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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02968992
Recruitment Status : Completed
First Posted : November 21, 2016
Results First Posted : March 26, 2020
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
Ventria Bioscience
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE November 15, 2016
First Posted Date  ICMJE November 21, 2016
Results First Submitted Date  ICMJE January 30, 2020
Results First Posted Date  ICMJE March 26, 2020
Last Update Posted Date March 26, 2020
Actual Study Start Date  ICMJE August 14, 2017
Actual Primary Completion Date February 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2020)
  • The Effect of Rhlactoferrin on Serum Levels of Interleukin-6 (IL-6) [ Time Frame: Baseline and 6 months ]
    The effect of rhlactoferrin on serum levels (picogram/milliliter) of Interleukin-6 (IL-6) will be assessed as a measure of the percentage change of IL-6 serum levels from baseline
  • The Effect of Rhlactoferrin on Serum Levels of Tumor Necrosis Factor Alpha Receptor 1 (TNFR1) [ Time Frame: From baseline to 6 months ]
    The effect of rhlactoferrin on serum levels (picogram/milliliter) of tumor necrosis factor alpha receptor 1 (TNFR1) assessed as a measure of the percentage change of serum TNFR1 levels from baseline
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2016)
  • The effect of rhlactoferrin on serum levels of Interleukin-6 (IL-6) [ Time Frame: up to 6 months ]
    picogram/milliliter
  • The effect of rhlactoferrin on serum levels of tumor necrosis factor alpha receptor 1 (TNFR1) [ Time Frame: up to 6 months ]
    picogram/milliliter
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2020)
  • Attenuating Cognitive Decline as Measured by the Digital Symbol Substitution Test [ Time Frame: At 6 months ]
    The test taker is given a key consisting of numbers 1-9 that are paired with a unique symbol. 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 and therefore a higher score is a better outcome.
  • Attenuating Cognitive Decline as Measured by the Trail Making Test A and B. [ Time Frame: At 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 complete this task is recorded in seconds.
  • Physical Mobility as Measured by 4 Meter Walk Test [ Time Frame: At 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.
  • Physical Mobility as Measured by 6 Minute Walk Test [ Time Frame: At 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.
  • Tolerability of Oral rhLactoferrin as Assessed by Patient Diary of Total Number of Side Effects [ Time Frame: From baseline through 6 months. ]
    Study coordinators administered side effect questionnaire at each visit and via phone every two weeks during the treatment period.
  • Physical Strength as Measured by Grip Strength [ Time Frame: At 6 months ]
    Hand grip strength is measured by the amount of static force that the hand can squeeze around a dynamometer. An administrator recorded the reading on the device. The force was measured in kilograms.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2016)
  • 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.
  • 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 3 minutes. 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 360 seconds. The time it takes to record this task correctly is recorded in seconds.
  • 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.
  • 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.
  • 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.
  • 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.
  • Adherence to oral rhLactoferrin by pill counts. [ Time Frame: up to 6 months ]
    The research coordinator will perform a pill count at monthly visits in order to further document compliance rates.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of rhLactoferrin on Chronic Inflammation in the Elderly
Official Title  ICMJE Effects of Lactoferrin on Chronic Inflammation in the Elderly
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Inflammation
  • Cognitive Deterioration
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: rhLactoferrin
  • 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.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2019)
36
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2016)
60
Actual Study Completion Date  ICMJE February 25, 2019
Actual Primary Completion Date February 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02968992
Other Study ID Numbers  ICMJE IRB00094982
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Johns Hopkins University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Johns Hopkins University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Ventria Bioscience
Investigators  ICMJE
Principal Investigator: Jerermy D. Walston, MD Johns Hopkins Universtiy
PRS Account Johns Hopkins University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP