UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057644 |
|---|---|
| Receipt number | R000065604 |
| Scientific Title | Proof of concept trial: Effects of Choline derivatives Supplementation on Validated Subjective and Objective Markers of Mood and Cognitive Function in Healthy Male Volunteers |
| Date of disclosure of the study information | 2025/04/17 |
| Last modified on | 2025/04/17 16:15:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Proof of concept trial: Effects of Choline derivatives Supplementation on Validated Subjective and Objective Markers of Mood and Cognitive Function in Healthy Male Volunteers
Acronym
Proof of concept trial: Effects of Choline derivatives Supplementation on Mood and Cognitive Function
Scientific Title
Proof of concept trial: Effects of Choline derivatives Supplementation on Validated Subjective and Objective Markers of Mood and Cognitive Function in Healthy Male Volunteers
Scientific Title:Acronym
Proof of concept trial: Effects of Choline derivatives Supplementation on Mood and Cognitive Function
Region
| North America |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study will assess the potential benefits of a Choline derivatives on brain activation, emotional states, and cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective questionnaires using Visual Analog Scale (VAS) for emotional states, Cognitive function, Brain activation via Electroencephalography (EEG)
Key secondary outcomes
Comprehensive side effect profile- Confirmation of medical history during study period
Adverse event monitoring- Occurrence of adverse events
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single Intakes of test capsule
Interventions/Control_2
Single Intakes of test capsule
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
Provide voluntary signed and dated informed consent.
Be in good health and able to participate in cognitive performance testing as determined by medical history and routine blood chemistries.
Between 18 and 35 years of age (inclusive).
Body Mass Index of 18.5-31.9 (inclusive).
Body weight of at least 120 pounds.
Normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5-minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
Normal supine, resting heart rate (<90 per minute).
Agrees to maintain their existing dietary and physical activity patterns throughout the study period.
If a dietary supplement was initiated within the past month, the participant is willing to discontinue supplement use followed by a 2-week washout prior to participation in the study.
Willing to duplicate their previous 24-hour diet, refrain from caffeine for 12 hours, refrain from alcohol and exercise for 24 hours prior to each trial, and fast for 10 hours prior to each visit.
Key exclusion criteria
Smokes more than 10 cigarettes per day or uses other nicotine products (i.e., cigars, vape, patches, gum, etc) that deliver a similar amount of nicotine.
Current use of any nootropic dietary supplements (e.g., Ginkgo biloba, L-theanine, choline, Lion's mane, creatine, etc.) or medications (e.g., piracetam, Adderall, modafinil, etc.) that may confound the study or its endpoints.
Medical history of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
Other known gastrointestinal or metabolic diseases that might impact nutrient absorption, distribution, metabolism, or excretion (e.g., intestinal malabsorption, electrolyte abnormalities, diabetes, thyroid disease, adrenal disease, hypogonadism, short bowel syndrome, diarrheal illnesses, history of colon resection, gastric ulcer, reflux disease, gastroparesis, Inborn-Errors-of-Metabolism, etc.).
Chronic medically diagnosed inflammatory condition or disease (e.g., rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV-AIDS, etc.).
Medical history of a cognitive (i.e., ADD-ADHD) or psychiatric disorder.
Currently using medications to treat anxiety or depression.
Have an irregular sleep pattern (i.e., shift workers) or inadequate sleep schedule (i.e., less than 6 hours per night).
Known sensitivity, allergy, or intolerability to any ingredient in the test products.
Individuals who are cognitively impaired and/or who are unable to give informed consent.
Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoint or place the subject at increased risk of harm if they were to participate.
t at increased risk of harm if they were to participate.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Tim |
| Middle name | |
| Last name | Ziegenfuss |
Organization
The Center for Applied Health Sciences
Division name
CEO
Zip code
44406
Address
6570 Seville Dr, Canfield, OH, USA
TEL
(330)962-6927
JH@appliedhealthsciences.org
Public contact
Name of contact person
| 1st name | Jennifer |
| Middle name | |
| Last name | Sandrock |
Organization
The Center for Applied Health Sciences
Division name
Chief Operating Officer
Zip code
44406
Address
6570 Seville Dr, Canfield, OH, USA
TEL
(330)962-6927
Homepage URL
JH@appliedhealthsciences.org
Sponsor or person
Institute
Kirin Holdings Company, Limited
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Advarra IRB
Address
6100 Merriweather Dr., Suite 600 Columbia, Maryland 21044-2115
Tel
(866)992-4724
adviser@advarra.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
The Center for Applied Health Sciences
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 17 | Day |
Last modified on
| 2025 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065604
