Effects of Lactoferrin on Chronic Inflammation in the Elderly
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The Effect of Rhlactoferrin on Serum Levels of Interleukin-6 (IL-6)
研究概览
简要总结
The purpose of this study is to investigate how recombinant human lactoferrin (rhLF) which is a partially iron saturated form of lactoferrin produced and purified from rice grain may improve mobility and memory in older adults with chronic inflammation. Lactoferrin, is a known multifunctional protein, and has been shown to have anti-inflammatory effects. A recombinant human version of this protein was recently developed and produced from rice. This is now available from the Ventria Bioscience Company in a controlled, pharmaceutical grade capsule. As part of this double blinded and randomized study, participants will take daily dosages of recombinant human lactoferrin (rhLF) or its matched placebo; to measure the effects of rhlactoferrin on chronic inflammation and its association with improving mobility and memory over a 6 month time period. During the study all participants will be asked to provide blood samples and will have physical and cognitive tests administered to them. By measuring biomarkers in the blood as well as changes in physical and cognitive measures, the investigators will gain an understanding of how rhlactoferrin may safely improve measures of chronic inflammation in older adults. As well as a better understanding of whether it has the potential to meaningfully influence important measures of physical and cognitive function known to be influenced by Chronic Inflammation (CI).
详细描述
The primary objective of this study is to examine in a double blinded and randomized trial the efficacy of Recombinant Human lactoferrin (rhLF) in reducing chronic inflammation as measured by IL-6 and sTNFR1 in the bloodstream. The primary end point is to gather information about the tolerability of and adherence to oral rhlactoferrin (rhLF) among older adults with CI over a six-month period. The exploratory objective is to assess the efficacy of rhlactoferrin (rhLF) in attenuating cognitive decline as measured by the Digit Symbol Substitution Test and Trail Making Test, as well as improving physical mobility as measured by performance on 4 meter and six-minute walk tests. Further physical and functional measurement data will be gather using an Acti-graph link Activity monitor, the raw data collected will be used to : (i) characterize cumulative daily activity, (ii) assess daily circadian patterns of activity, (iii) assess physical activity variability, (iv) model patterns of daily activity, and (iv) estimate walking speed. This additional data will complement mobility measures by describing function enacted in daily life
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
•Randomized: Participants are assigned to intervention groups by chance
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 70 and older
- •able to complete 4- meter timed walk; walking speed <1.0 m/sec
- •serum IL-6 level ≥ 2.5 pg/ml or TNFR1 level ≥1500 pg/ml
排除标准
- •Daily anti-inflammatory drug use (prednisone, Advil, Aleve, Remicade, Enbrel, methotrexate, standing nonsteroidal anti-inflammatory drugs (NSAID), aspirin greater than 325 mg per day)
- •lower extremity mobility disability caused by Parkinson's disease,
- •cerebral vascular accident (CVA) with residual motor deficit,
- •severe osteoarthritis or rheumatoid arthritis
- •symptomatic claudication
- •hospitalization within 3 months for myocardial infarction (MI), angina, infection requiring antibiotics, or joint replacement.
- •Mini-Mental State Examination (MMSE) <
- •Lactose intolerant
- •allergy or intolerance to bovine products
- •being a vegan (since vegans will want to avoid Bovine products.
研究组 & 干预措施
rhLactoferrin
rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.
干预措施: rhLactoferrin (Drug)
Placebo
Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.
干预措施: Placebo (Other)
结局指标
主要结局
The Effect of Rhlactoferrin on Serum Levels of Interleukin-6 (IL-6)
时间窗: Baseline and 6 months
The effect of rhlactoferrin on serum levels (picogram/milliliter) of Interleukin-6 (IL-6) will be assessed as a measure of the percentage change of IL-6 serum levels from baseline
The Effect of Rhlactoferrin on Serum Levels of Tumor Necrosis Factor Alpha Receptor 1 (TNFR1)
时间窗: From baseline to 6 months
The effect of rhlactoferrin on serum levels (picogram/milliliter) of tumor necrosis factor alpha receptor 1 (TNFR1) assessed as a measure of the percentage change of serum TNFR1 levels from baseline
次要结局
- Physical Mobility as Measured by 4 Meter Walk Test(At 6 months)
- Tolerability of Oral rhLactoferrin as Assessed by Patient Diary of Total Number of Side Effects(From baseline through 6 months.)
- Attenuating Cognitive Decline as Measured by the Digital Symbol Substitution Test(At 6 months)
- Physical Strength as Measured by Grip Strength(At 6 months)
- Attenuating Cognitive Decline as Measured by the Trail Making Test A and B.(At 6 months)
- Physical Mobility as Measured by 6 Minute Walk Test(At 6 months)