SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03453918

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

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.

NCT03453918 Dysmetabolic Iron Overload Syndrome Genetic Hemochromatosis Iron Absorption Polyphenols
MeSH: Syndrome Iron Overload Hemochromatosis

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

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

Placebo


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


1 C282Y

- For Genetic Haemochromatosis type 1 Group: homozygosity mutation C282Y in HFE gene ; patients undergoing therapeutic phlebotomies. --- C282Y ---



HPO Nodes