UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006353 |
|---|---|
| Receipt number | R000007540 |
| Scientific Title | Randomized controlled trial of effects of long-term consumption of milk and dairy products in addition to dietary guidance on metabolic syndrome |
| Date of disclosure of the study information | 2011/09/15 |
| Last modified on | 2015/01/20 17:44:04 |
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Basic information
Public title
Randomized controlled trial of effects of long-term consumption of milk and dairy products in addition to dietary guidance on metabolic syndrome
Acronym
Randomized controlled trial of long-term consumption of milk and dairy products
Scientific Title
Randomized controlled trial of effects of long-term consumption of milk and dairy products in addition to dietary guidance on metabolic syndrome
Scientific Title:Acronym
Randomized controlled trial of long-term consumption of milk and dairy products
Region
| Japan |
Condition
Condition
Metabolic Syndrome
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effects of long-term consumption of milk and dairy products in addition to dietary guidance for 24 weeks on metabolic syndrome. To explore effects of milk and dairy products on change in laboratory markers, compliance with dietary guidance and intakes of milk and dairy products.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Weight, Waist, Body Fat Percentage,
Fasting Blood Sugar, HbA1c,
Total Cholesterol, LDL Cholesterol, HDL cholesterol, Fasting Triglyceride,
SBP, and DBP, evaluated at the time of registration, 3rd month and 6th month
Key secondary outcomes
Food frequency questionnaire and questionnaire on exercise and sleeping habit, evaluated at the time of registration, 3rd month and 6th month
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Dietary guidance for 24 weeks
Interventions/Control_2
Long-term consumption of milk and dairy products in addition to dietary guidance for 24 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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
1.BMI >= 25kg/m2
2.Waist >= 85cm
3.Total Cholesterol >= 200mg/dL(nearly equal LDL Cholesterol >= 120mg/dL)
4.Fasting triglyceride >= 150mg/dL
5.Fasting Blood Sugar >= 100mg/dL
6.SBP >= 130mmHg or DBP >= 85mmHg
7.Person who can consume dairy products for 24 weeks.
8.Person who takes antihypertensive drug and/or antihyperlipidemic drug is not excluded on condition that such person has to be reviewed by an investigator.
Key exclusion criteria
1.Smokers
2.Person who suffers health problem from consumption of dairy products, i.e. milk allergy
3.Person whose clinical laboratory test results are significantly out of standard value, and an investigator determined that he is required to take treatment.
4.Person who participated another clinical investigation or trial within 3 months from the start date of this study.
5.Person who has critical disease history such as cardiac disease, cerebrovascular disease, kidney disease and/or diabetic disease.
6.With other factors, an investigator determines that a person is unfit to participate the study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Ohashi, Ph.D. |
Organization
UNIVERSITY OF TOKYO
Division name
Department of Biostatistics, School of Public Health
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
TEL
03-5841-3518
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aturou Koga |
Organization
Hubit genomix, Inc.
Division name
Business Promotion Unit
Zip code
Address
Tukiji-Ogawa Building 3F, 7-10-2 Tukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-5148-3992
Homepage URL
akoga@hubitgenomix.com
Sponsor or person
Institute
Japan Dairy Association
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
株式会社CSK（東京都、愛知県、大阪府）CSK Corporation(Tokyo, Aichi, Osaka)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jnsv/60/5/60_305/_pdf
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
| 2010 | Year | 10 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 15 | Day |
Last modified on
| 2015 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007540
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
