UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059502 |
|---|---|
| Receipt number | R000068060 |
| Scientific Title | Confirmation of the fatigue improvement effects of continuous intervention with treatment programs and beverages aimed at fatigue recovery: a parallel-group comparison study |
| Date of disclosure of the study information | 2025/10/22 |
| Last modified on | 2025/10/22 15:56:48 |
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Basic information
Public title
Confirmation of the fatigue improvement effects of continuous intervention with treatment programs and beverages aimed at fatigue recovery
Acronym
Confirmation of the fatigue improvement effects of continuous intervention with treatment programs and beverages aimed at fatigue recovery
Scientific Title
Confirmation of the fatigue improvement effects of continuous intervention with treatment programs and beverages aimed at fatigue recovery: a parallel-group comparison study
Scientific Title:Acronym
Confirmation of the fatigue improvement effects of continuous intervention with treatment programs and beverages aimed at fatigue recovery
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effects of continuous consumption of a dedicated beverage on fatigue recovery during the implementation of a continuous treatment program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Change in fatigue Visual Analogue Scale (VAS) from baseline (pre-treatment on Day 1) to pre-treatment on Day 15
Key secondary outcomes
1. Change in fatigue VAS from baseline (post-treatment on Day 1) to pre-treatment on Day 15
2. Changes in fatigue VAS from baseline (pre-treatment and post-treatment on Day 1) to Day 8 and post-treatment on Day 15
3. Changes in heart rate, low frequency (LF)/high frequency (HF), Coefficient of variation of R-R interval (CVR-R), total power (TP), coefficient of component variance TP (ccvTP), muscle hardness, and salivary cortisol from baseline (pre-treatment and post-treatment on Day 1) to Day 8 and pre- and post-treatment on Day 15
4. Changes in feeling calm/relaxed or anxious/tense VAS and feeling refreshed or depressed VAS from baseline (the day before the intervention start) at each time point from the day of intervention start through Day 14
5. Measured values of fatigue VAS, heart rate, LF/HF, CVR-R, TP, ccvTP, muscle hardness, and salivary cortisol at Day 8 and pre- and post-treatment on Day 15 (intra-group comparisons with pre- and post-treatment on Day 1)
6. Measured values of fatigue VAS, heart rate, LF/HF, CVR-R, TP, ccvTP, muscle hardness, and salivary cortisol at post-treatment on Day 1 (intra-group comparison with pre-treatment on Day 1)
7. Measured values of fatigue VAS, heart rate, LF/HF, CVR-R, TP, ccvTP, muscle hardness, and salivary cortisol at post-treatment on Day 15 (intra-group comparison with pre-treatment on Day 15)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: 15 days
Test product: Citric acid drink
Administration: Prior to performing the standard program and simplified program, dissolve the powder (4.4 g) in 100 mL of water (refrigerated) and drink it.
Interventions/Control_2
Duration: 15 days
Test product: Water
Administration: Prior to performing the standard program and simplified program, drink 100 mL of water (refrigerated).
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Individuals aged 30 or more and less than 60
4. Healthy individuals
5. Individuals who have received an explanation of this study, understand its content, and are able to provide written informed consent
Key exclusion criteria
1. Individuals who undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals who are undergoing treatment for the following chronic conditions:
cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, heart disease (e.g., myocardial infarction, angina pectoris), autonomic dysfunction, or other chronic diseases
4. Individuals who taking antihypertensive drug
5. Individuals who are allergic to medicines or foods related to the test product
6. Individuals who are pregnant, lactating, or planning to become pregnant during this study
7. Individuals who are unable to receive the treatment administered in this study, or who are prohibited from doing so by a physician
8. Individuals who are currently participating in other studies related to fatigue recovery
9. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
10. Individuals who are judged as ineligible to participate in this study by the principal investigator or the study request manager
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.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
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-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 | 10 | Month | 22 | 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 | 10 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Statistical analysis details>
The names and definitions of the subgroup analysis sets are presented below. All subgroups are defined based on the PPS.
Age at registration: < 45 / >= 45
Gender at registration: male / female
Fatigue pre-treatment on Day 1: < median / >= median
Fatigue pre-treatment on Day 15: < median / >= median
LF/HF pre-treatment on Day 1: < median / >= median
LF/HF pre-treatment on Day 15: < median / >= median
CVR-R pre-treatment on Day 1: < median / >= median
CVR-R pre-treatment on Day 15: < median / >= median
TP pre-treatment on Day 1: < median / >= median
TP pre-treatment on Day 15: < median / >= median
ccvTP pre-treatment on Day 1: < median / >= median
ccvTP pre-treatment on Day 15: < median / >= median
Muscle hardness pre-treatment on Day 1: < median / >= median
Muscle hardness pre-treatment on Day 15: < median / >= median
Salivary cortisol pre-treatment on Day 1: < median / >= median
Salivary cortisol pre-treatment on Day 15: < median / >= median
Management information
Registered date
| 2025 | Year | 10 | Month | 22 | Day |
Last modified on
| 2025 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068060
