Effects of rhLactoferrin on Chronic Inflammation in the Elderly (ELCIE)
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About
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).
Full description
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
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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
Exclusion criteria
- 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) < 21.
- Lactose intolerant
- allergy or intolerance to bovine products
- being a vegan (since vegans will want to avoid Bovine products.
Trial design
Primary purpose
Allocation
Interventional model
Masking
36 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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