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Report for Clinical Trial NCT03990181

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Testing the Efficacy of a Natural Polyphenol Supplement to Inhibit Dietary Iron Absorption in Subjects With Hereditary Hemochromatosis: a Stable Isotope Study

Polyphenolic compounds are very strong Inhibitors of non-heme iron absorption, as they form insoluble complexes with ferrous iron. Patients with hereditary hemochromatosis (HH) have an increased intestinal non-heme iron absorption due to a genetic mutation in the regulatory pathway, leading to excess iron in the body. This study investigates the inhibitory effect of a natural polyphenol Supplement in participants with HH.

NCT03990181 Iron Metabolism Disorders Iron Overload Polyphenols
MeSH:Hemochromatosis Iron Overload Metabolic Diseases Iron Metabolism Disorders

4 Interventions

Name: meal matrix & NPPS

Description: Test meal consumed with the natural polyphenol supplement
Type: Dietary Supplement
Group Labels: 3

Meal Meal & Meal & natural polyphenol supplement (NPPS)

Name: meal matrix & CS

Description: Test meal consumed with the control supplement
Type: Dietary Supplement
Group Labels: 3

Meal Meal & Meal & control supplement (CS)

Name: no-matrix & NPPS

Description: Test drink consumed with the natural polyphenol supplement
Type: Dietary Supplement
Group Labels: 3

Drink Drink & Drink & natural polyphenol supplement

Name: no-matrix & CS

Description: Test drink consumed with the control supplement
Type: Dietary Supplement
Group Labels: 3

Drink Drink & Drink & control supplement


Primary Outcomes

Description: The change in the isotopic ratio of iron will be measured after administration of a test meal/drink including iron isotopes

Measure: change from baseline in the isotopic ratio of iron in blood at week 2

Time: baseline, 2 weeks

Description: The change in the isotopic ratio of iron will be measured after administration of a test meal/drink including iron isotopes

Measure: change from baseline in the isotopic ratio of iron in blood at week 4

Time: 2 weeks, 4 weeks

Secondary Outcomes

Description: to assess iron status

Measure: Serum Ferritin concentration (µg/L)

Time: baseline, weeks 2, and 4

Description: to assess iron status

Measure: Serum iron concentration (µg/dL)

Time: baseline, weeks 2, and 4

Description: to assess iron status

Measure: Soluble transferrin receptor (mg/L)

Time: baseline, weeks 2, and 4

Description: to calculate percent of transferrin that has iron bound to it; Plasma iron and transferrin saturation will be combined to calculate transferrin saturation (ratio)

Measure: Transferrin saturation in %

Time: baseline, weeks 2, and 4

Description: to assess blood volume based on weight, height, and Hb.

Measure: Hemoglobin (g/dL)

Time: baseline, weeks 2, and 4

Description: identify acute inflammation

Measure: C-reactive Protein (mg/L)

Time: baseline, weeks 2, and 4

Description: identify chronic inflammation

Measure: alpha-1-glycoprotein (g/L)

Time: baseline, weeks 2, and 4

Description: the major regulator of non-heme iron absorption

Measure: Serum Hepcidin (nM)

Time: baseline, and weeks 2

Purpose: Basic Science

Allocation: Randomized

Crossover Assignment


There is one SNP

SNPs


1 C282Y

Inclusion Criteria: - Homozygous for C282Y mutation in HFE (hemochromatosis) gene - Written informed consent - Age 18-65 y - Not pregnant or lactating - Body weight < 75 kg - Body mass index (BMI) between 18.5 and 25 kg/m2 - No acute illness/infection (self-reported) - No metabolic or gastrointestinal disorders, eating disorders or food allergy to the ingredients of the test meal (self-reported) - No scheduled phlebotomy throughout the study period - The last phlebotomy will be at least 4 weeks prior first test meal administration - No use of medications affecting iron absorption or metabolism during the study - No intake of mineral/vitamin supplements 2 weeks before the first study day and during the study - Participation in any other clinical study within the last 30 days - Expected to comply with study protocol Inclusion Criteria: - Homozygous for C282Y mutation in HFE (hemochromatosis) gene - Written informed consent - Age 18-65 y - Not pregnant or lactating - Body weight < 75 kg - Body mass index (BMI) between 18.5 and 25 kg/m2 - No acute illness/infection (self-reported) - No metabolic or gastrointestinal disorders, eating disorders or food allergy to the ingredients of the test meal (self-reported) - No scheduled phlebotomy throughout the study period - The last phlebotomy will be at least 4 weeks prior first test meal administration - No use of medications affecting iron absorption or metabolism during the study - No intake of mineral/vitamin supplements 2 weeks before the first study day and during the study - Participation in any other clinical study within the last 30 days - Expected to comply with study protocol Iron Metabolism Disorders Iron Overload Polyphenols Hemochromatosis Iron Overload Metabolic Diseases Iron Metabolism Disorders null --- C282Y ---

Inclusion Criteria: - Homozygous for C282Y mutation in HFE (hemochromatosis) gene - Written informed consent - Age 18-65 y - Not pregnant or lactating - Body weight < 75 kg - Body mass index (BMI) between 18.5 and 25 kg/m2 - No acute illness/infection (self-reported) - No metabolic or gastrointestinal disorders, eating disorders or food allergy to the ingredients of the test meal (self-reported) - No scheduled phlebotomy throughout the study period - The last phlebotomy will be at least 4 weeks prior first test meal administration - No use of medications affecting iron absorption or metabolism during the study - No intake of mineral/vitamin supplements 2 weeks before the first study day and during the study - Participation in any other clinical study within the last 30 days - Expected to comply with study protocol Inclusion Criteria: - Homozygous for C282Y mutation in HFE (hemochromatosis) gene - Written informed consent - Age 18-65 y - Not pregnant or lactating - Body weight < 75 kg - Body mass index (BMI) between 18.5 and 25 kg/m2 - No acute illness/infection (self-reported) - No metabolic or gastrointestinal disorders, eating disorders or food allergy to the ingredients of the test meal (self-reported) - No scheduled phlebotomy throughout the study period - The last phlebotomy will be at least 4 weeks prior first test meal administration - No use of medications affecting iron absorption or metabolism during the study - No intake of mineral/vitamin supplements 2 weeks before the first study day and during the study - Participation in any other clinical study within the last 30 days - Expected to comply with study protocol Iron Metabolism Disorders Iron Overload Polyphenols Hemochromatosis Iron Overload Metabolic Diseases Iron Metabolism Disorders null --- C282Y --- --- C282Y ---



HPO Nodes