UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020171 |
|---|---|
| Receipt number | R000023304 |
| Scientific Title | Short-term intake of a Japanese-style healthy lunch menu contributes to prevention and/or improvement in metabolic syndrome among middle-aged men: a non-randomized controlled trial |
| Date of disclosure of the study information | 2015/12/11 |
| Last modified on | 2015/12/17 14:01:07 |
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Basic information
Public title
Short-term intake of a Japanese-style healthy lunch menu contributes to prevention and/or improvement in metabolic syndrome among middle-aged men: a non-randomized controlled trial
Acronym
Healthy lunch and metabolic syndrome
Scientific Title
Short-term intake of a Japanese-style healthy lunch menu contributes to prevention and/or improvement in metabolic syndrome among middle-aged men: a non-randomized controlled trial
Scientific Title:Acronym
Healthy lunch and metabolic syndrome
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Healthy lunch consumed at a workplace cafeteria aimed to prevent and/or improve metabolic syndrome among middle-aged men.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of blood pressure and blood (glucose, hemoglobin A1c, triacylglycerol, free fatty acid, T-Chol, HDL-Chol, LDL-Chol, active-ghrelin, desacyl-grelin, Leptin) after 3 months
Key secondary outcomes
Change of anthropometry (height, weight, body fat percentage, BMI, waist circumference) and food intake after 3 months
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Healthy lunch (3 months)
Interventions/Control_2
Control
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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
Obtained written informed consent from the men before the participation
Key exclusion criteria
Those who felt this study was inconvenient to everyday life.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiko Kuwano |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
Address
52-1 Yada, Suruga-Ward, Shizuoka-City 422-8526, Japan
TEL
0542645513
kuwano@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiko Kuwano |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
Address
52-1 Yada, Suruga-Ward, Shizuoka-City 422-8526, Japan
TEL
0542645513
Homepage URL
kuwano@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
University of Shizuoka
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 12 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2008 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | 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
| 2015 | Year | 12 | Month | 11 | Day |
Last modified on
| 2015 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023304
