UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063355 |
|---|---|
| Receipt number | R000072514 |
| Scientific Title | Effect of NVIF2026-01 intake on autonomic nervous system activity and task performance |
| Date of disclosure of the study information | 2026/10/20 |
| Last modified on | 2026/10/20 16:52:51 |
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Basic information
Public title
Effect of NVIF2026-01 intake on autonomic nervous system activity and task performance
Acronym
Effect of NVIF2026-01 intake on autonomic nervous system activity and task performance
Scientific Title
Effect of NVIF2026-01 intake on autonomic nervous system activity and task performance
Scientific Title:Acronym
Effect of NVIF2026-01 intake on autonomic nervous system activity and task performance
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of NVIF2026-01 on autonomic nervous system activity and task performance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate-based physiological responses
Task performance measures
Key secondary outcomes
Subjective questionnaire responses
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Placebo drink (a single time intake) -> Washout (not less than 1day) -> Test drink, containing NVIF2026-01 (a single time intake)
Interventions/Control_2
Test drink, containing NVIF2026-01 (a single time intake) -> Washout (not less than 1 day) -> Placebo drink (a single time intake)
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Individuals who are male or female employees of Nagase Viita Co., Ltd., aged 18 to 65 years, and who have been employed by the company for at least one year.
2) Individuals with a body mass index (BMI) of less than 30 kg/m2.
3) Individuals who do not regularly use medications that may affect the study evaluations and who are willing and able to temporarily discontinue their regular dietary supplement intake during the study period.
4) Individuals who are not pregnant, are not suspected of being pregnant, and are not breastfeeding during the study period.
5) Individuals who do not have a known sensitivity to caffeine.
6) Individuals who do not engage in shift work.
7) Individuals who are able to participate in all scheduled study procedures.
8) Individuals who are willing and able to comply with all study requirements.
Key exclusion criteria
Individuals deemed unsuitable for the study by the Principal Investigator or Investigator.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Oka |
Organization
Nagase Viita Co., Ltd.
Division name
Research & Development Division, Material Development Department
Zip code
702-8006
Address
675-1, Fujisaki, Naka-ku, Okayama
TEL
0862763141
yu.oka@nagase.co.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Oka |
Organization
Nagase Viita Co., Ltd.
Division name
Research & Development Division, Material Development Department
Zip code
702-8006
Address
675-1, Fujisaki, Naka-ku, Okayama
TEL
0862763141
Homepage URL
yu.oka@nagase.co.jp
Sponsor or person
Institute
Nagase Viita Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Nagase Viita Co., Ltd.
Address
675-1, Fujisaki, Naka-ku, Okayama
Tel
086-276-3141
NVI800014@nagase.co.jp
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
ナガセヴィータ株式会社（岡山県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 20 | Day |
Last modified on
| 2026 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072514
