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

NCT03990181 | Completed

• 1 other identifier: FePPHH
• Study Type: interventional
• Target: 14
• Locations: 2 countries
• Sites: 2

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.

Conditions

Iron Metabolism Disorders; Iron Overload; Polyphenols

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Serum Ferritin concentration (µg/L)

  baseline, weeks 2, and 4

• Serum iron concentration (µg/dL)

  baseline, weeks 2, and 4

• Soluble transferrin receptor (mg/L)

  baseline, weeks 2, and 4

• Transferrin saturation in %

  baseline, weeks 2, and 4

• Hemoglobin (g/dL)

  baseline, weeks 2, and 4

Study Arms (4)

Meal & natural polyphenol supplement (NPPS)

EXPERIMENTAL

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

Dietary Supplement: meal matrix & NPPS

Drink & natural polyphenol supplement

EXPERIMENTAL

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

Dietary Supplement: no-matrix & NPPS

Meal & control supplement (CS)

PLACEBO COMPARATOR

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

Dietary Supplement: meal matrix & CS

Drink & control supplement

PLACEBO COMPARATOR

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

Dietary Supplement: no-matrix & CS

Interventions

meal matrix & NPPS DIETARY_SUPPLEMENT

Test meal consumed with the natural polyphenol supplement

Meal & natural polyphenol supplement (NPPS)

meal matrix & CS DIETARY_SUPPLEMENT

Test meal consumed with the control supplement

Meal & control supplement (CS)

no-matrix & NPPS DIETARY_SUPPLEMENT

Test drink consumed with the natural polyphenol supplement

Drink & natural polyphenol supplement

no-matrix & CS DIETARY_SUPPLEMENT

Test drink consumed with the control supplement

Drink & control supplement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Instituto de Investigação em Imunologia: collaborator

Study Sites (2)

Porto University Hospital Center

Porto, Portugal

Location

Laboratory of Human Nutrition ETH Zurich

Zurich, Switzerland

Location

Related Publications (1)

• Buerkli S, Salvioni L, Koller N, Zeder C, Teles MJ, Porto G, Habermann JH, Dubach IL, Vallelian F, Frey BM, Moretti D, Baumgartner J, Zimmermann MB. The effect of a natural polyphenol supplement on iron absorption in adults with hereditary hemochromatosis. Eur J Nutr. 2022 Sep;61(6):2967-2977. doi: 10.1007/s00394-022-02829-8. Epub 2022 Mar 23.

  PMID: 35320401 DERIVED

MeSH Terms

Conditions

Iron Metabolism Disorders; Iron Overload

Interventions

N-(3-pyridyl)-3-phenylsuccinimide

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Laboratory of Human Nutrition

Study Record Dates

• First Submitted: June 9, 2019
• First Posted: June 18, 2019
• Study Start: September 20, 2019
• Primary Completion: August 15, 2020
• Study Completion: August 15, 2020
• Last Updated: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); PT (1)