The Effects of Lactoferrin and Iron-enriched Whey on Iron Status of Active Collegiate Females
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Serum Ferritin
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Supplement arms will be marked with a random number code assigned by a non-participating researcher immediately after supplements are prepared. Supplements will be provided to participants in unmarked sachets.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Biological sex: Female
- •Age ≥18 and ≤30 years;
- •BMI ≥18 and ≤30 kg/m2;
- •For the safety of the participant and proper consent of the procedures, subjects
- •must be able to speak and understand English to participate in this study,
- •which will be determined at the discretion of study staff;
- •Actively engaged in exercise/training ≥3 and ≤12 times per week with each session being from ≥30min to ≤3 hours in length of moderate to vigorous activity. activities that meet this criterion may include but are not limited to: hiking, weightlifting, volleyball, basketball, soccer, or others sport or activities' that involves strenuous physical activity
排除标准
- •Use of medications or supplements that are known to affect the study outcome measures (e.g., NSAIDs, corticosteroids, iron containing supplements) or increase the risk of study procedures (e.g., anticoagulants) that cannot be temporarily discontinued for this study.
- •Allergy to rice and/or whey protein.
- •Pregnant or lactating.
- •>7 meals/week containing red meat and/or shellfish (iron-rich foods).
- •Hb1Ac >6.4%
- •Consuming >14 alcoholic drinks per week;
- •Use of cigarettes (or other tobacco products) in last 3 months;
- •Diagnoses of active malignancy, congestive heart failure, diabetes mellitus or chronic obstructive pulmonary disease;
- •Any inflammatory diseases (e.g., autoimmune diseases, coeliac disease, glomerulonephritis, hepatitis, inflammatory bowel disease, arthritis).
- •Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits
结局指标
主要结局
Serum Ferritin
时间窗: Tested at week 0 before supplementation begins, and week 16 after the final supplements have been taken.
Free Serum Ferritin measured via enzymatic detection at LabCorp Inc. as proxy of iron absorption.
次要结局
- 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.)
- 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.)
- 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.)
- Marker of Iron metabolism Hemoglobin(Tested on week 1 before supplementation begins, and week 16 after the final supplements have been taken.)