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Effects of rhLactoferrin on Chronic Inflammation in the Elderly (ELCIE)

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ClinicalTrials.gov Identifier: NCT02968992
Recruitment Status : Recruiting
First Posted : November 21, 2016
Last Update Posted : April 9, 2018
Sponsor:
Collaborator:
Ventria Bioscience
Information provided by (Responsible Party):
Johns Hopkins University

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).

Condition or disease Intervention/treatment Phase
Inflammation Cognitive Deterioration Drug: rhLactoferrin Other: Placebo Phase 2

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 datad will complement mobility measures by describing function enacted in daily life

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: •Randomized: Participants are assigned to intervention groups by chance
Primary Purpose: Treatment
Official Title: Effects of Lactoferrin on Chronic Inflammation in the Elderly
Actual Study Start Date : August 14, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Arm Intervention/treatment
Experimental: rhLactoferrin
rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.
Drug: rhLactoferrin
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.

Placebo Comparator: Placebo
Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.
Other: Placebo
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.




Primary Outcome Measures :
  1. The effect of rhlactoferrin on serum levels of Interleukin-6 (IL-6) [ Time Frame: up to 6 months ]
    The effect of rhlactoferrin on serum levels (picogram/milliliter) of Interleukin-6 (IL-6)

  2. The effect of rhlactoferrin on serum levels of tumor necrosis factor alpha receptor 1 (TNFR1) [ Time Frame: up to 6 months ]
    The effect of rhlactoferrin on serum levels (picogram/milliliter) of tumor necrosis factor alpha receptor 1 (TNFR1)


Secondary Outcome Measures :
  1. Attenuating cognitive decline as measured by the digital symbol substitution test [ Time Frame: up to 6 months ]
    The test taker is given a key consisting of numbers 1-9 that are paired with a unique symbol. Below the key is a randomly generated list of the numbers repeated several times. The test taker is allowed 90 seconds to assign the correct symbol to the number on the list. The test administrator then scores the number of correct answers over the 90 second test time, and assigns a total score based on one point for each correct answer.

  2. Attenuating cognitive decline as measured by the trail making test A and B. [ Time Frame: up to 6 months ]
    For test A, the test taker is given a sheet of paper that has the numbers 1-25 within individual circles randomly distributed on the page. The test taker is asked to connect the numbers sequentially over a period of 4 minutes (240 seconds). The score is recorded as the time it takes to complete the task in seconds. For test B, the test taker is given a piece of paper that has numbers 1-13 and letters A-L. Each letter or number is inside of a circle. The test taker must then draw a line from one circled number to the next circled letter (ie. 1 to A to 2 to B to 3 to C etc.) over a period of 6 minutes (360 seconds). The time it takes to record this task correctly is recorded in seconds.

  3. Physical mobility as measured by 4 meter walk test [ Time Frame: up to 6 months ]
    A standard measurement of 4 meters is marked on a flat, long floor surface. The test taker is asked to walk the length at their usual pace while the test giver is recording the time with a stop watch. This test is repeated twice, and the average of the two recorded times is used as the data point.

  4. Physical mobility as measured by 6 minute walk test [ Time Frame: up to 6 months ]
    A measured course is set up in an open area on a hard flat surface. The test taker walks on this measured course for 6 minutes, and the test administrators calculates the distance traveled over 6 minutes. The test taker is allowed to rest as is needed.

  5. Tolerability of oral rhLactoferrin by patient diary [ Time Frame: up to 6 months. ]
    The subject will be given a calendar diary and will be asked to note any illnesses, especially related to gastrointestinal symptoms on the calendar with approximate time. This will be reviewed by study coordinator at least monthly.

  6. Adherence to oral rhLactoferrin by patient diary [ Time Frame: up to 6 months ]
    The participant will receive a calendar diary and will be asked to check off a box twice a day after they have taken their tablets.

  7. Adherence to oral rhLactoferrin by pill counts. [ Time Frame: up to 6 months ]
    The pharmacist will perform a pill count and document the count at monthly visits in order to further document compliance rates.



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968992


Contacts
Contact: Jeremy D. Walston, MD 410-550-1003 jwalston@jhmi.edu
Contact: Ora J White, BS 410-550-2113 owhite1@jhmi.edu

Locations
United States, Maryland
Jeremy D. Walston Recruiting
Baltimore, Maryland, United States, 21224
Contact: Jeremy D. Walston, MD    410-550-2113    jwalston@jhmi.edu   
Contact: Ora J. White, BS    410-550-2113    owhite1@jhmi.edu   
Principal Investigator: Jeremy D. Walston, MD         
Sponsors and Collaborators
Johns Hopkins University
Ventria Bioscience
Investigators
Principal Investigator: Jerermy D. Walston, MD Johns Hopkins Universtiy

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02968992     History of Changes
Other Study ID Numbers: IRB00094982
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Inflammation
Cognition Disorders
Pathologic Processes
Neurocognitive Disorders
Mental Disorders
Lactoferrin
Anti-Infective Agents