia (ß-thalassemia with or without a-globin gene mutations, Hb E/ß-thalassemia with or without a-globin gene mutations, or a-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
• 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

Related Conditions & MeSH terms

• Iron Overload
• Thalassemia

Intervention

Dietary Supplement:
• Meal matrix with polyphenol supplement (PPS)
Test meal with polyphenol supplement
• Meal matrix with placebo
Test meal with placebo (maltodextrin) supplement
• No meal matrix with PPS
Test drink with polyphenol supplement
• No meal matrix with placebo
Test drink with placebo (maltodextrin) supplement

Locations

Country	Name	City	State
Thailand	Mahidol University	Salaya

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 14 days after administration of last test meal (study day 18 or 35)
Primary	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 14 days after administration of last test drink (study day 18 or 35)
Secondary	Serum ferritin (µg/L)	to assess iron status	At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Secondary	Soluble transferrin receptor (mg/L)	to assess iron status	At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Secondary	Transferrin saturation (%)	to assess iron status	At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Secondary	Hemoglobin (g/dL)	to identify anemia and to determine blood volume	At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Secondary	C-reactive protein (mg/L)	To assess inflammation status	At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Secondary	Alpha-1-glycoprotein (g/L),	To assess inflammation status	At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)
Secondary	Serum hepcidin (nM)	Major regulator of non-heme iron absorption	At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35)