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| Name | Class |
|---|---|
| Instituto de Investigação em Imunologia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meal & natural polyphenol supplement (NPPS) | Experimental | A meal, labelled with stable iron isotope as ferrous sulphate, consumed with the natural polyphenol supplement |
|
| Drink & natural polyphenol supplement | Experimental | A drink, labelled with stable iron isotope as ferrous sulphate, consumed with the natural polyphenol supplement |
|
| Meal & control supplement (CS) | Placebo Comparator | A meal, labelled with stable iron isotope as ferrous sulphate, consumed with a control supplement |
|
| Drink & control supplement | Placebo Comparator | A drink, labelled with stable iron isotope as ferrous sulphate, consumed with a control supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| meal matrix & NPPS | Dietary Supplement | Test meal consumed with the natural polyphenol supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Ferritin concentration (µg/L) | to assess iron status | baseline, weeks 2, and 4 |
| Serum iron concentration (µg/dL) | to assess iron status |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Porto University Hospital Center | Porto | Portugal | ||||
| Laboratory of Human Nutrition ETH Zurich |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35320401 | Derived | 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. |
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| meal matrix & CS | Dietary Supplement | Test meal consumed with the control supplement |
|
| no-matrix & NPPS | Dietary Supplement | Test drink consumed with the natural polyphenol supplement |
|
| no-matrix & CS | Dietary Supplement | Test drink consumed with the control supplement |
|
| baseline, weeks 2, and 4 |
| Soluble transferrin receptor (mg/L) | to assess iron status | 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) | baseline, weeks 2, and 4 |
| Hemoglobin (g/dL) | to assess blood volume based on weight, height, and Hb. | baseline, weeks 2, and 4 |
| C-reactive Protein (mg/L) | identify acute inflammation | baseline, weeks 2, and 4 |
| alpha-1-glycoprotein (g/L) | identify chronic inflammation | baseline, weeks 2, and 4 |
| Serum Hepcidin (nM) | the major regulator of non-heme iron absorption | baseline, and weeks 2 |
| Zurich |
| Switzerland |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D019190 | Iron Overload |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C063701 | N-(3-pyridyl)-3-phenylsuccinimide |
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