The Effects of Lactoferrin and Iron-enriched Whey on Iron Status of Active Collegiate Females
The Effects of Lactoferrin and Iron-enriched Whey on Iron Status of Active Collegiate Females
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).
BACKGROUND AND SIGNIFICANCE
Iron deficiency is a major cause of disease burden worldwide, affecting 1-2 billion people globally. While often considered an issue in developing nations, low iron intake is a growing problem in the US and other industrialized nations, particularly affecting women of reproductive age. In the US, 20% of women aged 18-45 have insufficient iron intake (below the EAR of 18 mg/day) and this number that has been growing over the last decades. This is, in part, due to reduced concentrations in foods and lower intakes of iron-containing foods. Moreover, iron-rich food sources also contain vitamin B12, which is an important co-factor in iron metabolism.
There is, therefore, a strong need to develop strategies that can improve iron status in women of reproductive age, given the generally low intakes of iron-containing sources in this demographic. Besides increasing iron intake, a promising strategy to improve iron status is to ingest compounds that can promote iron uptake. A particularly promising compound to increase iron uptake is lactoferrin.
Lactoferrin (LF) is an iron-binding glycoprotein enriched in mammalian milk. LF binds iron with exceptionally high affinity and is transferred via a variety of receptors into and between cells, serum, bile, and cerebrospinal fluid. It also has important immunological properties, particularly being anti-inflammatory and anti-viral.
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 at heightened risk for iron-deficiency anemia, found that the combined supplementation of lactoferrin and iron was able to maintain serum ferritin (an indicator of iron status) and red blood cell counts, whereas supplementation with iron alone did not maintain serum ferritin levels and red blood cell counts during the 8-week training period.
To ensure proper absorption, LF is best ingested in a dairy matrix. That is because of the presence of an LF receptor in the human small intestine that can bind bovine LF, likely preventing the use of iron by gut pathogens. This, in turn, results in enhanced systemic availability of iron where it can exert beneficial tissue effects and contribute to adequate iron status.
There is also evidence from in vitro work to suggest that lactoferrin can have anti-inflammatory properties, which could further improve serum iron and hemoglobin concentrations as inflammation negatively impacts iron metabolism. However, more clinical nutrition work is certainly needed to study these potential beneficial effects of LF.
2. STUDY OBJECTIVES
3. DESIGN AND PROCEDURES
3.1 Study duration Participant involvement will be 17 weeks. Week one, participants will go through the initial screening process. participants will consume two servings of supplement per day for the remaining 16 weeks.
3.2 Participants We will recruit 90 physically active female participants between 18-30 yrs, who are physically active (>2 days/week) with a BMI ≥18 and ≤30 kg/m2.
3.3 Description of study visits
Pre-screening (week 1. 15 minutes): Interested participants will have access to the informed consent via a link to recruitment materials. Participants that reach out via email or phone will be provided with a REDCap survey link to the screening questions that asks them further details about their health, diet, and sleep (see inclusion/exclusion criteria). Only minimum personal health information will be collected to determine eligibility. Responses will be reviewed by a study team member (all study team members will have completed the necessary CITI training) and potentially eligible candidates will be contacted to schedule a consent/screening visit. The pre-screen is to confirm that the participant meets most of the criteria before the subject is scheduled for a consent meeting. This will limit subject and research staff time burden. Information gathered will not be attached to identifiers and will be deleted if they decide to not participate or do not meet criteria. If participants screen as a "maybe", they will be contacted by phone or email with follow up questions to determine eligibility. Participants who are taking some medications that may interfere, but who are willing to stop cease usage will require a doctor's release to stop taking prescription medications.
Consent (Week 1. Duration: 1 hour): This visit will take place at the Center for Human Nutrition Studies or will happen virtually (via a tele-call platform such as Zoom). This visit will include the following. Participants will review the consent document with a member of the study team; once all questions have been satisfactorily answered, participants will be asked to sign and date the consent form if participants wish to participate in the study. Participants will be asked to sign the consent form electronically through REDCap using a unique link that is provided to them.
When deemed eligible and contacted, participants can combine the consent visit with the screening visit described below. If participants wish to do so, participants will be asked to come to the Center for Human Nutrition Studies in the morning after an overnight fast, requiring them not to eat or chew gum (nothing but water) 12 hours prior to their arrival. This information will not apply if the investigators do a virtual consent visit first. If participants agree to participate, they will come for the in-person screening visit.
Initial Screening Visit (Week 1. Duration: 1 hour): Assuming participants pre-qualify for the study, and are interested in participating, they will undergo an in-person screening visit. This visit will take place at the Center for Human Nutrition Studies. This visit will be performed in the morning, will last approximately 1 hour, and requires participants not to eat anything or chew gum (nothing but water) for 12 hours prior to their arrival time. This visit will include the following:
Intervention Assignment and Intervention (Week 2 - 17. Duration: 10 min per week): If participants meet the inclusion criteria, participants will be randomly assigned to one of three groups for the duration of the study. The group assignment is random (like the flip of a coin) and participants will not know which group participants are in.
Mid intervention check-in (Week 9. Duration: 1 hour):
• Questionnaires: 7-day food log The questionnaire will include a 7-day recall of food consumed over the last week including what foods, how much and at about what time.
Final visit (Week 17. Duration: 1 hour): This visit will take place at the Center for Human Nutrition Studies. This visit will be performed in the morning, will last approximately 1 hour, and requires participants not to eat anything or chew gum (nothing but water) for 12 hours prior to their arrival time. This visit will include the following:
Inclusion Criteria:
Exclusion Criteria: