UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057884 |
|---|---|
| Receipt number | R000065958 |
| Scientific Title | Test to examine the effect of test food intake on fatigue |
| Date of disclosure of the study information | 2025/05/16 |
| Last modified on | 2026/05/21 11:08:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Test to examine the effect of test food intake on fatigue
Acronym
Test to examine the effect of test food intake on fatigue
Scientific Title
Test to examine the effect of test food intake on fatigue
Scientific Title:Acronym
Test to examine the effect of test food intake on fatigue
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of the consumption of the test food on the feeling of fatigue after 8 consecutive weeks of consumption of the test food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatigue VAS Survey
(Week 0, Week 4, Week 8)
Key secondary outcomes
* Secondary endpoints
1) Questionnaire survey using VAS method(1)
2) Chalder Fatigue Scale(1)
3) POMS2 Japan version (all terms version)(1)
* Safety Endpoints
1) Blood pressure, pulsation(2)
2) Weight, body fat percentage, BMI(2)
3) Doctor's questions(2)
4) Adverse events(3)
5) Subject's diary(4)
(1):Week 0, Week 4, Week 8
(2):Week 0, Week 8
(3):Week 8
(4):Listed daily from the start of the home survey to the end of the exam
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
Oral intake of the test food (2 bottles in a day; 8 weeks).
Interventions/Control_2
Oral intake of the placebo food (2 bottles in a day; 8 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Men and women between 20 and 64 years of age at the time of obtaining consent to participate in the study.
2) Individuals who are healthy and have no chronic physical disease including skin disease.
3) Individuals with transient fatigue in daily life (transient fatigue from work, housework, schoolwork, etc.)
4) Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, voluntarily volunteer to participate, and are able to consent to participation in the study in writing.
5) Individuals who can come to the designated venue for this study and be inspected.
6) Individuals judged appropriate for the study by the principal.
Key exclusion criteria
1) Individuals with chronic illnesses and individuals undergoing treatment for any illness.
2) Individuals with a history or current history of chronic fatigue syndrome, mental illness, sleep disorders, hypertension, diabetes, dyslipidemia or serious illness.
3) Individuals with a history of serious or current illness in the liver, kidney, heart, lungs, blood, or gastrointestinal tract.
4) Individuals with serious anemia.
5) Individuals with a habit of taking or applying drugs for the purpose of disease treatment in the past month.
6) Individuals whose BMI is over 30 kg/m2.
7) Individuals who may develop allergic symptoms to any ingredient in the tested food, or to any other food or drug.
8) Individuals who are currently, or have been within the past 3 months, habitual consumers of food for specified health uses, functional foods, health foods, supplements, etc., or who plan to consume such foods during the study period.
9) Individuals whose daily alcohol consumption exceeds 40 g/day for men and 20 g/day for women on a weekly average of pure alcohol equivalent.
10) Individuals with irregular lifestyles, such as shift work, night work, etc.
11) Individuals with possible changes of life style during the test period.
12) Individuals who are currently participating in another human clinical trial or who have not yet completed 3 months of participation in another human clinical trial.
13) Individuals who are pregnant, lactating or can become pregnant and intend to become pregnant during the study period.
14) Individuals who work for companies that develop, manufacture or sell health and functional foods and cosmetics for themselves or their family members.
15) Individuals judged inappropriate for the study by the principal.
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Aoki |
Organization
ASAHI SOFT DRINKS CO., LTD.
Division name
Marketing Division
Zip code
130-8602
Address
1-23-1 Azumabashi, Sumida-ku, Tokyo
TEL
0570-005-112
shuichi.aoki@asahiinryo.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ASAHI SOFT DRINKS 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.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
| 2025 | Year | 05 | Month | 16 | 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
Completed
Date of protocol fixation
| 2025 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 16 | Day |
Last modified on
| 2026 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065958
