UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056563 |
|---|---|
| Receipt number | R000064641 |
| Scientific Title | The study to evaluate the effect of the test food on fatigue due to exercise: a randomized, placebo-controlled, double-blind, parallel group study |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2025/07/24 15:57:32 |
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Basic information
Public title
The study to evaluate the effect of the test food on fatigue due to exercise
Acronym
The study to evaluate the effect of the test food on fatigue due to exercise
Scientific Title
The study to evaluate the effect of the test food on fatigue due to exercise: a randomized, placebo-controlled, double-blind, parallel group study
Scientific Title:Acronym
The study to evaluate the effect of the test food on fatigue due to exercise: a randomized, placebo-controlled, double-blind, parallel group study
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of the test food on fatigue due to exercise
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatigue VAS (visual analog scale)
Key secondary outcomes
Endurance performance
POMS2 (Profile of Mood States second edition)
Sleep-quality questionnaire
Blood BAP, dROMs, IL6, and glutathione
Urinary 8-OHdG and biopyrrins
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
Subjects receive the test foods for 4 weeks
Interventions/Control_2
Subjects receive placebo for 4 weeks
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
| 25 | years-old | <= |
Age-upper limit
| 44 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Males and females between the ages of 25 and 44 who have an exercise habit
2) Subjects who agree to the study
Key exclusion criteria
1) Subjects who are unable to refrain from taking health foods, including dietary supplements, or quasi-drugs and over-the-counter drugs that are taken orally that could affect the study.
2) Subjects who habitually take the test food.
3) Subjects who are unable to abstain from smoking.
4) Subjects whose BMI are 25.0 kg/m^2 or more.
5) Subjects who have under treatment or a history of serious disease such as diabetes mellitus, liver disease, renal disease, cardiac disease, circulatory system disease, etc.
6) Subjects who have a disease under treatment or have a pre-existing serious disease that required medication.
7) Subjects who may develop allergic symptoms to the test food or who may develop severe allergic symptoms to the default food to be distributed.
8) Pregnant or planning to become pregnant during the study, and lactating mothers.
9) Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies.
10) Subjects who are likely to change their lifestyle, including diet and exercise, during the study.
11) Subjects who fall under the category of menstrual irregularities.
12) Subjects who are judged as unsuitable for the study by principal investigator.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Takahashi |
Organization
EUPHORIA Co., Ltd.
Division name
Data Management Department
Zip code
102-0085
Address
Iida Bldg. 2nd Floor, 5-5, Rokubancho, Chiyoda-ku, Tokyo, 102-0085, Japan
TEL
+81-3-6388-9260
ryosuke.takahashi@eu-phoria.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Urushizawa |
Organization
EUPHORIA Co., Ltd.
Division name
Data Management Department
Zip code
102-0085
Address
Iida Bldg. 2nd Floor, 5-5, Rokubancho, Chiyoda-ku, Tokyo, 102-0085, Japan
TEL
+81-3-6388-9260
Homepage URL
yuki.urushizawa@eu-phoria.jp
Sponsor or person
Institute
EZAKI GLICO Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
EZAKI GLICO Co., Ltd.
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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
+81-3-5408-1599
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
| 2025 | Year | 01 | Month | 06 | 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
| 2024 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2024 | Year | 12 | Month | 25 | Day |
Last modified on
| 2025 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064641
