NCT06232642|Unknown
Effects of Lactoferrin-enriched Whey on Iron Status in Females
The Effects of Lactoferrin and Iron-enriched Whey on Iron Status of Active Collegiate Females
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The Effects of Lactoferrin and Iron-enriched Whey on Iron Status of Active Collegiate Females
Sponsor study identifier
interventional
82
1 country
1
Study Start
March 1, 2024
Actual (reported)Primary Completion
May 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The goal of this work is to study the effects of twice daily ingestion of a whey protein, rice protein, or maltodextrin drink enriched with lactoferrin- (200 mg), iron (6 mg) and vitamin B12 (5.2 µg) for 16-weeks on iron metabolism and inflammatory markers in active young females. It is expected that the females consuming containing lactoferrin-, iron, and vitamin B12-enriched whey will 1) improve serum ferritin status; 2) reduce inflammation; 3) improve markers of iron metabolism, such as Hemoglobin (Hb), red blood cell count (RBC) and hematocrit (Hc) compared to women who consume the rice protein or maltodextrin control drink. Blood will be drawn before the beginning of the supplemental period (week 0) and end the end of the intervention phase (week 16).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 4, 2024
Actual (reported)January 31, 2024
Actual (reported)March 1, 2024
Actual (reported)May 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Serum Ferritin
Free Serum Ferritin measured via enzymatic detection at LabCorp Inc. as proxy of iron absorption.
Tested at week 0 before supplementation begins, and week 16 after the final supplements have been taken.
Inflammatory cytokine biomarker (IL-6) concentrations in plasma samples
Tested at week 0 before supplementation begins, and week 16 after the final supplements have been taken.
Inflammatory cytokine biomarker (C-reactive protein) concentrations in plasma samples
Tested at week 0 before supplementation begins, and week 16 after the final supplements have been taken.
Inflammatory cytokine biomarker (TNF-alpha) concentrations in plasma samples
Tested at week 0 before supplementation begins, and week 16 after the final supplements have been taken.
Marker of Iron metabolism Red Blood Cell Count
Tested at week 0 before supplementation begins, and on week 16 after the final supplements have been taken.
Marker of Iron metabolism Hematocrit
Tested at week 0 before supplementation begins, and week 16 after the final supplements have been taken.
Lactoferrin (200 mg), iron (6 mg), and B12 (5.2 ug) in a whey protein isolate drink (20 grams of protein) to be taken 2 times daily; once before the morning meal and once before the evening meal.
Lactoferrin (200 mg), iron (6 mg), and B12 (5.2 ug) in a rice protein drink (20 grams of protein) to be taken 2 times daily; once before the morning meal and once before the evening meal.
Chocolate Flavored Whey Protein Isolate Powder with (200mg Lactoferrin, 6 mg Iron, 5.2 ug B12)
Chocolate Flavored Rice Protein Isolate with (200mg Lactoferrin, 6mg Iron, 5.2 ug B12)
Center for Human Nutrition Studies
Logan, Utah, 84322, United States
Sun H, Weaver CM. Decreased Iron Intake Parallels Rising Iron Deficiency Anemia and Related Mortality Rates in the US Population. J Nutr. 2021 Jul 1;151(7):1947-1955. doi: 10.1093/jn/nxab064.
Rosa L, Lepanto MS, Cutone A, Siciliano RA, Paesano R, Costi R, Musci G, Valenti P. Influence of oral administration mode on the efficacy of commercial bovine Lactoferrin against iron and inflammatory homeostasis disorders. Biometals. 2020 Jun;33(2-3):159-168. doi: 10.1007/s10534-020-00236-2. Epub 2020 Apr 9.
82 participants (actual enrollment reported by the registry).
First Submitted
January 4, 2024
Lactoferrin (200 mg), iron (6 mg), and B12 (5.2 ug) in a maltodextrin drink (0 grams of protein) to be taken 2 times daily; once before the morning meal and once before the evening meal.
Chocolate Flavored (200mg Lactoferrin, 6 mg Iron, 5.2 ug B12)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Rezk M, Dawood R, Abo-Elnasr M, Al Halaby A, Marawan H. Lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy: a randomized clinical trial. J Matern Fetal Neonatal Med. 2016;29(9):1387-90. doi: 10.3109/14767058.2015.1049149. Epub 2015 Jun 3.
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Omar OM, Assem H, Ahmed D, Abd Elmaksoud MS. Lactoferrin versus iron hydroxide polymaltose complex for the treatment of iron deficiency anemia in children with cerebral palsy: a randomized controlled trial. Eur J Pediatr. 2021 Aug;180(8):2609-2618. doi: 10.1007/s00431-021-04125-9. Epub 2021 May 28.
Mikulic N, Uyoga MA, Mwasi E, Stoffel NU, Zeder C, Karanja S, Zimmermann MB. Iron Absorption is Greater from Apo-Lactoferrin and is Similar Between Holo-Lactoferrin and Ferrous Sulfate: Stable Iron Isotope Studies in Kenyan Infants. J Nutr. 2020 Dec 10;150(12):3200-3207. doi: 10.1093/jn/nxaa226.
Lonnerdal B, Du X, Jiang R. Biological activities of commercial bovine lactoferrin sources. Biochem Cell Biol. 2021 Feb;99(1):35-46. doi: 10.1139/bcb-2020-0182. Epub 2020 Jul 24.
Lepanto MS, Rosa L, Cutone A, Conte MP, Paesano R, Valenti P. Efficacy of Lactoferrin Oral Administration in the Treatment of Anemia and Anemia of Inflammation in Pregnant and Non-pregnant Women: An Interventional Study. Front Immunol. 2018 Sep 21;9:2123. doi: 10.3389/fimmu.2018.02123. eCollection 2018.
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Ke C, Lan Z, Hua L, Ying Z, Humina X, Jia S, Weizheng T, Ping Y, Lingying C, Meng M. Iron metabolism in infants: influence of bovine lactoferrin from iron-fortified formula. Nutrition. 2015 Feb;31(2):304-9. doi: 10.1016/j.nut.2014.07.006. Epub 2014 Aug 1.
El-Hawy MA, Abd Al-Salam SA, Bahbah WA. Comparing oral iron bisglycinate chelate, lactoferrin, lactoferrin with iron and iron polymaltose complex in the treatment of children with iron deficiency anemia. Clin Nutr ESPEN. 2021 Dec;46:367-371. doi: 10.1016/j.clnesp.2021.08.040. Epub 2021 Sep 29.
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Artym J, Zimecki M, Kruzel ML. Lactoferrin for Prevention and Treatment of Anemia and Inflammation in Pregnant Women: A Comprehensive Review. Biomedicines. 2021 Jul 27;9(8):898. doi: 10.3390/biomedicines9080898.
Pasricha SR, Tye-Din J, Muckenthaler MU, Swinkels DW. Iron deficiency. Lancet. 2021 Jan 16;397(10270):233-248. doi: 10.1016/S0140-6736(20)32594-0. Epub 2020 Dec 4.
GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2.
Miller EM. Iron status and reproduction in US women: National Health and Nutrition Examination Survey, 1999-2006. PLoS One. 2014 Nov 6;9(11):e112216. doi: 10.1371/journal.pone.0112216. eCollection 2014.
Koury MJ, Ponka P. New insights into erythropoiesis: the roles of folate, vitamin B12, and iron. Annu Rev Nutr. 2004;24:105-31. doi: 10.1146/annurev.nutr.24.012003.132306.
Koikawa N, Nagaoka I, Yamaguchi M, Hamano H, Yamauchi K, Sawaki K. Preventive effect of lactoferrin intake on anemia in female long distance runners. Biosci Biotechnol Biochem. 2008 Apr;72(4):931-5. doi: 10.1271/bbb.70383. Epub 2008 Apr 7.
Suzuki YA, Shin K, Lonnerdal B. Molecular cloning and functional expression of a human intestinal lactoferrin receptor. Biochemistry. 2001 Dec 25;40(51):15771-9. doi: 10.1021/bi0155899.
Shin K, Wakabayashi H, Yamauchi K, Yaeshima T, Iwatsuki K. Recombinant human intelectin binds bovine lactoferrin and its peptides. Biol Pharm Bull. 2008 Aug;31(8):1605-8. doi: 10.1248/bpb.31.1605.
Berlutti F, Schippa S, Morea C, Sarli S, Perfetto B, Donnarumma G, Valenti P. Lactoferrin downregulates pro-inflammatory cytokines upexpressed in intestinal epithelial cells infected with invasive or noninvasive Escherichia coli strains. Biochem Cell Biol. 2006 Jun;84(3):351-7. doi: 10.1139/o06-039.
Griffin IJ. The Effects of Different Forms of Lactoferrin on Iron Absorption. J Nutr. 2020 Dec 10;150(12):3053-3054. doi: 10.1093/jn/nxaa314. No abstract available.
Kell DB, Heyden EL, Pretorius E. The Biology of Lactoferrin, an Iron-Binding Protein That Can Help Defend Against Viruses and Bacteria. Front Immunol. 2020 May 28;11:1221. doi: 10.3389/fimmu.2020.01221. eCollection 2020.
First Posted
January 31, 2024
Study Start
March 1, 2024
Actual (reported)Primary Completion
May 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 28, 2025
Record last verified: 2024-04
Any de-identified collected data through RedCap and wet-lab assays will be made available upon publication.
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Source: ClinicalTrials.gov.
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