Effects of rhLactoferrin on Chronic Inflammation in the Elderly
Condition: Inflammation; Cognitive Deterioration
MeSH terms: Inflammation
Intervention: rhLactoferrin; Placebo
Intervention description: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.; Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: •Randomized: Participants are assigned to intervention groups by chance
Enrollment: 36.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No

Summary:

      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).
    

Eligibility criteria:

        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.