Clinical Trials Logo
  1. Home
  2. Polyphenols
  3. NCT03453918

Effects of Polyphenols on Iron Absorption in Iron Overload Disorders. — POLYFER  

Iron Absorption Clinical Trial

Official title:
Effects of Polyphenols on Iron Absorption in Iron Overload Disorders.

Clinical Trial Summary

Dysmetabolic iron overload syndrome and genetic hemochromatosis are frequent causes of iron overload. Polyphenols are efficient iron-chelators. Investigator hypothesize that polyphenol supplementation can reduce iron absorption in iron overload disease. Iron absorption can be studied by the area-under-the-curve of serum iron after iron oral loading. The primary outcome is the decrease of post-prandial serum iron after rich-iron meal, due to polyphenol supplementation.

Clinical Trial Description

Iron overload diseases are highly prevalent. Dysmetabolic iron overload syndrome involves 15% of men with metabolic syndrome X. Genetic hemochromatosis is the most common genetic disease in Northern Europe. Both are due to a lack of regulation in iron absorption. To date, there is no nutritional study for those patients.

Polyphenols, particularly flavanols, have shown as good iron-chelating abilities as pharmacological chelators. However, no human study in iron-overload disease have been so far conducted.

The aim of POLYFER-study is to demonstrate that oral polyphenol intake reduces iron absorption in patients with genetic or metabolic iron-overload diseases.

POLYFER is a cross-over randomized controlled trial comparing the effect of polyphenol supplementation versus placebo on iron absorption after loading dose of iron given through a rich-iron meal. Iron absorption will be studied by the area under the curve of serum iron after the meal. Serum iron will be collected after the meal à 0 minute, 30 minutes, 1 hour, 2 hours, 3 hours et 4 hours.

Because of the nycthemeral variations of serum iron, it is essential to obtain a collection of serum iron data in the basal state (after fasting), allowing the calculation for each subject of a "relative" AUC after iron-rich meal with placebo and after iron-rich meal with polyphenols. The endpoint will be the difference between "relative" AUC after meal rich in iron alone and after polyphenols.

In order to improve the underlying mechanism of atherosclerosis which is highly prevalent in those diseases, we will conduct an ancillary study. Recent studies showed interesting results linking some oxylipins levels and inflammation. Investigator will study basal oxylipin level and post-prandial oxylipin level by lipidomic analysis in both diseases. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03453918
Study type Interventional
Source University Hospital, Clermont-Ferrand
Contact
Status Completed
Phase N/A
Start date April 9, 2018
Completion date July 20, 2018
View Details
See also
  Status Clinical Trial Phase
Completed NCT03310203 - The Relation Between Adiposity, Inflammation, Glycaemia and Iron Absorption N/A
Completed NCT01493297 - Effects of Vitamin A and Carotenoids on Iron Absorption N/A
Active, not recruiting NCT02979132 - Iron Long-Term Labelling Study Switzerland N/A
Completed NCT03586245 - Iron Absorption From Iron Enriched Aspergillus Oryzae in Females Using Stable Isotope Methodology N/A
Completed NCT04774016 - Iron Absorption From an Iron-fortified Follow-up Formula With Added Synbiotic or Human Milk Oligosaccharides N/A
Recruiting NCT06327529 - Zinc and Iron Absorption From Common Beans in Young Adult Women N/A
Active, not recruiting NCT02977806 - Iron Long-Term Labelling Study Malawi
Completed NCT02197624 - Genetic Variants and Iron Absorption N/A
Active, not recruiting NCT02979080 - Iron Long-Term Labelling Study Benin N/A
Recruiting NCT05973552 - Iron Absorption and Requirements in Pregnancy and Lactation
Completed NCT03894358 - Iron Absorption From a Wheat-based Instant Cereal:Gut and Stable Isotope Studies in Kenyan Infants N/A
Completed NCT01489007 - Iron Absorption in Vegetarian Children
Not yet recruiting NCT06236620 - Iron and Zinc Absorption in Flakes Derived From Sprouted or Hydrothermally Processed Wheat N/A
Completed NCT05266703 - Defining the Serum Ferritin Concentration in Kenyan Women at Which the Body Senses Iron Depletion and Begins to Upregulate Iron Absorption N/A
Completed NCT02228902 - Iron Absorption Trial Phase 4
Completed NCT01483092 - Effect of Inulin on Iron Absorption in Humans N/A
Completed NCT01423162 - Iron Bioavailability of Fortified Oat Drink Phase 4