Effects of rhLactoferrin on Chronic Inflammation in the Elderly

NCT02968992 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB00094982R21AG053681-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Inflammation; Cognitive Deterioration

Outcome Measures

Primary Outcomes (2)

• The Effect of Rhlactoferrin on Serum Levels of Interleukin-6 (IL-6)

  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

  Baseline and 6 months

• The Effect of Rhlactoferrin on Serum Levels of Tumor Necrosis Factor Alpha Receptor 1 (TNFR1)

  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

  From baseline to 6 months

Secondary Outcomes (6)

• Attenuating Cognitive Decline as Measured by the Digital Symbol Substitution Test

  At 6 months

• Attenuating Cognitive Decline as Measured by the Trail Making Test A and B.

  At 6 months

• Physical Mobility as Measured by 4 Meter Walk Test

  At 6 months

• Physical Mobility as Measured by 6 Minute Walk Test

  At 6 months

• Tolerability of Oral rhLactoferrin as Assessed by Patient Diary of Total Number of Side Effects

  From baseline through 6 months.

Study Arms (2)

rhLactoferrin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

rhLactoferrin DRUG

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.

rhLactoferrin

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Ventria Bioscience: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Jeremy D. Walston

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The primary limitation of this study was the small sample size.

Results Point of Contact

• Title: Jeremy D. Waltson, MD
• Organization: Johns Hopkins University

jwalston@jhmi.edu

410-550-1003

Study Officials

• Jerermy D. Walston, MD

  Johns Hopkins Universtiy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: •Randomized: Participants are assigned to intervention groups by chance
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 21, 2016
• Study Start: August 14, 2017
• Primary Completion: February 25, 2019
• Study Completion: February 25, 2019
• Last Updated: October 3, 2023
• Results First Posted: March 26, 2020

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)