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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037222
Receipt No. R000042437
Scientific Title Trial of the efficacy of food ingredients on fatigue in healthy men and women (SWE-2019-04)
Date of disclosure of the study information 2020/11/30
Last modified on 2020/08/26

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Basic information
Public title Trial of the efficacy of food ingredients on fatigue in healthy men and women (SWE-2019-04)
Acronym Trial of the efficacy of food ingredients on fatigue in healthy men and women
Scientific Title Trial of the efficacy of food ingredients on fatigue in healthy men and women (SWE-2019-04)
Scientific Title:Acronym Trial of the efficacy of food ingredients on 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 Fatigue
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 4
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of the test foods A (8 weeks)
Interventions/Control_2 Intake of the test foods B (8 weeks)
Interventions/Control_3 Intake of the test foods C (8 weeks)
Interventions/Control_4 Intake of the control foods (8 weeks)
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) Women and men aged 40 to 64 years.
2) Person who feels tired with increasing age.
3) Person who feels tired on a daily basis.
4) Person who can come to the medical and inspection organizations for the measurement at the date of visiting.
5) 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 who has difficulty in implementation of exercise tolerance test.
2) Person whose gets high-intensity exercise on a daily basis
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 120

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
Email 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
Email Izumi_Yamasaki@suntory.co.jp

Sponsor
Institute Suntory Wellness Limited
Institute
Department

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
Email 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
2020 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
2019 Year 06 Month 20 Day
Date of IRB
2019 Year 06 Month 20 Day
Anticipated trial start date
2019 Year 09 Month 02 Day
Last follow-up date
2019 Year 12 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 07 Month 01 Day
Last modified on
2020 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042437

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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