Effects of rhLactoferrin on Chronic Inflammation in the Elderly
| Status: | Recruiting |
|---|---|
| Conditions: | Cognitive Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 70 - Any |
| Updated: | 4/17/2018 |
| Start Date: | August 14, 2017 |
| End Date: | February 2019 |
| Contact: | Jeremy D. Walston, MD |
| Email: | jwalston@jhmi.edu |
| Phone: | 410-550-1003 |
Effects of Lactoferrin on Chronic Inflammation in the Elderly
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).
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).
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 datad will
complement mobility measures by describing function enacted in daily life
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 datad will
complement mobility measures by describing function enacted in daily life
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.
We found this trial at
1
site
Baltimore, Maryland 21224
Principal Investigator: Jeremy D. Walston, MD
Phone: 410-550-2113
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