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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043644
Receipt No. R000049840
Scientific Title Trial of the efficacy of food ingredients on anti-oxidative effects in healthy men and women
Date of disclosure of the study information 2021/03/18
Last modified on 2021/03/17

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Basic information
Public title Trial of the efficacy of food ingredients on anti-oxidative effects in healthy men and women (SWE-2020-05-HCRINK)
Acronym Trial of the efficacy of food ingredients on anti-oxidative effects in healthy men and women
Scientific Title Trial of the efficacy of food ingredients on anti-oxidative effects in healthy men and women
Scientific Title:Acronym Trial of the efficacy of food ingredients on anti-oxidative effects 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 anti-oxidative effects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes TBARS of red blood cells
LDL oxidation lag time
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 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, menopausal disorder, lung disorder, cardiovascular disorder, diabetes mellitus, food allergy.
5) Investigator's judgment for other reason.
Target sample size 220

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 Kahori
Middle name
Last name Egawa
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 050-3182-0659
Homepage URL
Email Kahori_Egawa@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 Fukuhara Clinic Clinical Trial Review Committee
Address 1-15, Shimamatsuhigashimachi 3 chome, Eniwa-shi, Hokkaido.
Tel 0123-36-8029
Email d-kameda@mediffom.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
2021 Year 03 Month 18 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 Preinitiation
Date of protocol fixation
2021 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2021 Year 07 Month 08 Day
Last follow-up date
2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 03 Month 17 Day
Last modified on
2021 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049840

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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