UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061228 |
|---|---|
| Receipt number | R000070064 |
| Scientific Title | Long-Term Safety Evaluation and Exploratory Assessment of Anti-Fatigue Effects of Continuous Intake of Food Containing Orotic Acid - A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial - |
| Date of disclosure of the study information | 2026/04/26 |
| Last modified on | 2026/04/10 16:22:58 |
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Basic information
Public title
Long-Term Safety Evaluation and Exploratory Assessment of Anti-Fatigue Effects of Continuous Intake of Food Containing Orotic Acid
Acronym
Long-Term Safety Evaluation and Exploratory Assessment of Anti-Fatigue Effects of Continuous Intake of Food Containing Orotic Acid
Scientific Title
Long-Term Safety Evaluation and Exploratory Assessment of Anti-Fatigue Effects of Continuous Intake of Food Containing Orotic Acid
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial -
Scientific Title:Acronym
Long-Term Safety Evaluation and Exploratory Assessment of Anti-Fatigue Effects of Continuous Intake of Food Containing Orotic Acid
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial -
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety of 12 weeks continuous intake of the investigational food in healthy men and women aged 20 to under 65, and to explore its potential effects on fatigue.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Anthropometric measurements (weight, BMI)
-Physiological assessments (blood pressure, pulse)
-Blood tests (hematology, biochemistry)
-Urinalysis
-Incidence of adverse events and side effects
Key secondary outcomes
-POMS2 (Adult Short Version)
-Fatigue Visual Analog Scale (VAS)
-Multidimensional Fatigue Inventory (MFI)-20 (Japanese version)
-Subjective experience questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Participants will take one tablet of the test food daily, allowing it to dissolve in the mouth without chewing.
Interventions/Control_2
Participants will take one tablet of the placebo food daily, allowing it to dissolve in the mouth without chewing.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Aged 20 to under 65
2.Japanese men and women
3.BMI less than 30.0 kg/m^2
4.Able to enter electronic diaries via smartphone or PC
5.Fully informed about the study and voluntarily consented electronically
Key exclusion criteria
1.Currently receiving treatment or medication (including Kampo) for any illness
2.Under dietary or exercise therapy supervised by a physician
3.Current or past serious illness
4.History of gastrointestinal surgery (except appendicitis)
5.Regular use of OTC drugs, quasi-drugs, health foods, supplements or foods with health claims; participation allowed if discontinued after consent
6.Current or past drug or food allergies
7.Habitual excessive alcohol intake (>=40g pure alcohol/day)
8.Habitual excessive smoking (>=21 cigarettes/day)
9.Shift workers with night shifts
10.Plans to significantly change lifestyle (diet, sleep, exercise, etc.) during the study
11.Plans for overseas travel during the study
12.Pregnant, breastfeeding, or planning pregnancy during the study
13.Participation in other clinical trials, within one month prior to consent, currently participating, or plans to participate during the study
14.Deemed unsuitable by the principal or sub-investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Hokazono |
Organization
Sanwa Shurui Co., Ltd
Division name
Research & Department Laboratory
Zip code
879-0495
Address
2231-1 Yamamoto, Usa, Oita
TEL
0978-33-3844
hokazono-h@kokuzo.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Sanwa Shurui 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
Suda Clinic institutional review board
Address
2-8-14, Takadanobaba, Shinjyuku, Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 26 | 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 | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 03 | 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 | 04 | Month | 10 | Day |
Last modified on
| 2026 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070064
