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