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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022774
Receipt No. R000026191
Scientific Title Relationship between morphological and mechanical characteristics of human soft tissues and physical functions - a study for the effect of exercise and dietary supplements on human skeletal muscle properties.
Date of disclosure of the study information 2017/06/15
Last modified on 2016/06/14

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Basic information
Public title Relationship between morphological and mechanical characteristics of human soft tissues and physical functions - a study for the effect of exercise and dietary supplements on human skeletal muscle properties.
Acronym A study for the effect of exercise and dietary supplements on human skeletal muscle properties.
Scientific Title Relationship between morphological and mechanical characteristics of human soft tissues and physical functions - a study for the effect of exercise and dietary supplements on human skeletal muscle properties.
Scientific Title:Acronym A study for the effect of exercise and dietary supplements on human skeletal muscle properties.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of exercise and dietary supplements on morphological and mechanical characteristics of human soft tissues and physical functions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Thickness of skeletal muscles
Key secondary outcomes -Body height, mass and composition
-Skeletal muscle mass
-Muscle strength
-Subcutaneous adipose tissue thickness at the thigh
-3D body shape measurement
-Dietary intake

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food Behavior,custom
Interventions/Control_1 Intake of the test dietary supplements for 3 months.
Interventions/Control_2 Intake of the placebo supplements and exercise for 3 months.
Interventions/Control_3 Intake of the test dietary supplements and exercise for 3 months.
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
25 years-old <=
Age-upper limit
39 years-old >=
Gender Female
Key inclusion criteria Healthy women with no regular exercise habit.
Key exclusion criteria -Persons currently suffering from diseases.
-Persons with food allergies.
-Persons pparticipating in other tests.
-Persons suffering from pain due to bone fracture, muscle sprain or strain injuries.
-Persons who are or may be pregnant.
-Persons who are breastfeeding.
-Persons with claustrophobia.
-Persons with implanted metallic materials (pacemakers, artificial joints etc.).
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Kawakami
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code
Address 2-579-15 Mikajima, Tokorozawa city, Saitama
TEL 04-2947-6784
Email ykawa@waseda.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuo Kawakami
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code
Address 2-579-15 Mikajima, Tokorozawa city, Saitama
TEL 04-2947-6784
Homepage URL
Email ykawa@waseda.jp

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization Shiseido 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
Address
Tel
Email

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 早稲田大学所沢キャンパス(埼玉県)

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 15 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
2016 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 17 Day
Last modified on
2016 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026191

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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