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

Federal Institute of Technology (ETH) Zurich

Status: Completed

Conditions: Iron Overload; Iron Metabolism Disorders; Polyphenols

Treatments: Dietary Supplement: no-matrix & NPPS; Dietary Supplement: meal matrix & NPPS; Dietary Supplement: meal matrix & CS; Dietary Supplement: no-matrix & CS

Study type: Interventional

Funder types: Other

Identifiers

NCT03990181

FePPHH

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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14 participants in 4 patient groups, including a placebo group

Meal & natural polyphenol supplement (NPPS)

Experimental group

Description:

A meal, labelled with stable iron isotope as ferrous sulphate, consumed with the natural polyphenol supplement

Treatment:

Dietary Supplement: meal matrix & NPPS

Drink & natural polyphenol supplement

Experimental group

Description:

A drink, labelled with stable iron isotope as ferrous sulphate, consumed with the natural polyphenol supplement

Treatment:

Dietary Supplement: no-matrix & NPPS

Meal & control supplement (CS)

Placebo Comparator group

Description:

A meal, labelled with stable iron isotope as ferrous sulphate, consumed with a control supplement

Treatment:

Dietary Supplement: meal matrix & CS

Drink & control supplement

Placebo Comparator group

Description:

A drink, labelled with stable iron isotope as ferrous sulphate, consumed with a control supplement

Treatment:

Dietary Supplement: no-matrix & CS