UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060592 |
|---|---|
| Receipt number | R000069287 |
| Scientific Title | Exploratory Study on the Effects of a Fursultiamine-Containing Quasi-Drug on Runner Condition |
| Date of disclosure of the study information | 2026/02/05 |
| Last modified on | 2026/02/04 12:53:15 |
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Basic information
Public title
Exploratory Single-Arm Nutritional Intervention Study on Condition Changes in Recreational Runners
Acronym
Single-Arm Intervention in Recreational Runners
Scientific Title
Exploratory Study on the Effects of a Fursultiamine-Containing Quasi-Drug on Runner Condition
Scientific Title:Acronym
Single-Arm Intervention in Recreational Runners
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily examine the effects of a vitamin B-complex nutritional intervention on health-related condition indicators.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective wellness indices (Sleep, Stress, Fatigue, Muscle soreness, and Hooper's score)
Key secondary outcomes
Sleeping heart rate, sleeping heart rate variability, total sleep duration, running distance, running time, running speed, and running heart rate
Urine-based estimated absorption (Protein, Vitamin D, Vitamin B1, Vitamin B2, Niacin, Vitamin B6, Folate, Pantothenic acid, and Biotin. Minerals: Sodium, Potassium, Calcium, Magnesium, Phosphorus, Zinc, Selenium, and Molybdenum)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
nutritional supplementation
Interventions/Control_2
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
| 49 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Recreational runners aged 18-49 years
2.Male
3.Individuals who have received an explanation of the study, are able to understand its content, and have provided written informed consent
4.Individuals who own a Garmin smartwatch
Key exclusion criteria
1.Individuals who are unable to abstain from smoking.
2.Individuals with a Body Mass Index (BMI) of 30.0 $kg/m^2$ or higher.
3.Individuals with serious diseases (such as diabetes, liver disease, kidney disease, heart disease, or cardiovascular disease) or a history of such diseases.
4.Individuals currently undergoing treatment for a disease, or those with a history of serious illness requiring medication.
5.Individuals taking pharmacy-only medicines, OTC drugs, or quasi-drugs for the purpose of nutritional supplementation (such as vitamins) or anti-fatigue.
6.Individuals who may experience allergic symptoms to the test products or severe allergic symptoms to the provided standardized meals.
7.Individuals who participated in other clinical studies within one month prior to providing consent for this study, or those scheduled to participate in other clinical studies after providing consent.
8.Individuals who may change their lifestyle habits, including diet and exercise, during the study period.
9.Others judged unsuitable for the study by the principal investigator.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Takahashi |
Organization
EUPHORIA Co., Ltd.
Division name
Corporate Division
Zip code
102-0083
Address
10th Floor, Crystal City East Building, 4-8-1 Kojimachi, Chiyoda-ku, Tokyo, Japan
TEL
03-6388-9260
ryosuke.takahashi@eu-phoria.jp
Public contact
Name of contact person
| 1st name | Fuminori |
| Middle name | |
| Last name | Takayama |
Organization
EUPHORIA Co., Ltd.
Division name
Corporate Division
Zip code
102-0083
Address
10th Floor, Crystal City East Building, 4-8-1 Kojimachi, Chiyoda-ku, Tokyo, Japan
TEL
03-6388-9260
Homepage URL
fuminori.takayama@eu-phoria.jp
Sponsor or person
Institute
EUPHORIA Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Alinamin Pharmaceutical Co., Ltd.
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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, Japan
Tel
03-5408-1599
shiba_palace@s-palace-clinic.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 05 | 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
23
Results
Results date posted
| 2026 | Year | 02 | Month | 04 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Results have not yet been published. Data will be registered following acceptance by a peer-reviewed journal.
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 05 | 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 | 02 | Month | 05 | Day |
Last modified on
| 2026 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069287
