Clinical trial NCT02968992: Effects of rhLactoferrin on Chronic Inflammation in the Elderly
Official title: Effects of Lactoferrin on Chronic Inflammation in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inflammation
Cognitive Deterioration
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Ventria Bioscience
name: National Institute on Aging (NIA)
First posted: 2016-11-21
Enrollment: 36
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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

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.

Primary outcomes:
measure: The Effect of Rhlactoferrin on Serum Levels of Interleukin-6 (IL-6)
timeFrame: Baseline and 6 months
measure: The Effect of Rhlactoferrin on Serum Levels of Tumor Necrosis Factor Alpha Receptor 1 (TNFR1)
timeFrame: From baseline to 6 months
Secondary outcomes:
measure: Attenuating Cognitive Decline as Measured by the Digital Symbol Substitution Test
timeFrame: At 6 months
measure: Attenuating Cognitive Decline as Measured by the Trail Making Test A and B.
timeFrame: At 6 months
measure: Physical Mobility as Measured by 4 Meter Walk Test
timeFrame: At 6 months
measure: Physical Mobility as Measured by 6 Minute Walk Test
timeFrame: At 6 months
measure: Tolerability of Oral rhLactoferrin as Assessed by Patient Diary of Total Number of Side Effects
timeFrame: From baseline through 6 months.
measure: Physical Strength as Measured by Grip Strength
timeFrame: At 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Jeremy D. Walston
state: Maryland
Study officials:
affiliation: Johns Hopkins Universtiy
name: Jerermy D. Walston, MD
role: PRINCIPAL_INVESTIGATOR
References: