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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010809
Receipt No. R000012541
Scientific Title Tenshi Health and Nutrition Clinic - Prevention and Alleviation Effects on Metabolic Syndrome -
Date of disclosure of the study information 2013/05/27
Last modified on 2019/12/02

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Basic information
Public title Tenshi Health and Nutrition Clinic - Prevention and Alleviation Effects on Metabolic Syndrome -
Acronym Tenshi Health and Nutrition Clinic - Prevention and Alleviation Effects on Metabolic Syndrome -
Scientific Title Tenshi Health and Nutrition Clinic - Prevention and Alleviation Effects on Metabolic Syndrome -
Scientific Title:Acronym Tenshi Health and Nutrition Clinic - Prevention and Alleviation Effects on Metabolic Syndrome -
Region
Japan

Condition
Condition Men and women aged 40 and over without a critical disease
Classification by specialty
Medicine in general Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare groups which received intervention for eating behaviors physical activity and rest versus the control group.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The stage of change in exercise behavior, self efficacy (SE), social support (SS) scores, physical fitness, body composition, blood test results and nutrient intake
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 Measurement of body size and blood pressure, blood collection (biochemical analysis), dietary survey and lifestyle survey.
The same investigation is conducted in three months.
Interventions/Control_2 The intervention group received both group and individual support about eating behaviors, and physical activity and rest 6 times in three months.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Healthy male and female volunteers
2. Aged 40 and over
3. Be able to provide written informed consent
Key exclusion criteria with a critical disease
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Manabu
Middle name
Last name Musashi
Organization Tenshi College
Division name School of Nursing and Nutrition
Zip code 0650013
Address Higashi-ku, Kita-13 Higashi-3, Sapporo, Japan
TEL 011-741-1051
Email musashi@tenshi.ac.jp

Public contact
Name of contact person
1st name Manabu
Middle name
Last name Musashi
Organization Tenshi College
Division name School of Nursing and Nutrition
Zip code 0650013
Address Higashi-ku, Kita-13 Higashi-3, Sapporo, Japan
TEL 011-741-1051
Homepage URL http://clinic.tenshidaigaku.net/
Email musashi@tenshi.ac.jp

Sponsor
Institute Tenshi College, School of Nursing and Nutrition, Department of Nutrition
Institute
Department

Funding Source
Organization Special Research Grant of Tenshi College
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tenshi College
Address Kita 13-jo Higashi 3-chome 1-30, Higashi-ku, Sapporo, Hokkaido
Tel 011-741-1051
Email kenkyurinri@tenshi.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 天使大学(北海道) Tenshi College (Hokkaido)

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 27 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 No longer recruiting
Date of protocol fixation
2011 Year 02 Month 01 Day
Date of IRB
2011 Year 04 Month 01 Day
Anticipated trial start date
2018 Year 06 Month 03 Day
Last follow-up date
2019 Year 10 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 27 Day
Last modified on
2019 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012541

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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