Lactoferrin for Iron Deficiency in Exercising Women
(EFF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether lactoferrin, a natural protein, can improve iron levels and boost performance in women who exercise regularly and have low iron stores. Participants will receive either a low or high dose of lactoferrin combined with a small amount of iron, or a placebo with iron, while researchers monitor their fitness and iron levels over eight weeks. The trial aims to determine if lactoferrin can enhance iron balance and athletic performance. Women who frequently exercise and have low iron levels, particularly those in endurance events, might be ideal candidates for this study. As an unphased trial, this study provides a unique opportunity to explore lactoferrin's potential benefits for enhancing athletic performance and iron balance.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you must not start any new vitamins, minerals, or dietary supplements during the study and avoid taking them 24 hours before study visits. If you are on psychiatric medication, your regimen must be stable for at least 3 months with no changes expected during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study demonstrated that bovine lactoferrin (from cows) is a safe addition to human diets, making it popular for those seeking to improve iron levels. Research has shown that human lactoferrin, like the one used in this trial, is gentle on the stomach and avoids the issues often associated with other iron supplements. Another study found that lactoferrin can boost iron levels without the side effects of traditional iron pills. Overall, lactoferrin is considered a safe option for increasing iron, making it promising for individuals with low iron levels.12345
Why are researchers excited about this trial's treatments?
Most treatments for iron deficiency in exercising women involve oral iron supplements, which can sometimes cause digestive issues. Unlike these standard treatments, lactoferrin is a protein that helps the body absorb iron more efficiently. Researchers are excited because lactoferrin may also have anti-inflammatory and immune-boosting benefits, potentially offering a more holistic approach to managing iron deficiency. The trial is testing two dosages: a low-dose and a high-dose lactoferrin, to determine the most effective amount for improving iron levels without side effects.
What evidence suggests that lactoferrin might be an effective treatment for iron deficiency in exercising women?
Research has shown that combining lactoferrin with iron improves iron levels more effectively than taking iron alone. One study found that adding lactoferrin increased iron storage in the blood by 3.52 µg/L compared to taking iron alone. Other studies have demonstrated that lactoferrin enhances overall iron levels, including hemoglobin and total iron in the blood. In this trial, participants will receive either a low-dose or high-dose of lactoferrin combined with iron, or a placebo with iron. In female athletes, lactoferrin has shown promise in preventing anemia and enhancing performance. These findings suggest that lactoferrin could improve iron levels and athletic performance in women with low iron.46789
Who Is on the Research Team?
Chad M Kerksick, PhD
Principal Investigator
Lindenwood University
Are You a Good Fit for This Trial?
This trial is for healthy women aged 18-45 who regularly exercise (at least 5 hours/week), have regular periods, low iron stores (ferritin <30 µg/L), and are training for or participating in endurance events. They must not have recent infections, chronic illnesses, digestive issues, or major psychiatric conditions.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily supplementation of lactoferrin and iron or placebo for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lactoferrin
Trial Overview
The study tests if taking lactoferrin (100 mg or 300 mg) plus a small amount of iron daily improves iron levels and exercise performance compared to just low-dose iron. Participants are randomly assigned to one of three groups for eight weeks without knowing which group they're in.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Participants will consume 100 mg human lactoferrin (effera®) combined with 5 mg iron daily for 8 weeks.
Participants will consume 300 mg human lactoferrin (effera®) combined with 5 mg iron daily for 8 weeks.
Participants will consume a placebo combined with 5 mg iron daily for 8 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lindenwood University
Lead Sponsor
Citations
Is Iron Combined With Lactoferrin More Effective Than ...
Overall, LF supplementation showed an additional effect on serum ferritin compared with iron alone (MD, 3.52 µg/L; 95% CI, 0.66-6.38; P = .02).
Lactoferrin for Iron Deficiency in Exercising Women
Approximately 30 healthy, menstruating women aged 18-45 years with serum ferritin \<35 µg/L will be enrolled in an 8-week intervention.
The Effects of Lactoferrin and Iron-Enriched Whey on Iron ...
Among athletes, adequate iron status is critical to performance but nearly half of female athletes show signs of iron deficiency. While iron supplementation ...
Improving Iron Status Without Iron: Clinical Insights From ...
Several clinical studies have reported improvements in iron biomarkers, including ferritin and hemoglobin, following LF supplementation in ...
Effects of Lactoferrin-enriched Whey on Iron Status in ...
LF supplementation has shown initial promise for enhancing iron status in women of reproductive age. A previous study on female long-distance runners, a group ...
The effectiveness of oral bovine lactoferrin compared to iron ...
In all 19 randomized trials included in this study, bLF has been suggested as an effective and safe alternative to iron supplementation by the ...
Lactoferrin for Prevention and Treatment of Anemia and ... - PMC
Bovine lactoferrin (BLTF) is readily available on the nutritional market and generally recognized as safe (GRAS) for use in human diet. Keywords: lactoferrin, ...
Lactoferrin or ferrous salts for iron deficiency anemia in ...
Unlike ferrous sulphate, lactoferrin was superior in that it did not provoke adverse gastrointestinal side effects [13]. To our knowledge, there has been no ...
Lactoferrin for Treatment of Iron Deficiency Anemia.
Many studies showed that oral bovine lactoferrin for pregnant women increased levels of hemoglobin, total serum iron, and ferritin and decreased ...
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