UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052281 |
|---|---|
| Receipt number | R000059682 |
| Scientific Title | A study to evaluate the effects of research food on attenuating fatigue sensation -A randomized, double-blind, placebo-controlled, parallel-group study- |
| Date of disclosure of the study information | 2023/09/22 |
| Last modified on | 2024/09/24 08:21:43 |
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Basic information
Public title
A study to evaluate the effects of research food on attenuating fatigue sensation
-A randomized, double-blind, placebo-controlled, parallel-group study-
Acronym
A study to evaluate the effects of research food on attenuating fatigue sensation
Scientific Title
A study to evaluate the effects of research food on attenuating fatigue sensation
-A randomized, double-blind, placebo-controlled, parallel-group study-
Scientific Title:Acronym
A study to evaluate the effects of research food on attenuating fatigue sensation
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of research food on attenuating fatigue sensation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS(fatigue sensation)
Key secondary outcomes
POMS2 (All Items Version)
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food(high-dose) for 4 weeks
Interventions/Control_2
Intake of test food(low-dose) for 4 weeks
Interventions/Control_3
Intake of placebo for 4 weeks
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Healthy males and females aged 40 to 65 years who perceive fatigue sensation in daily life
2)Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Key exclusion criteria
1)Subject who take supplements, health foods, or medicine related to recovery from fatigue or lack of sleep.
2)Subjects with current or past history of serious illness.
3)Subjects who take medicines due to chronic diseases.
4)Subjects who have been diagnosed with chronic fatigue syndrome.
5)Subjects who are considered as a depression based on the screening tests.
6)Subjects who have digestive disease or a history of digestive surgery
7)Subject with BMI >30kg/m2
8)Subjects who have allergy to the research food
9)Subjects who take supplements (EPA/DHA, GABA, citric acid, imidazole dipeptide astaxanthin, coenzyme Q10, etc.) that may affect the research results.
10)Subjects who take general beverages that may affect fatigue, such as Red Bull, Oronamin C, Monster, etc.
11)Subjects who have the habit to do regularly vigorous exercise
12)Subjects who have a habit of drinking more than 20 g/day of pure alcohol, 5 days or more a week.
13)Subjects who are unable to stop drinking from 2 days before screening test and each test.
14)Shift worker or midnight shift worker
15)Subjects who have plans to travel abroad, move, etc. during the research period and have major lifestyle changes.
16)Subjects who are considered as an inappropriate candidate based on the screening tests by the principal doctor or co-research doctor.
17)Subjects who are pregnant, lactating, or planning to get pregnant
18)Subjects who donated blood of over 200 mL in the past 1 month or over 400 mL in the past 3 months
19)Subjects who are planning to participate another clinical study during the study period
20)Subjects who are considered as an inappropriate candidate for other reasons by the principal doctor or co-research doctor.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Tsuge |
Organization
General incorporated foundation Seamen's Insurance Association
Shinagawa Season Terrace Care Clinic
Division name
Doctor
Zip code
108-0075
Address
1-2-70 Konan, Minato-ku, Tokyo
TEL
03-3452-3382
shibaura@sempos.or.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Kobayashi 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.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
| 2023 | Year | 09 | 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
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 22 | Day |
Last modified on
| 2024 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059682
