Lactoferrin-Enriched Whey for Iron-Deficiency Anemia

Overseen By Connor J kemp, BS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Utah State University

Must not be taking: NSAIDs, Corticosteroids, Anticoagulants, others

Disqualifiers: Pregnancy, Diabetes, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 16 weeks

82 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Do I have to stop taking my current medications?

You may need to stop taking certain medications or supplements that affect the study outcomes, like NSAIDs, corticosteroids, or iron supplements, if they can't be temporarily discontinued for the study.

Will I have to stop taking my current medications?

If you are taking medications or supplements that affect the study's outcome measures, like NSAIDs, corticosteroids, or iron supplements, you may need to stop them temporarily for this study.

What data supports the idea that Lactoferrin-Enriched Whey for Iron-Deficiency Anemia is an effective treatment?

The available research shows that Lactoferrin-Enriched Whey can be an effective treatment for iron-deficiency anemia. In studies with mice, supplementing with lactoferrin-bound iron prevented anemia and maintained healthy iron levels in tissues, similar to traditional iron supplements. Additionally, a review comparing lactoferrin to ferrous sulfate, a common iron supplement, found that lactoferrin had better effects on increasing iron levels in the blood and caused fewer stomach-related side effects. This suggests that lactoferrin is not only effective but also gentler on the stomach compared to some other iron supplements. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Lactoferrin-Enriched Whey for Iron-Deficiency Anemia?

Research shows that lactoferrin, an iron-binding protein found in milk, can effectively prevent anemia and improve iron levels in the body, similar to traditional iron supplements, but with fewer side effects. This suggests that lactoferrin-enriched treatments could be beneficial for managing iron-deficiency anemia. ^{1 2 3 4 5}

What safety data exists for Lactoferrin-Enriched Whey for Iron-Deficiency Anemia?

The safety data for lactoferrin-enriched treatments, including those combined with iron and vitamin B12, suggest that lactoferrin is generally well-tolerated with fewer gastrointestinal side effects compared to traditional iron supplements like ferrous sulfate. Studies have shown that lactoferrin can effectively improve iron status without negative effects on iron metabolism. Animal studies have also indicated no significant adverse effects when lactoferrin is used as an iron supplement. Overall, lactoferrin appears to be a safe option for addressing iron-deficiency anemia. ^{1 4 6 7 8}

Is lactoferrin-enriched whey safe for humans?

Lactoferrin, a milk-derived protein, is generally well-tolerated and has fewer gastrointestinal side effects compared to traditional iron supplements like ferrous sulfate. Studies in pregnant women and other trials suggest it is safe for human use, with no significant negative effects reported. ^{1 4 6 7 8}

Is the treatment Lactoferrin, Iron, and B12 in Whey Protein a promising treatment for iron-deficiency anemia?

Yes, the treatment is promising. Lactoferrin, an iron-binding protein found in milk, helps improve iron levels and reduce anemia. It is well-tolerated and has fewer side effects compared to traditional iron supplements. Studies show it effectively increases iron in the body, making it a beneficial option for treating iron-deficiency anemia. ^{1 2 3 4 9}

How is the treatment Lactoferrin-Enriched Whey for Iron-Deficiency Anemia different from other treatments?

This treatment is unique because it uses lactoferrin, a protein found in milk that binds iron, which may improve iron absorption with fewer gastrointestinal side effects compared to traditional iron supplements like ferrous sulfate. ^{1 2 3 4 9}

Eligibility Criteria

This trial is for active young women aged 18-30 with a BMI of 18-30 kg/m2 who are experiencing iron-deficiency anemia. Participants should exercise regularly, speak and understand English, and be able to give informed consent. It's not suitable for those outside these criteria.

Inclusion Criteria

I am female.

My Body Mass Index (BMI) is between 18 and 30.

For my safety and proper consent, I am...

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person or virtual)

Treatment

Participants consume assigned supplements twice daily for 16 weeks

16 weeks

Weekly visits for supplement pickup and questionnaire completion

Mid-intervention Check-in

Participants complete a 7-day food log and other questionnaires

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Lactoferrin, Iron and B12 in Maltodextrin
• Lactoferrin, Iron and B12 in Rice Protein
• Lactoferrin, iron and B12 in Whey Protein

Trial Overview The study tests the effects of drinks enriched with lactoferrin (200 mg), iron (6 mg), and vitamin B12 (5.2 µg) on iron metabolism and inflammation in females when consumed twice daily over 16 weeks. The drinks are based on whey protein, rice protein, or maltodextrin.

Participant Groups

Group I: Lactoferrin in Whey Protein Active Control 1 Intervention

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.

Group II: Lactoferrin in Rice Protein Active Control 1 Intervention

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.

Group III: Lactoferrin Control Active Control 1 Intervention

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.

Lactoferrin, Iron and B12 in Maltodextrin is already approved in United States, European Union for the following indications:

Approved in United States as Lactoferrin, Iron and Vitamin B12 Supplement for:

• Iron deficiency anemia
• Inflammation reduction

Approved in European Union as Lactoferrin, Iron and Vitamin B12 Supplement for:

• Iron deficiency anemia
• Inflammation reduction

Who Is Running the Clinical Trial?

Utah State University

Lead Sponsor

Trials

48

Recruited

5,200+

BUILD Dairy

Collaborator

Trials

2

Recruited

100+

Glanbia Nutritionals

Industry Sponsor

Trials

1

Recruited

80+

Findings from Research

Supplementing iron bound to lactoferrin effectively prevents anemia in young mice, showing similar efficacy to traditional iron chloride supplementation, even after a 4-week diet low in iron.

Lactoferrin appears to be a safe and effective vehicle for iron supplementation, as it did not negatively impact the iron status of the mice, making it a promising option for addressing iron deficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplementation of milk with iron bound to lactoferrin using weanling mice: L. Effects on hematology and tissue iron. Fransson, GB., Keen, CL., Lönnerdal, B.[2019]

Lactoferrin, an important protein found in milk, has beneficial effects for both newborns and adults, leading to interest in its use as a nutritional supplement.

Human lactoferrin can be produced from various sources like yeast, transgenic cows, and rice, with the latter two being suitable for food applications, although they are still awaiting regulatory approval.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant human lactoferrin: a valuable protein for pharmaceutical products and functional foods. Conesa, C., Calvo, M., Sánchez, L.[2022]

In a study involving 260 infants aged 4 to 6 months, those fed an iron-fortified formula with lactoferrin showed significantly improved hematologic indexes, including higher hemoglobin levels and total body iron content, compared to those on a standard iron-fortified formula without lactoferrin.

The lactoferrin-fortified group also had a lower prevalence of anemia and iron deficiency, indicating that lactoferrin enhances iron absorption and overall iron status in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iron metabolism in infants: influence of bovine lactoferrin from iron-fortified formula. Ke, C., Lan, Z., Hua, L., et al.[2015]

Lactoferrin supplementation significantly improved serum iron levels, ferritin, and hemoglobin concentration compared to ferrous sulfate, indicating its superior efficacy in managing iron-deficiency anemia.

The study suggests that lactoferrin's effectiveness may be linked to its anti-inflammatory properties rather than its influence on iron absorption, as it showed a reduction in fractional iron absorption compared to ferrous sulfate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effects between Oral Lactoferrin and Ferrous Sulfate Supplementation on Iron-Deficiency Anemia: A Comprehensive Review and Meta-Analysis of Clinical Trials. Zhao, X., Zhang, X., Xu, T., et al.[2023]

Supplementation with bovine lactoferrin (bLf) in iron-fortified formulas significantly reduced the incidence of respiratory tract infections and diarrhea in weaned infants, as shown in a study of 260 infants over 3 months.

Infants receiving lactoferrin-fortified formula experienced fewer respiratory symptoms and diarrhea-related illnesses compared to those on non-fortified formula, suggesting that bLf may enhance immune function in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of bovine lactoferrin from iron-fortified formulas on diarrhea and respiratory tract infections of weaned infants in a randomized controlled trial. Chen, K., Chai, L., Li, H., et al.[2016]

In a study involving lactating Wistar rats, the absorption and bioavailability of iron from 57Fe-Lf (apo-lactoferrin) and 57FeSO4 were compared, revealing that the type of iron and dosage significantly influenced iron distribution in the body.

The findings suggest that using iron salts in excess of lactoferrin is the most effective method for iron supplementation in formula milk, as it optimizes iron transport and storage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iron bioavailability from supplemented formula milk: effect of lactoferrin addition. Fernández-Menéndez, S., Fernández-Sánchez, ML., González-Iglesias, H., et al.[2018]

In a study involving 100 weanling SD rats over 28 days, recombinant human lactoferrin (rhLF) showed no significant differences in food safety indicators compared to bovine lactoferrin (bLF), indicating that both are safe for consumption.

Both rhLF and bLF groups demonstrated improved serum iron levels and transferrin saturation compared to the control group, suggesting that these lactoferrins can enhance iron nutrition without adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Animal experiment of recombinant human lactoferrin based on the 28 days repeated oral toxicity]. Ma, B., Yuan, X., Wang, X., et al.[2019]

In a study involving 100 pregnant women with iron deficiency anemia, both bovine lactoferrin and ferrous sulfate effectively increased hemoglobin and iron levels after 30 days of treatment, showing similar efficacy.

Bovine lactoferrin was associated with significantly fewer gastrointestinal side effects, such as abdominal pain and constipation, compared to ferrous sulfate, making it a potentially safer option for treating iron deficiency in pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of oral bovine lactoferrin compared to ferrous sulfate in pregnant women with iron deficiency anemia: a prospective controlled randomized study. Nappi, C., Tommaselli, GA., Morra, I., et al.[2014]

In a study involving SD rats with iron deficiency anemia, treatment with iron saturated recombinant human lactoferrin (Fe-rhLf) significantly improved hemoglobin levels and red blood cell counts compared to the control group, indicating its efficacy in treating this condition.

The high dose of Fe-rhLf not only enhanced hematological parameters but also altered liver hepcidin and ferroportin expression, suggesting a mechanism of action that may involve regulation of iron metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of iron saturated recombinant human lactoferrin on alleviating iron deficiency anemia in rats]. Fang, YH., Feng, X., Xu, H., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Supplementation of milk with iron bound to lactoferrin using weanling mice: L. Effects on hematology and tissue iron. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Recombinant human lactoferrin: a valuable protein for pharmaceutical products and functional foods. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Iron metabolism in infants: influence of bovine lactoferrin from iron-fortified formula. [2015]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Comparative Effects between Oral Lactoferrin and Ferrous Sulfate Supplementation on Iron-Deficiency Anemia: A Comprehensive Review and Meta-Analysis of Clinical Trials. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of bovine lactoferrin from iron-fortified formulas on diarrhea and respiratory tract infections of weaned infants in a randomized controlled trial. [2016]

6. Germany pubmed.ncbi.nlm.nih.gov

Iron bioavailability from supplemented formula milk: effect of lactoferrin addition. [2018]

7. China pubmed.ncbi.nlm.nih.gov

[Animal experiment of recombinant human lactoferrin based on the 28 days repeated oral toxicity]. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of oral bovine lactoferrin compared to ferrous sulfate in pregnant women with iron deficiency anemia: a prospective controlled randomized study. [2014]

9. China pubmed.ncbi.nlm.nih.gov

[Efficacy of iron saturated recombinant human lactoferrin on alleviating iron deficiency anemia in rats]. [2019]