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Report for Clinical Trial NCT03453918
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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.
NCT03453918 Dysmetabolic Iron Overload Syndrome Geneti Genetic Hemochromatosis Iron Absorption Polyphenols
2 Interventions
Name: polyphenols
Description: 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.
Type: Dietary Supplement
Group Labels: 1 Polyphenols
Name: Placebo
Description: 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.
Type: Other
Primary Outcomes
Description: decrease of intestinal iron absorption after standardized oral loading dose through rich-iron meal, expressed by area-under-the-curve of serum iron, due to concomitant administration of a single dose of dietary polyphenos (nutrient complement) versus placebo administration. This outcome is a quantitative variable, treated and analysed as such.
Measure: Decrease of post-prandial iron absorption after dietary polyphenol supplementation
Time: at day 3
Secondary Outcomes
Description: comparison of oxylipin levels, through lipidomic analyses by spectrophotometry
Measure: Post-prandial changes of circulating oxylipin in iron overload diseases after iron-rich meal and effects of polyphenols supplementation
Time: at day 1 (fasting versus 3 hours after rich-iron meal, versus 3 hours after rich-iron meal with polyphenol supplementation)
Description: comparison of oxylipin levels, through lipidomic analyses by spectrophotometry. Healthy subjects datas comes from a previous study (MEPHISTO).
Measure: Comparison of oxylipin levels between DIOS, genetic hemochromatosis and healthy subjects after 6 hours of fasting.
Time: at baseline
Purpose: Prevention
Allocation: Randomized
Crossover Assignment
There is one SNP
SNPs
- For Genetic Haemochromatosis type 1 Group: homozygosity mutation C282Y in HFE gene ;
patients undergoing therapeutic phlebotomies. --- C282Y ---
HPO Nodes