Iron Absorption Clinical Trial
— POLYFEROfficial title:
Effects of Polyphenols on Iron Absorption in Iron Overload Disorders.
Verified date | March 2019 |
Source | University Hospital, Clermont-Ferrand |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Dysmetabolic iron overload syndrome and genetic hemochromatosis are frequent causes of iron overload. Polyphenols are efficient iron-chelators. Investigator hypothesize that polyphenol supplementation can reduce iron absorption in iron overload disease. Iron absorption can be studied by the area-under-the-curve of serum iron after iron oral loading. The primary outcome is the decrease of post-prandial serum iron after rich-iron meal, due to polyphenol supplementation.
Status | Completed |
Enrollment | 41 |
Est. completion date | July 20, 2018 |
Est. primary completion date | July 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years old and over - Written consent. - For DIOS Group : at least one criteria of the metabolic syndrome as defined by the International Diabetes Federation, associated with hepatic iron overload measured by MRI (at least 50 µmol/g) or by hepatic biopsy. - For Genetic Haemochromatosis type 1 Group: homozygosity mutation C282Y in HFE gene ; patients undergoing therapeutic phlebotomies. Exclusion Criteria: - Persons under guardianship - Body-weight less than 45 kg - Hemoglobin less than 9 g/dL. - Intestinal malabsorption of any cause - Current use or previous use during the last 2 months of iron supplement. - Current use or previous use during the last 2 months of treatment interacting with iron absorption (increasing like C vitamin or decreasing like iron chelators) - Other causes of hyperferritinemia : chronic inflammatory syndrome, porphyria, hyperferritinemia-cataract-syndrome, chronic alcohol consumption, chronic hemolysis. |
Country | Name | City | State |
---|---|---|---|
France | CHU Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Adams PC, Reboussin DM, Barton JC, McLaren CE, Eckfeldt JH, McLaren GD, Dawkins FW, Acton RT, Harris EL, Gordeuk VR, Leiendecker-Foster C, Speechley M, Snively BM, Holup JL, Thomson E, Sholinsky P; Hemochromatosis and Iron Overload Screening (HEIRS) Study Research Investigators. Hemochromatosis and iron-overload screening in a racially diverse population. N Engl J Med. 2005 Apr 28;352(17):1769-78. — View Citation
Allen KJ, Gurrin LC, Constantine CC, Osborne NJ, Delatycki MB, Nicoll AJ, McLaren CE, Bahlo M, Nisselle AE, Vulpe CD, Anderson GJ, Southey MC, Giles GG, English DR, Hopper JL, Olynyk JK, Powell LW, Gertig DM. Iron-overload-related disease in HFE hereditary hemochromatosis. N Engl J Med. 2008 Jan 17;358(3):221-30. doi: 10.1056/NEJMoa073286. — View Citation
Andersen SL, Gyrup C, Handberg A, Nielsen GL. Oral iron absorption test should not be performed with iron drops containing ferric iron. Dan Med J. 2015 Aug;62(8):A5116. — View Citation
Assi TB, Baz E. Current applications of therapeutic phlebotomy. Blood Transfus. 2014 Jan;12 Suppl 1:s75-83. doi: 10.2450/2013.0299-12. Epub 2013 Oct 3. Review. — View Citation
Beaton MD, Chakrabarti S, Levstik M, Speechley M, Marotta P, Adams P. Phase II clinical trial of phlebotomy for non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2013 Apr;37(7):720-9. doi: 10.1111/apt.12255. Epub 2013 Feb 26. — View Citation
Brissot P, Ropert M, Le Lan C, Loréal O. Non-transferrin bound iron: a key role in iron overload and iron toxicity. Biochim Biophys Acta. 2012 Mar;1820(3):403-10. doi: 10.1016/j.bbagen.2011.07.014. Epub 2011 Aug 9. Review. — View Citation
Brown KE, Dennery PA, Ridnour LA, Fimmel CJ, Kladney RD, Brunt EM, Spitz DR. Effect of iron overload and dietary fat on indices of oxidative stress and hepatic fibrogenesis in rats. Liver Int. 2003 Aug;23(4):232-42. — View Citation
Brune M, Rossander L, Hallberg L. Iron absorption and phenolic compounds: importance of different phenolic structures. Eur J Clin Nutr. 1989 Aug;43(8):547-57. — View Citation
Cook JD, Reddy MB, Hurrell RF. The effect of red and white wines on nonheme-iron absorption in humans. Am J Clin Nutr. 1995 Apr;61(4):800-4. — View Citation
Ganz T. Systemic iron homeostasis. Physiol Rev. 2013 Oct;93(4):1721-41. doi: 10.1152/physrev.00008.2013. Review. — View Citation
Gladine C, Newman JW, Durand T, Pedersen TL, Galano JM, Demougeot C, Berdeaux O, Pujos-Guillot E, Mazur A, Comte B. Lipid profiling following intake of the omega 3 fatty acid DHA identifies the peroxidized metabolites F4-neuroprostanes as the best predictors of atherosclerosis prevention. PLoS One. 2014 Feb 18;9(2):e89393. doi: 10.1371/journal.pone.0089393. eCollection 2014. — View Citation
Gouveia-Figueira S, Späth J, Zivkovic AM, Nording ML. Profiling the Oxylipin and Endocannabinoid Metabolome by UPLC-ESI-MS/MS in Human Plasma to Monitor Postprandial Inflammation. PLoS One. 2015 Jul 17;10(7):e0132042. doi: 10.1371/journal.pone.0132042. eCollection 2015. — View Citation
Grapov D, Adams SH, Pedersen TL, Garvey WT, Newman JW. Type 2 diabetes associated changes in the plasma non-esterified fatty acids, oxylipins and endocannabinoids. PLoS One. 2012;7(11):e48852. doi: 10.1371/journal.pone.0048852. Epub 2012 Nov 8. — View Citation
Gutteridge JM, Rowley DA, Griffiths E, Halliwell B. Low-molecular-weight iron complexes and oxygen radical reactions in idiopathic haemochromatosis. Clin Sci (Lond). 1985 Apr;68(4):463-7. — View Citation
Hoppe M, Hulthén L, Hallberg L. Serum iron concentration as a tool to measure relative iron absorption from elemental iron powders in man. Scand J Clin Lab Invest. 2003;63(7-8):489-96. — View Citation
Hoppe M, Hulthén L. Validation of the clinical approach of using the induced serum iron increase after 1h as a measure of iron absorption. Clin Nutr. 2006 Feb;25(1):163-5. Epub 2005 Nov 22. — View Citation
Hurrell RF, Reddy M, Cook JD. Inhibition of non-haem iron absorption in man by polyphenolic-containing beverages. Br J Nutr. 1999 Apr;81(4):289-95. — View Citation
Jouanolle AM, Fergelot P, Gandon G, Yaouanq J, Le Gall JY, David V. A candidate gene for hemochromatosis: frequency of the C282Y and H63D mutations. Hum Genet. 1997 Oct;100(5-6):544-7. — View Citation
Kim J, Carlson ME, Kuchel GA, Newman JW, Watkins BA. Dietary DHA reduces downstream endocannabinoid and inflammatory gene expression and epididymal fat mass while improving aspects of glucose use in muscle in C57BL/6J mice. Int J Obes (Lond). 2016 Jan;40(1):129-37. doi: 10.1038/ijo.2015.135. Epub 2015 Jul 29. — View Citation
Kloepfer K, Schmid P, Wuillemin WA, Rüfer A. Reference values for oral iron absorption of bivalent iron in healthy volunteers. Swiss Med Wkly. 2015 Jan 22;145:w14063. doi: 10.4414/smw.2015.14063. eCollection 2015. — View Citation
Kobune M, Miyanishi K, Takada K, Kawano Y, Nagashima H, Kikuchi S, Murase K, Iyama S, Sato T, Sato Y, Takimoto R, Kato J. Establishment of a simple test for iron absorption from the gastrointestinal tract. Int J Hematol. 2011 Jun;93(6):715-719. doi: 10.1007/s12185-011-0878-8. Epub 2011 Jun 1. — View Citation
Le Guenno G, Chanséaume E, Ruivard M, Morio B, Mazur A. Study of iron metabolism disturbances in an animal model of insulin resistance. Diabetes Res Clin Pract. 2007 Sep;77(3):363-70. Epub 2007 Mar 9. — View Citation
Lobbes H, Gladine C, Mazur A, Pereira B, Dualé C, Cardot JM, Ruivard M. Effect of procyanidin on dietary iron absorption in hereditary hemochromatosis and in dysmetabolic iron overload syndrome: A crossover double-blind randomized controlled trial. Clin Nutr. 2019 Feb 11. pii: S0261-5614(19)30066-4. doi: 10.1016/j.clnu.2019.02.012. [Epub ahead of print] — View Citation
Mendler MH, Turlin B, Moirand R, Jouanolle AM, Sapey T, Guyader D, Le Gall JY, Brissot P, David V, Deugnier Y. Insulin resistance-associated hepatic iron overload. Gastroenterology. 1999 Nov;117(5):1155-63. — View Citation
Moukette BM, Pieme CA, Njimou JR, Biapa CP, Marco B, Ngogang JY. In vitro antioxidant properties, free radicals scavenging activities of extracts and polyphenol composition of a non-timber forest product used as spice: Monodora myristica. Biol Res. 2015 Mar 14;48:15. doi: 10.1186/s40659-015-0003-1. — View Citation
Rametta R, Dongiovanni P, Pelusi S, Francione P, Iuculano F, Borroni V, Fatta E, Castagna A, Girelli D, Fargion S, Valenti L. Hepcidin resistance in dysmetabolic iron overload. Liver Int. 2016 Oct;36(10):1540-8. doi: 10.1111/liv.13124. Epub 2016 Apr 6. — View Citation
Ríos-Hoyo A, Cortés MJ, Ríos-Ontiveros H, Meaney E, Ceballos G, Gutiérrez-Salmeán G. Obesity, Metabolic Syndrome, and Dietary Therapeutical Approaches with a Special Focus on Nutraceuticals (Polyphenols): A Mini-Review. Int J Vitam Nutr Res. 2014;84(3-4):113-23. doi: 10.1024/0300-9831/a000198. Review. — View Citation
Ruivard M, Feillet-Coudray C, Rambeau M, Gerbaud L, Mazur A, Rayssiguier Y, Philippe P, Coudray C. Effect of daily versus twice weekly long-term iron supplementation on iron absorption and status in iron-deficient women: a stable isotope study. Clin Biochem. 2006 Jul;39(7):700-7. Epub 2006 Apr 5. — View Citation
Ruivard M, Lainé F, Ganz T, Olbina G, Westerman M, Nemeth E, Rambeau M, Mazur A, Gerbaud L, Tournilhac V, Abergel A, Philippe P, Deugnier Y, Coudray C. Iron absorption in dysmetabolic iron overload syndrome is decreased and correlates with increased plasma hepcidin. J Hepatol. 2009 Jun;50(6):1219-25. doi: 10.1016/j.jhep.2009.01.029. Epub 2009 Apr 5. — View Citation
Sjödin P, Wallin H, Alexander J, Jägerstad M. Disposition and metabolism of the food mutagen 2-amino-3,8-dimethylimidazo[4,5-f]quinoxaline (MeIQx) in rats. Carcinogenesis. 1989 Jul;10(7):1269-75. — View Citation
Tako E, Beebe SE, Reed S, Hart JJ, Glahn RP. Polyphenolic compounds appear to limit the nutritional benefit of biofortified higher iron black bean (Phaseolus vulgaris L.). Nutr J. 2014 Mar 26;13:28. doi: 10.1186/1475-2891-13-28. — View Citation
Tako E, Reed SM, Budiman J, Hart JJ, Glahn RP. Higher iron pearl millet (Pennisetum glaucum L.) provides more absorbable iron that is limited by increased polyphenolic content. Nutr J. 2015 Jan 23;14:11. doi: 10.1186/1475-2891-14-11. — View Citation
Tondeur MC, Schauer CS, Christofides AL, Asante KP, Newton S, Serfass RE, Zlotkin SH. Determination of iron absorption from intrinsically labeled microencapsulated ferrous fumarate (sprinkles) in infants with different iron and hematologic status by using a dual-stable-isotope method. Am J Clin Nutr. 2004 Nov;80(5):1436-44. — View Citation
Tsuchiya H, Ebata Y, Sakabe T, Hama S, Kogure K, Shiota G. High-fat, high-fructose diet induces hepatic iron overload via a hepcidin-independent mechanism prior to the onset of liver steatosis and insulin resistance in mice. Metabolism. 2013 Jan;62(1):62-9. doi: 10.1016/j.metabol.2012.06.008. Epub 2012 Jul 30. — View Citation
Tuntawiroon M, Sritongkul N, Brune M, Rossander-Hultén L, Pleehachinda R, Suwanik R, Hallberg L. Dose-dependent inhibitory effect of phenolic compounds in foods on nonheme-iron absorption in men. Am J Clin Nutr. 1991 Feb;53(2):554-7. — View Citation
* Note: There are 35 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decrease of post-prandial iron absorption after dietary polyphenol supplementation | decrease of intestinal iron absorption after standardized oral loading dose through rich-iron meal, expressed by area-under-the-curve of serum iron, due to concomitant administration of a single dose of dietary polyphenos (nutrient complement) versus placebo administration. This outcome is a quantitative variable, treated and analysed as such. | at day 3 | |
Secondary | Post-prandial changes of circulating oxylipin in iron overload diseases after iron-rich meal and effects of polyphenols supplementation | comparison of oxylipin levels, through lipidomic analyses by spectrophotometry | at day 1 (fasting versus 3 hours after rich-iron meal, versus 3 hours after rich-iron meal with polyphenol supplementation) | |
Secondary | Comparison of oxylipin levels between DIOS, genetic hemochromatosis and healthy subjects after 6 hours of fasting. | comparison of oxylipin levels, through lipidomic analyses by spectrophotometry. Healthy subjects datas comes from a previous study (MEPHISTO). | at baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03310203 -
The Relation Between Adiposity, Inflammation, Glycaemia and Iron Absorption
|
N/A | |
Completed |
NCT01493297 -
Effects of Vitamin A and Carotenoids on Iron Absorption
|
N/A | |
Active, not recruiting |
NCT02979132 -
Iron Long-Term Labelling Study Switzerland
|
N/A | |
Completed |
NCT03586245 -
Iron Absorption From Iron Enriched Aspergillus Oryzae in Females Using Stable Isotope Methodology
|
N/A | |
Completed |
NCT04774016 -
Iron Absorption From an Iron-fortified Follow-up Formula With Added Synbiotic or Human Milk Oligosaccharides
|
N/A | |
Recruiting |
NCT06327529 -
Zinc and Iron Absorption From Common Beans in Young Adult Women
|
N/A | |
Active, not recruiting |
NCT02977806 -
Iron Long-Term Labelling Study Malawi
|
||
Completed |
NCT02197624 -
Genetic Variants and Iron Absorption
|
N/A | |
Active, not recruiting |
NCT02979080 -
Iron Long-Term Labelling Study Benin
|
N/A | |
Recruiting |
NCT05973552 -
Iron Absorption and Requirements in Pregnancy and Lactation
|
||
Completed |
NCT03894358 -
Iron Absorption From a Wheat-based Instant Cereal:Gut and Stable Isotope Studies in Kenyan Infants
|
N/A | |
Completed |
NCT01489007 -
Iron Absorption in Vegetarian Children
|
||
Not yet recruiting |
NCT06236620 -
Iron and Zinc Absorption in Flakes Derived From Sprouted or Hydrothermally Processed Wheat
|
N/A | |
Completed |
NCT05266703 -
Defining the Serum Ferritin Concentration in Kenyan Women at Which the Body Senses Iron Depletion and Begins to Upregulate Iron Absorption
|
N/A | |
Completed |
NCT02228902 -
Iron Absorption Trial
|
Phase 4 | |
Completed |
NCT01423162 -
Iron Bioavailability of Fortified Oat Drink
|
Phase 4 | |
Completed |
NCT01483092 -
Effect of Inulin on Iron Absorption in Humans
|
N/A |