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

Iron Overload Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03990181
• Other study ID #: FePPHH
• Status: Completed
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: August 15, 2020

Study information

• Verified date: May 2021
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 15, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemochromatosis
• Iron Metabolism Disorders
• Iron Overload
• Metabolic Diseases
• Polyphenols

Intervention

Dietary Supplement:
• meal matrix & NPPS
Test meal consumed with the natural polyphenol supplement
• meal matrix & CS
Test meal consumed with the control supplement
• no-matrix & NPPS
Test drink consumed with the natural polyphenol supplement
• no-matrix & CS
Test drink consumed with the control supplement

Locations

Country	Name	City	State
Portugal	Porto University Hospital Center	Porto
Switzerland	Laboratory of Human Nutrition ETH Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Instituto de Investigação em Imunologia

Countries where clinical trial is conducted

Portugal,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in the isotopic ratio of iron in blood at week 2	The change in the isotopic ratio of iron will be measured after administration of a test meal/drink including iron isotopes	baseline, 2 weeks
Primary	change from baseline in the isotopic ratio of iron in blood at week 4	The change in the isotopic ratio of iron will be measured after administration of a test meal/drink including iron isotopes	2 weeks, 4 weeks
Secondary	Serum Ferritin concentration (µg/L)	to assess iron status	baseline, weeks 2, and 4
Secondary	Serum iron concentration (µg/dL)	to assess iron status	baseline, weeks 2, and 4
Secondary	Soluble transferrin receptor (mg/L)	to assess iron status	baseline, weeks 2, and 4
Secondary	Transferrin saturation in %	to calculate percent of transferrin that has iron bound to it; Plasma iron and transferrin saturation will be combined to calculate transferrin saturation (ratio)	baseline, weeks 2, and 4
Secondary	Hemoglobin (g/dL)	to assess blood volume based on weight, height, and Hb.	baseline, weeks 2, and 4
Secondary	C-reactive Protein (mg/L)	identify acute inflammation	baseline, weeks 2, and 4
Secondary	alpha-1-glycoprotein (g/L)	identify chronic inflammation	baseline, weeks 2, and 4
Secondary	Serum Hepcidin (nM)	the major regulator of non-heme iron absorption	baseline, and weeks 2