Iron Metabolism DisordersNCT03990181
Inhibiting Dietary Iron Absorption in Subjects With Hereditary Hemochromatosis by a Natural Polyphenol Supplement
A study testing meal matrix & NPPS, meal matrix & CS and no-matrix & NPPS in people with Iron Metabolism Disorders and Iron Overload, run by Swiss Federal Institute of Technology at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Metabolism Disorders, Iron Overload, Polyphenols
- What is being tested?
- meal matrix & NPPS, meal matrix & CS and no-matrix & NPPS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Sep 2019to 15 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
- Conditions
- Iron Metabolism Disorders, Iron Overload, Polyphenols
- Being tested
- meal matrix & NPPS, meal matrix & CS, no-matrix & NPPS, no-matrix & CS
- Medical subject headings
- Iron Metabolism Disorders, Iron Overload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meal matrix & NPPSDietary supplement
Test meal consumed with the natural polyphenol supplement
meal matrix & CSDietary supplement
Test meal consumed with the control supplement
no-matrix & NPPSDietary supplement
Test drink consumed with the natural polyphenol supplement
no-matrix & CSDietary supplement
Test drink consumed with the control supplement
| Study group | Role | What they receive |
|---|---|---|
| Meal & natural polyphenol supplement (NPPS) | Experimental | A meal, labelled with stable iron isotope as ferrous sulphate, consumed with the natural polyphenol supplement Receives: 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: no-matrix & CS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2 weeks, 4 weeks
Secondary outcomes (8)
Serum Ferritin concentration (µg/L)
to assess iron status
Measured: baseline, weeks 2, and 4
Serum iron concentration (µg/dL)
to assess iron status
Measured: baseline, weeks 2, and 4
Soluble transferrin receptor (mg/L)
to assess iron status
Measured: baseline, weeks 2, and 4
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)
Measured: baseline, weeks 2, and 4
Hemoglobin (g/dL)
to assess blood volume based on weight, height, and Hb.
Measured: baseline, weeks 2, and 4
C-reactive Protein (mg/L)
identify acute inflammation
Measured: baseline, weeks 2, and 4
alpha-1-glycoprotein (g/L)
identify chronic inflammation
Measured: baseline, weeks 2, and 4
Serum Hepcidin (nM)
the major regulator of non-heme iron absorption
Measured: baseline, and weeks 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start20 Sep 2019
- Primary completion15 Aug 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigação em Imunologia
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990181
- Sponsor's protocol ID
- FePPHH
- Status last verified
- May 2021
- First submitted
- 9 Jun 2019
- Last updated
- 26 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35320401
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of a Natural Polyphenol Supplement to Inhibit Dietary Iron Absorption in Subjects With Hereditary Hemochromatosis: a Stable Isotope Study
- ClinicalTrials.gov ID
- NCT03990181
- Acronym / sponsor ID
- FePPHH
- Conditions
- Iron Metabolism Disorders, Iron Overload, Polyphenols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Instituto de Investigação em Imunologia
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 18 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Meal & natural polyphenol supplement (NPPS) | Experimental | Dietary Supplement: meal matrix & NPPSA meal, labelled with stable iron isotope as ferrous sulphate, consumed with the natural polyphenol supplement |
| Drink & natural polyphenol supplement | Experimental | Dietary Supplement: no-matrix & NPPSA drink, labelled with stable iron isotope as ferrous sulphate, consumed with the natural polyphenol supplement |
| Meal & control supplement (CS) | Placebo comparator | Dietary Supplement: meal matrix & CSA meal, labelled with stable iron isotope as ferrous sulphate, consumed with a control supplement |
| Drink & control supplement | Placebo comparator | Dietary Supplement: no-matrix & CSA drink, labelled with stable iron isotope as ferrous sulphate, consumed with a control supplement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Homozygous for C282Y mutation in HFE (hemochromatosis) gene
- Written informed consent
- Age 18-65 y
- Not pregnant or lactating
- Body weight < 75 kg
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| meal matrix & NPPSTest meal consumed with the natural polyphenol supplement | Dietary supplement | Meal & natural polyphenol supplement (NPPS) |
| meal matrix & CSTest meal consumed with the control supplement | Dietary supplement | Meal & control supplement (CS) |
| no-matrix & NPPSTest drink consumed with the natural polyphenol supplement | Dietary supplement | Drink & natural polyphenol supplement |
| no-matrix & CSTest drink consumed with the control supplement | Dietary supplement | Drink & control supplement |
Primary outcome
change from baseline in the isotopic ratio of iron in blood at week 2
Time frame: baseline, 2 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 4
Time frame: 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
8 secondary outcomes
Serum Ferritin concentration (µg/L)
Time frame: baseline, weeks 2, and 4
Serum iron concentration (µg/dL)
Time frame: baseline, weeks 2, and 4
Soluble transferrin receptor (mg/L)
Time frame: baseline, weeks 2, and 4
Transferrin saturation in %
Time frame: baseline, weeks 2, and 4
Hemoglobin (g/dL)
Time frame: baseline, weeks 2, and 4
C-reactive Protein (mg/L)
Time frame: baseline, weeks 2, and 4
alpha-1-glycoprotein (g/L)
Time frame: baseline, weeks 2, and 4
Serum Hepcidin (nM)
Time frame: baseline, and weeks 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Derived from this study: PubMed 35320401Buerkli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing meal matrix & NPPS, meal matrix & CS and no-matrix & NPPS in people with Iron Metabolism Disorders and Iron Overload, run by Swiss Federal Institute of Technology at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in the isotopic ratio of iron in blood at week 2 (time frame: baseline, 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03990181, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.