Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Change in serum iron (mcg/dL)
研究概览
简要总结
Overall Objective: To determine the efficacy of rbLf supplementation in a healthy adult population, specifically with regard to iron regulation (primary), gut health (secondary), and immune function (secondary). Purpose: The purpose of this study is to determine the effects of rbLf on iron regulation, exercise performance, gut health, and immune function as compared to cow's milk derived bLf.
Participants: To account for an approximate ~10% dropout rate (and rounding up to ensure equal number of enrolled participants per group), n=25 per group for males (N=50) and n=30 per group for females (N=60) will be enrolled for a total sample size of N=110.
Procedures: Participation in this study will include 6 in-person visits over 14 weeks. Anemia will be checked and excluded at the first visit using a single finger prick, followed by a 10-20 min exercise test on a treadmill to evaluate exercise capacity. On visit 2 participants will perform three 3-15 minute exercise tests on a treadmill with rest in between each test in order to determine exercise performance. A finger prick will be performed before and after each run to determine lactate levels. After visits 2 participants will be randomized to their respective supplement group recombinant Bovine Lactoferrin supplement (rbLf) (Male and Fame), a bovine-milk derived Lactoferrin supplement (Female), or a placebo (Male) once daily for 4 weeks. Blood samples will be obtained prior to and after each supplement phase to determine change in iron levels and red blood cell capacity. After a 2-week washout participants will return to complete the same testing outcomes and will receive the subsequent supplement. At visit 6 a final blood sample will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-42 years
- •Body mass index less than 35 kg/m^2
- •Finger prick hemoglobin levels fitting within "normal range"
- •Males: 14-18g/dL
- •Females: 12-16g/dL
- •Active: meeting American College of Sports Medicine exercise guidelines or exercising more than 2 days per week of
- •● For females specifically:
- •Pre-menopausal: experiencing a regular period with no signs of perimenopause or menopause.
排除标准
- •Clinically diagnosed iron-deficiency anemia, pagophagia, hemochromatosis, or other blood or iron related medical conditions.
- •Allergy or intolerance to milk, egg, soy, peanut, wheat, coconut, or almond dairy
- •Smokers or vapers of nicotine or nicotine products
- •Immunocompromised or diagnosed with Type I or II diabetes
- •Irritable Bowel Disease, Crohn's disease, Celiacs
- •Bowel movements less than three times per week, or clinically constipated
- •Oral contraceptive users that have combined iron supplementation, or non-monophasic oral contraceptive users.
- •Pregnant or nursing
- •Chronic eczema or clinically diagnosed asthma.
- •Current antibiotic use or antibiotic use within the past 6 weeks
- •If flu, corona virus, or cold occurs, subject will remain in the study with their original scheduled visits, but immune values will be excluded.
- •Vegan (due to supplement ingredients).
研究组 & 干预措施
Females: Recombinant Bovine Lactoferrin (rbLf), then Bovine milk derived Lactoferrin
After a 2-week run-in period, this arm will begin treatment with recombinant bovine lactoferrin for 4 weeks and following a 2-week washout start bovine milk derived lactoferrin for 4 weeks.
干预措施: Recombinant Bovine Lactoferrin (Dietary Supplement)
Females: Recombinant Bovine Lactoferrin (rbLf), then Bovine milk derived Lactoferrin
After a 2-week run-in period, this arm will begin treatment with recombinant bovine lactoferrin for 4 weeks and following a 2-week washout start bovine milk derived lactoferrin for 4 weeks.
干预措施: Bovine Milk-Derived Lactoferrin (Dietary Supplement)
Females: Bovine milk derived lactoferrin (cmdLf), then Recombinant bovine lactoferrin
After a 2-week run-in period, this arm will begin treatment with bovine milk derived lactoferrin and then following a 2-week washout start recombinant bovine lactoferrin for 4 weeks.
干预措施: Recombinant Bovine Lactoferrin (Dietary Supplement)
Females: Bovine milk derived lactoferrin (cmdLf), then Recombinant bovine lactoferrin
After a 2-week run-in period, this arm will begin treatment with bovine milk derived lactoferrin and then following a 2-week washout start recombinant bovine lactoferrin for 4 weeks.
干预措施: Bovine Milk-Derived Lactoferrin (Dietary Supplement)
Males: Recombinant Bovine Lactoferrin (rbLf), then placebo
After a 2-week run-in period, this arm will begin treatment with recombinant bovine lactoferrin for 4 weeks and following a 2-week washout start placebo for 4 weeks.
干预措施: Recombinant Bovine Lactoferrin (Dietary Supplement)
Males: Recombinant Bovine Lactoferrin (rbLf), then placebo
After a 2-week run-in period, this arm will begin treatment with recombinant bovine lactoferrin for 4 weeks and following a 2-week washout start placebo for 4 weeks.
干预措施: Placebo (Dietary Supplement)
Males: Placebo, then recombinant bovine lactoferrin (rbLf)
After a 2-week run-in period, this arm will begin treatment with placebo for 4 weeks and following a 2-week washout start recombinant bovine lactoferrin for 4 weeks.
干预措施: Recombinant Bovine Lactoferrin (Dietary Supplement)
Males: Placebo, then recombinant bovine lactoferrin (rbLf)
After a 2-week run-in period, this arm will begin treatment with placebo for 4 weeks and following a 2-week washout start recombinant bovine lactoferrin for 4 weeks.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in serum iron (mcg/dL)
时间窗: baseline to 4 weeks
change in serum blood values obtained before and after supplementation
Change in red blood cell count (trillion cells/L)
时间窗: baseline to 4 weeks
change in blood values obtained before and after supplementation
Change in ferritin iron (ng/mL)
时间窗: baseline to 4 weeks
change in blood values obtained before and after supplementation
change in iron binding capacity (mcg/dL)
时间窗: baseline to 4 weeks
change in blood values obtained before and after supplementation
次要结局
- change in interleukin-6 (pg/ml)(baseline to 4 weeks)
- change on tumor necrosis factor-a (pg/mL)(baseline to 4 weeks)
- change in time to exhaustion running (seconds)(baseline to 4 weeks)