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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020501
Receipt No. R000023474
Scientific Title The relationship between the risk of metabolic syndrome and body composition in heavyweight athletes
Date of disclosure of the study information 2016/01/09
Last modified on 2016/01/08

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Basic information
Public title The relationship between the risk of metabolic syndrome and body composition in heavyweight athletes
Acronym The cardiometabolic risk in heavyweight athletes and the change of these risk by dietary counseling intervention.
Scientific Title The relationship between the risk of metabolic syndrome and body composition in heavyweight athletes
Scientific Title:Acronym The cardiometabolic risk in heavyweight athletes and the change of these risk by dietary counseling intervention.
Region
Japan

Condition
Condition Cardiometabolic disease, Metabolic syndrome
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the relationship between the risk of cardiometabolic disease and body composition and to examine whether nutritional intervention including nutritional counseling decrease their risk.
Basic objectives2 Others
Basic objectives -Others The effect of nutritional intervention
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Blood biochemical parameter at baseline and after 12 weeks intervention
Key secondary outcomes Parameters related to body composition including cross-sectional area of abdominal fat and muscle and percent body fat at baseline and after 12 weeks intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Interventional period is about 12 weeks. Some measurements and collecting food records for participants are conducted at baseline. Individual nutritional problems are identified and personal target are determined before their nutritional counseling. During intervention period, an individual telephone call and sending e-mail to check their fasting body mass and food intake and give advices for their nutritional issue are conducted every day and also face to face counseling are carried out every week.
Interventions/Control_2 Nutritional intervention is not conducted in control group. Some measurements and collecting food records for control group are conducted at baseline and after 12 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
18 years-old <=
Age-upper limit
30 years-old >
Gender Male and Female
Key inclusion criteria Heavyweight athletes without disease under treatment and with usual training status during this research period
Key exclusion criteria The person without usualy training by injury and defect
The person with an electrical magnetic or mechanically operated device in/on their body (i.e. cardiac pacemakers, bone growth stimulation device and cochlear implants hearing aids)
The person with an intracranial aneurysm clips that operator cannot identify a non-magnetic apparatus
The person without participating other interventional study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoko Taguchi
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code
Address 2-579-15, Mikajima, Tokorozawa-shi, Saitama, Japan
TEL 04-2947-6778
Email mtaguchi@waseda.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Murata
Organization Waseda University
Division name Graduate school of Sport Sciences
Zip code
Address 2-579-15, Mikajima, Tokorozawa-shi, Saitama, Japan
TEL 04-2947-6778
Homepage URL
Email hiromura@toki.waseda.jp

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization Waseda University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 09 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2013 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 10 Day
Last follow-up date
2013 Year 12 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
2016 Year 01 Month 08 Day
Last modified on
2016 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023474

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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