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

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.

Conditions

• Thalassemia
• Iron Overload

Interventions

DIETARY_SUPPLEMENT

Meal matrix with polyphenol supplement (PPS)

Test meal with polyphenol supplement

DIETARY_SUPPLEMENT

Meal matrix with placebo

Test meal with placebo (maltodextrin) supplement

DIETARY_SUPPLEMENT

No meal matrix with PPS

Test drink with polyphenol supplement

DIETARY_SUPPLEMENT

No meal matrix with placebo

Test drink with placebo (maltodextrin) supplement

Sponsors & Collaborators

• Mahidol University

  collaborator OTHER

• Swiss Federal Institute of Technology

  lead OTHER

Principal Investigators

• Michael B Zimmermann, MD, PhD · ETH Zurich

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-06-01

Primary Completion

2023-09-11

Completion

2023-09-11

Countries

• Thailand

Study Locations