CMI-168 on Cognitive Function in Healthy Middle-aged Men and Women

NCT03612752 | Unknown

• 1 other identifier: N201711060
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Change

Keywords

Chicken essence, cognitive function

Outcome Measures

Primary Outcomes (4)

• Change of Cognitive function

  Cambridge Neuropsychological Test Automated Battery (CANTAB)

  From Day 0 to Day 28, Day 56 and Day 70

• Change of Word Lists Subtest of the Weschler Memory Scale 3rd edition

  Word Lists Subtest of the Weschler Memory Scale 3rd edition

  From Day 0 to Day 28, Day 56 and Day 70

• Change of Logical Memory Subtest of Weschler Memory Scale 3rd edition

  Logical Memory Subtest of Weschler Memory Scale 3rd edition

  From Day 0 to Day 28, Day 56 and Day 70

• Change of Family Pictures Subtest of Weschler Memory Scale 3rd edition

  Family Pictures Subtest of Weschler Memory Scale 3rd edition

  From Day 0 to Day 28, Day 56 and Day 70

Secondary Outcomes (15)

• Change of serum ALT

  From Day 0 to Day 28, Day 56 and Day 70

• Change of serum AST

  From Day 0 to Day 28, Day 56 and Day 70

• Change of serum BUN

  From Day 0 to Day 28, Day 56 and Day 70

• Change of serum creatinin

  From Day 0 to Day 28, Day 56 and Day 70

• Change of serum T3

  From Day 0 to Day 28, Day 56 and Day 70

Study Arms (2)

Active arm

EXPERIMENTAL

CMI-168

Dietary Supplement: CMI-168

Placebo arm

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

CMI-168 DIETARY_SUPPLEMENT

Dietary supplement

Active arm

Placebo OTHER

Placebo

Placebo arm

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cerebos Pacific Limited: lead

Study Sites (1)

Taipei Medical University - Shuang Ho Hospital

New Taipei City, 23561, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 32397609 DERIVED

Study Officials

• Chaurjong Hu, MD

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dean Wu, PhD

CONTACT

886-9-70746912; tingyu02139@gmail.com

Chaurjong Hu, MD

CONTACT

886-9-70746908; chaurjongh@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: August 2, 2018
• Study Start: June 19, 2018
• Primary Completion: February 28, 2019
• Study Completion: March 31, 2019
• Last Updated: August 2, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)