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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active arm | Experimental | CMI-168 |
|
| Placebo arm | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMI-168 | Dietary Supplement | Dietary supplement |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of serum ALT | serum ALT | From Day 0 to Day 28, Day 56 and Day 70 |
| Change of serum AST | serum AST | From Day 0 to Day 28, Day 56 and Day 70 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dean Wu, PhD | Contact | 886-9-70746912 | tingyu02139@gmail.com | |
| Chaurjong Hu, MD | Contact | 886-9-70746908 | chaurjongh@tmu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Chaurjong Hu, MD | Taipei Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University - Shuang Ho Hospital | Recruiting | New Taipei City | 23561 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32397609 | Derived | 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. |
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| Other |
Placebo |
|
| Change of serum BUN | serum BUN | From Day 0 to Day 28, Day 56 and Day 70 |
| Change of serum creatinin | serum creatinin | From Day 0 to Day 28, Day 56 and Day 70 |
| Change of serum T3 | serum T3 | From Day 0 to Day 28, Day 56 and Day 70 |
| Change of serum T4 | serum T4 | From Day 0 to Day 28, Day 56 and Day 70 |
| Change of serum TSH | serum TSH | From Day 0 to Day 28, Day 56 and Day 70 |
| Change of serum cortisol at 8 am | serum cortisol at 8 am | From Day 0 to Day 28, Day 56 and Day 70 |
| Change of serum fasting sugar | serum fasting sugar | From Day 0 to Day 28, Day 56 and Day 70 |
| Change of Event related potential P300 | Event related potential P300 | From Day 0 to Day 28, Day 56 and Day 70 |
| Change of Perceived Stress Scale (PSS) | Perceived Stress Scale (PSS) | From Day 0 to Day 28, Day 56 and Day 70 |
| Change of State-Trait Anxiety Inventory (STAI) | State-Trait Anxiety Inventory (STAI) | From Day 0 to Day 28, Day 56 and Day 70 |
| Change of Beck Depression Inventory (BDI) | Beck Depression Inventory (BDI) | From Day 0 to Day 28, Day 56 and Day 70 |
| Change of Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index (PSQI) | From Day 0 to Day 28, Day 56 and Day 70 |
| Change of serun brain-derived neurotrophic factor (BDNF) | serum brain-derived neurotrophic factor (BDNF) | From Day 0 to Day 28, Day 56 and Day 70 |