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COMPLETED
NCT03453918
NA

Effects of Polyphenols on Iron Absorption in Iron Overload Disorders.

Sponsor: University Hospital, Clermont-Ferrand

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

41

Start Date

2018-04-09

Completion Date

2018-07-20

Last Updated

2026-08-03

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

polyphenols

After 6 hours of fasting, each patient will eat a complete meal course, containing 40 mg of iron, at two different days (wash-out period: 3 days between each meal). During each meal, each patient will receive, two capsules containing polyphenols or two placebo capsules (cross-over methodology). The meal in which each patient will receive either polyphenol or placebo will be randomized. The diet consists of : * Starter: duck gizzard salad. * Main course: black pudding and pasta. * French cheese. * Fruits: kiwi fruit. This diet contain approximately 40 mg of iron, with low polyphenol intake. Patients will be asked to eat the whole gizzard and black pudding to ensure the highest iron intake. At the end of the meal, blood samples will be collected at 0 minute, 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours, to assess serum iron level, in order to measure the area under the curve of iron kinetic.

OTHER

Placebo

After 6 hours of fasting, each patient will eat a complete meal course, containing 40 mg of iron, at two different days (wash-out period: 3 days between each meal). During each meal, each patient will receive, two capsules containing polyphenols or two placebo capsules (cross-over methodology). The meal in which each patient will receive either polyphenol or placebo will be randomized. The diet consists of : * Starter: duck gizzard salad. * Main course: black pudding and pasta. * French cheese. * Fruits: kiwi fruit. This diet contain approximately 40 mg of iron, with low polyphenol intake. Patients will be asked to eat the whole gizzard and black pudding to ensure the highest iron intake. At the end of the meal, blood samples will be collected at 0 minute, 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours, to assess serum iron level, in order to measure the area under the curve of iron kinetic.

Locations (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France