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

Primary Purpose

Thalassemia, Iron Overload

Status

Not yet recruiting

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Meal matrix with polyphenol supplement (PPS)

Meal matrix with placebo

No meal matrix with PPS

No meal matrix with placebo

About this trial

This is an interventional supportive care trial for Thalassemia focused on measuring Iron overload, Thalassemia, Polyphenols, Iron absorption

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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
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

Sites / Locations

Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Meal with polyphenol supplement (PPS)

Meal with placebo

Drink with PPS

Drink with placebo

Arm Description

Iron-rich test meal labelled with stable iron isotope as ferrous sulfate, consumed with the polyphenol supplement.

Iron-rich test meal labelled with stable iron isotope as ferrous sulfate, consumed with placebo supplement (maltodextrin).

Iron-fortified drink labelled with stable iron isotope as ferrous sulfate, consumed with the polyphenol supplement.

Iron-fortified drink labelled with stable iron isotope as ferrous sulfate, consumed with placebo supplement (maltodextrin).

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Serum ferritin (µg/L)

to assess iron status

Soluble transferrin receptor (mg/L)

to assess iron status

Transferrin saturation (%)

to assess iron status

Hemoglobin (g/dL)

to identify anemia and to determine blood volume

C-reactive protein (mg/L)

To assess inflammation status

Alpha-1-glycoprotein (g/L),

To assess inflammation status

Serum hepcidin (nM)

Major regulator of non-heme iron absorption

Full Information

NCT ID

NCT05326503

First Posted

February 9, 2022

Last Updated

April 13, 2022

Sponsor

Swiss Federal Institute of Technology

Collaborators

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT05326503

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 1, 2022 (Anticipated)

Primary Completion Date

September 30, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Swiss Federal Institute of Technology

Collaborators

Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thalassemia, Iron Overload

Keywords

Iron overload, Thalassemia, Polyphenols, Iron absorption

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Meal with polyphenol supplement (PPS)

Arm Type

Experimental

Arm Description

Iron-rich test meal labelled with stable iron isotope as ferrous sulfate, consumed with the polyphenol supplement.

Arm Title

Meal with placebo

Arm Type

Placebo Comparator

Arm Description

Iron-rich test meal labelled with stable iron isotope as ferrous sulfate, consumed with placebo supplement (maltodextrin).

Arm Title

Drink with PPS

Arm Type

Experimental

Arm Description

Iron-fortified drink labelled with stable iron isotope as ferrous sulfate, consumed with the polyphenol supplement.

Arm Title

Drink with placebo

Arm Type

Placebo Comparator

Arm Description

Iron-fortified drink labelled with stable iron isotope as ferrous sulfate, consumed with placebo supplement (maltodextrin).

Intervention Type

Dietary Supplement

Intervention Name(s)

Meal matrix with polyphenol supplement (PPS)

Intervention Description

Test meal with polyphenol supplement

Intervention Type

Dietary Supplement

Intervention Name(s)

Meal matrix with placebo

Intervention Description

Test meal with placebo (maltodextrin) supplement

Intervention Type

Dietary Supplement

Intervention Name(s)

No meal matrix with PPS

Intervention Description

Test drink with polyphenol supplement

Intervention Type

Dietary Supplement

Intervention Name(s)

No meal matrix with placebo

Intervention Description

Test drink with placebo (maltodextrin) supplement

Primary Outcome Measure Information:

Title

Difference in fractional iron absorption (FIA) from iron-rich test meal administered with and without the polyphenol supplement (PPS).

Description

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)

Title

Difference in FIA from iron-fortified test drink administered with and without the PPS.

Description

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)

Secondary Outcome Measure Information:

Title

Serum ferritin (µg/L)

Description

to assess iron status

Time Frame