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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036638
Receipt No. R000041733
Scientific Title Study on the actions of MAF (high molecular-weight polyphenol) on the effects of light exercise conducted by middle-aged and elderly women
Date of disclosure of the study information 2019/05/06
Last modified on 2019/05/02

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Basic information
Public title Study on the actions of MAF (high molecular-weight polyphenol) on the effects of light exercise conducted by middle-aged and elderly women
Acronym Study on the actions of MAF on the effects of light exercise
Scientific Title Study on the actions of MAF (high molecular-weight polyphenol) on the effects of light exercise conducted by middle-aged and elderly women
Scientific Title:Acronym Study on the actions of MAF on the effects of light exercise
Region
Japan

Condition
Condition lifestyle-related diseases
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of MAF on the effects of light exercise conducted by middle-aged and elderly women
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes physical fitness age, before and after 80 days intervention study
Key secondary outcomes muscle mass, strength and fat mass, before and after 80 days intervention study

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 Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 placebo
Interventions/Control_2 intervention period: 80 days
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
55 years-old <=
Age-upper limit
69 years-old >=
Gender Female
Key inclusion criteria Curves member who participates regular program for more than 2 times/week
Key exclusion criteria have serious disease
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Tohru
Middle name
Last name Takemasa
Organization University of Tsukuba
Division name Faculty of Health and Sport Sciences
Zip code 305-8574
Address Ten-noudai 1-1-1, Tsukuba, Ibaraki
TEL 029-853-2622
Email takemasa.tohru.gm@u.tsukuba.ac.jp

Public contact
Name of contact person
1st name Tohru
Middle name
Last name Takemasa
Organization University of Tsukuba
Division name Faculty of Health and Sport Sciences
Zip code 305-8574
Address Ten-noudai 1-1-1, Tsukuba, Ibaraki
TEL 029-853-2622
Homepage URL
Email takemasa.tohru.gm@u.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Curves Japan
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 University of Tsukuba
Address Ten-noudai 1-1-1, Tsukuba, Ibaraki
Tel 029-859-2571
Email hitorinri@un.tsukuba.ac.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
2019 Year 05 Month 06 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 70
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 No longer recruiting
Date of protocol fixation
2018 Year 11 Month 14 Day
Date of IRB
2018 Year 11 Month 20 Day
Anticipated trial start date
2019 Year 05 Month 06 Day
Last follow-up date
2019 Year 07 Month 31 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 05 Month 02 Day
Last modified on
2019 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041733

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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