Inhibiting Dietary Iron Absorption in Subjects With Hereditary Hemochromatosis by a Natural Polyphenol Supplement

Not Applicable

Completed

• Conditions: Iron Overload; Iron Metabolism Disorders; Polyphenols
• Interventions: Dietary Supplement: meal matrix & NPPS; Dietary Supplement: meal matrix & CS; Dietary Supplement: no-matrix & CS; Dietary Supplement: no-matrix & NPPS

• Registration Number: NCT03990181
• Lead Sponsor: Swiss Federal Institute of Technology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-09
• Study First Submitted QC: 2019-06-17
• Study First Posted: 2019-06-18
• Study Start: 2019-09-20
• Primary Completion: 2020-08-15
• Study Completion: 2020-08-15
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-23
• Last Update Posted: 2021-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Meal & natural polyphenol supplement (NPPS)	meal matrix & NPPS	A meal, labelled with stable iron isotope as ferrous sulphate, consumed with the natural polyphenol supplement
Meal & control supplement (CS)	meal matrix & CS	A meal, labelled with stable iron isotope as ferrous sulphate, consumed with a control supplement
Drink & control supplement	no-matrix & CS	A drink, labelled with stable iron isotope as ferrous sulphate, consumed with a control supplement
Drink & natural polyphenol supplement	no-matrix & NPPS	A drink, labelled with stable iron isotope as ferrous sulphate, consumed with the natural polyphenol supplement

Primary Outcome Measures

Name	Time	Method
change from baseline in the isotopic ratio of iron in blood at week 4	2 weeks, 4 weeks	The change in the isotopic ratio of iron will be measured after administration of a test meal/drink including iron isotopes
change from baseline in the isotopic ratio of iron in blood at week 2	baseline, 2 weeks	The change in the isotopic ratio of iron will be measured after administration of a test meal/drink including iron isotopes

Secondary Outcome Measures

Name	Time	Method
Hemoglobin (g/dL)	baseline, weeks 2, and 4	to assess blood volume based on weight, height, and Hb.
Serum Ferritin concentration (µg/L)	baseline, weeks 2, and 4	to assess iron status
Serum iron concentration (µg/dL)	baseline, weeks 2, and 4	to assess iron status
Soluble transferrin receptor (mg/L)	baseline, weeks 2, and 4	to assess iron status
Transferrin saturation in %	baseline, weeks 2, and 4	to calculate percent of transferrin that has iron bound to it; Plasma iron and transferrin saturation will be combined to calculate transferrin saturation (ratio)
C-reactive Protein (mg/L)	baseline, weeks 2, and 4	identify acute inflammation
alpha-1-glycoprotein (g/L)	baseline, weeks 2, and 4	identify chronic inflammation
Serum Hepcidin (nM)	baseline, and weeks 2	the major regulator of non-heme iron absorption

Trial Locations

Locations (2)

Laboratory of Human Nutrition ETH Zurich; 🇨🇭 Zurich, Switzerland

Porto University Hospital Center; 🇵🇹 Porto, Portugal