UMIN-CTR Clinical Trial

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

Cardiometabolic disease, Metabolic syndrome

Classification by specialty

Medicine in general	Cardiology	Endocrinology and Metabolism
Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Waseda University

Institute

Department

Personal name

Organization

Waseda University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

01

Month

09

Day

URL releasing protocol

Publication of results

Partially published

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

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 related information

Registered date

2016

Year

01

Month

08

Day

Last modified on

2016

Year

01

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023474