Clinical trial NCT03612752: CMI-168 on Cognitive Function in Healthy Middle-aged Men and Women
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of a Peptide-protein Extract (CMI-168) on Cognitive Function in Healthy Middle-aged Men and Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Change
Keywords: Chicken essence, cognitive function
Lead sponsor: Cerebos Pacific Limited
Sponsor class: INDUSTRY
First posted: 2018-08-02
Enrollment: 90
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators propose to conduct the present study in order to primarily assess the effects of CMI-168 in neurocognition enhancement. Studies have shown that episodic memory performance is declined in elder populations showing elevated cortisol levels and cognitive decline is accelerated with greater levels of self-reporting perceived stress . Additionally, stress-related disorders such as depression and anxiety adversely affect and impair cognitive function. Given the significant role of chronic stress, sleep, depression and anxiety in impairing memory and learning performance, questionnaires used to measure the following parameters of stress (Perceived Stress Scale, PSS), sleep (Pittsburg Sleep Quality Index, PSQI), anxiety (State-Trait Anxiety Inventory, STAI) and depression (Beck Depression Inventory, BDI) have been incorporated into this study design. Additionally, levels of Brain-Derived Neurotrophic Factor (BDNF), a protein involved in neuronal survival and synaptic plasticity of the central and peripheral nervous system, have been reported to be significantly different in patients with depression or neurological disorders . The investigators will also examine the physiological levels of cortisol and BDNF in these subjects to determine their effect of CMI-168 supplementation on these measures, as well as the implications on cognition.

Detailed description: Study participation will last approximately 14 weeks, comprising of up to 4 weeks for screening, 8 weeks-blinded supplementation period and 2 weeks post-supplementation period. During the 8 weeks period, subjects will take either 2 study tablets of CMI-168 or 2 tablets of matching placebo once daily in the morning. Supplementation will be stopped after 56 days and after another 14 days, subjects will be re-assessed.

Key assessment of the screening period will be the cognitive testing using the Cambridge Neuropsychological Test Automated Battery (CANTAB) to ensure that the subjects fall within the normal cognitive range for their ages. The study aims to only include subjects with normal cognition and showing no perceptible signs of cognitive impairment at screening (Visit 1). Subjects showing cognition abnormal cognition scores during the screening stage by the CANTAB assessment will not be included in the next stages of the study. After a screening period of 3 to 28 days, eligible subjects will be randomized 1:1 ratio to two treatment arms.

* CMI-168 (2 tablet, once daily, 56 days).
* Placebo (2 tablets once daily, 56 days)

Following randomisation,the various assessments including cognitive tests, questionnaires, event related potential and blood samples will be administered or taken at Visit 2 (Baseline, start of supplementation), Visit 3 (Day 28 supplementation) and Visit 4 (Day 56 supplementation) and Visit 5 (Day 70-2 weeks after termination of supplementation). Subject completion of the study will be defined as completing the assessments at Visit 5. The different tests will be administered according to the schedule of assessments below.

Eligibility criteria: Inclusion Criteria:

* Institutional Review Board approved written informed consent and privacy language as per national regulations must be obtained from the patient or legally authorized representative prior to any clinical study-related procedures
* Subject is an otherwise healthy male/female between 35-65 years of age during the study period.
* Patient has a body mass index range of 18.0 to 40.0 kg/m2, inclusive, and weighs at least 40 kg at screening
* Patient agrees not to participate in another interventional study while participating in the present study, defined as signing the informed consent form until completion of the study.
* Ability to understand and write Taiwanese Traditional Chinese or at least have completed Taiwan high school education
* Perceived Stress Scale Score\> 20
* Within normal cognition range as assessed by CANTAB battery

Exclusion Criteria:

* Inability to participate in the evaluation of the study
* Subject is pregnant at the time of the screening assessment
* Active viral infection or bacterial infection based on clinical observations
* Visual or hearing impairment sufficient to preclude cooperation with neurocognitive testing
* Long-term consumption of dietary supplement or herbal products likely to have an effect on memory
* Subjects intolerant or allergic to protein-based food or supplement
* Subjects with significant cognitive impairment including already being diagnosed with Alzheimer's disease, Parkinson's disease, schizophrenia or dementia.
* History of cardiovascular disease, respiratory disease, head injury, cancer, diabetes or neuropsychological disease
* Life threatening pathology (such as cancer) in remission for less than 1 year or still ongoing
* Psychological or linguistic incapability to sign the informed consent
* Anti-depressant treatment stopped since less than 3 months or still ongoing
* History of allergy to chicken meat
* Pregnant or lactating women
* Smoking more than 10 cigarettes per day
* Suspected or known alcohol abuse or addiction
* Subjects with any other conditions or diseases that investigator consider as not appropriate to be entered in the study

Primary outcomes:
measure: Change of Cognitive function
timeFrame: From Day 0 to Day 28, Day 56 and Day 70
measure: Change of Word Lists Subtest of the Weschler Memory Scale 3rd edition
timeFrame: From Day 0 to Day 28, Day 56 and Day 70
measure: Change of Logical Memory Subtest of Weschler Memory Scale 3rd edition
timeFrame: From Day 0 to Day 28, Day 56 and Day 70
measure: Change of Family Pictures Subtest of Weschler Memory Scale 3rd edition
timeFrame: From Day 0 to Day 28, Day 56 and Day 70
Secondary outcomes:
measure: Change of serum ALT
timeFrame: From Day 0 to Day 28, Day 56 and Day 70
measure: Change of serum AST
timeFrame: From Day 0 to Day 28, Day 56 and Day 70
measure: Change of serum BUN
timeFrame: From Day 0 to Day 28, Day 56 and Day 70
measure: Change of serum creatinin
timeFrame: From Day 0 to Day 28, Day 56 and Day 70
measure: Change of serum T3
timeFrame: From Day 0 to Day 28, Day 56 and Day 70
measure: Change of serum T4
timeFrame: From Day 0 to Day 28, Day 56 and Day 70
measure: Change of serum TSH
timeFrame: From Day 0 to Day 28, Day 56 and Day 70
measure: Change of serum cortisol at 8 am
timeFrame: From Day 0 to Day 28, Day 56 and Day 70
measure: Change of serum fasting sugar
timeFrame: From Day 0 to Day 28, Day 56 and Day 70
measure: Change of Event related potential P300
timeFrame: From Day 0 to Day 28, Day 56 and Day 70
measure: Change of Perceived Stress Scale (PSS)
timeFrame: From Day 0 to Day 28, Day 56 and Day 70
measure: Change of State-Trait Anxiety Inventory (STAI)
timeFrame: From Day 0 to Day 28, Day 56 and Day 70
measure: Change of Beck Depression Inventory (BDI)
timeFrame: From Day 0 to Day 28, Day 56 and Day 70
measure: Change of Pittsburgh Sleep Quality Index (PSQI)
timeFrame: From Day 0 to Day 28, Day 56 and Day 70
measure: Change of serun brain-derived neurotrophic factor (BDNF)
timeFrame: From Day 0 to Day 28, Day 56 and Day 70
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University - Shuang Ho Hospital
Study officials:
affiliation: Taipei Medical University
name: Chaurjong Hu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu D, Yang CC, Chen KY, Lin YC, Wu PJ, Hsieh PH, Nakao Y, Ow MYL, Hsieh YC, Hu CJ. Hydrolyzed Chicken Extract (ProBeptigen(R)) on Cognitive Function in Healthy Middle-Aged People: A Randomized Double-Blind Trial. Nutrients. 2020 May 10;12(5):1362. doi: 10.3390/nu12051362.