Phase 2
N=36
Effects of rhLactoferrin on Chronic Inflammation in the Elderly
Inflammation · Cognitive Deterioration
Bottom Line
View on ClinicalTrials.gov: NCT02968992 ↗Enrolled (actual)
36
Serious AEs
2.8%
Results posted
Mar 2020
Primary outcome: Primary: The Effect of Rhlactoferrin on Serum Levels of Interleukin-6 (IL-6) — -0.640; 0.932 Percent change of IL-6
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rhLactoferrin (Drug); Placebo (Other)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Effect of Rhlactoferrin on Serum Levels of Interleukin-6 (IL-6) |
-0.640; 0.932 | — |
| PRIMARY The Effect of Rhlactoferrin on Serum Levels of Tumor Necrosis Factor Alpha Receptor 1 (TNFR1) |
19.709; 140.748 | — |
| SECONDARY Attenuating Cognitive Decline as Measured by the Digital Symbol Substitution Test |
31.61; 31 | — |
| SECONDARY Attenuating Cognitive Decline as Measured by the Trail Making Test A and B. |
33.11; 42.68; 122.73; 131.24 | — |
| SECONDARY Physical Mobility as Measured by 4 Meter Walk Test |
0.786; 0.767 | — |
| SECONDARY Physical Mobility as Measured by 6 Minute Walk Test |
359.66; 334.94 | — |
| SECONDARY Tolerability of Oral rhLactoferrin as Assessed by Patient Diary of Total Number of Side Effects |
2.23; 4.77 | — |
| SECONDARY Physical Strength as Measured by Grip Strength |
23.493; 20.294 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02968992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.