UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041552 |
|---|---|
| Receipt number | R000047441 |
| Scientific Title | Trial of the efficacy of food ingredients on daily fatigue in healthy men and women (SWE-2020-02) |
| Date of disclosure of the study information | 2021/11/30 |
| Last modified on | 2021/06/16 11:32:00 |
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Basic information
Public title
Trial of the efficacy of food ingredients on daily fatigue in healthy men and women (SWE-2020-02)
Acronym
Trial of the efficacy of food ingredients on daily fatigue in healthy men and women
Scientific Title
Trial of the efficacy of food ingredients on daily fatigue in healthy men and women (SWE-2020-02)
Scientific Title:Acronym
Trial of the efficacy of food ingredients on daily fatigue in healthy men and women
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of food ingredients on fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analog Scale Fatigue(at 4th week, 8th week after intake of the test food)
Key secondary outcomes
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
Intake of the test foods (8 weeks)
Interventions/Control_2
Intake of the control foods (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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy men and women aged 40 to 64 years.
2) Person who feels tired on a daily basis.
3) Person who can understand the purpose and content of this study and agree in writing to participate in this study.
Key exclusion criteria
1) Person whose keep irregular hours such as shift work.
2) Heavy drinker of alcohol.
3) Use of product affecting the data of this study, such as food for specified health use, food with function claims, and medicine.
4) Presence of previous and present disease such as chronic fatigue syndrome, sleep apnea syndrome, menopause, lung disorder, cardiovascular disorder, diabetes mellitus, food allergy.
5) Investigator's judgment for other reason.
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Tanaka |
Organization
Suntory Wellness Limited
Division name
Institute For Health Care Science
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, 619-0284, Japan
TEL
050-3182-0590
Takao_Tanaka@suntory.co.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Yamasaki |
Organization
Suntory Wellness Limited
Division name
Institute For Health Care Science
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, 619-0284, Japan
TEL
050-3182-0648
Homepage URL
Izumi_Yamasaki@suntory.co.jp
Sponsor or person
Institute
Suntory Wellness Limited
Institute
Department
Personal name
Funding Source
Organization
None
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
Miura Clinic Research Ethnics Committee
Address
Higashitenma Bldg. 9F, 1-7-17 Higashitenma, Kita-ku, Osaka, 530-0044, Japan
Tel
06-6135-5200
info@miura-cl.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
| 2021 | Year | 11 | Month | 30 | 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
| 2020 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 02 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 26 | Day |
Last modified on
| 2021 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047441
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
