UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001237 |
|---|---|
| Receipt number | R000001421 |
| Scientific Title | A randomized comprison study of the psychosomatic effects of brown rice diet compareed with standard (white rice) diet in healthy lactating women, by comprehensive gene expression analysis. |
| Date of disclosure of the study information | 2008/07/09 |
| Last modified on | 2010/01/13 14:00:37 |
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Basic information
Public title
A randomized comprison study of the psychosomatic effects of brown rice diet compareed with standard (white rice) diet in healthy lactating women, by comprehensive gene expression analysis.
Acronym
A randomized comprison study of the psychosomatic effects of brown rice diet compareed with standard (white rice) diet in healthy lactating women, by comprehensive gene expression analysis.
Scientific Title
A randomized comprison study of the psychosomatic effects of brown rice diet compareed with standard (white rice) diet in healthy lactating women, by comprehensive gene expression analysis.
Scientific Title:Acronym
A randomized comprison study of the psychosomatic effects of brown rice diet compareed with standard (white rice) diet in healthy lactating women, by comprehensive gene expression analysis.
Region
| Japan |
Condition
Condition
Healthy woman who is at lactation
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate that brown rice exerts beneficial effects on psychosomatic health an analysis of change in gene,compared to white rice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Gene expression changes will be comprehensively analyzed before and after 4-weeks intervention. Furthermore, Lactoferrin, s-IgA and polyamine in milk as immunological aspect, NK cell activity, blood cell profiling, cortisol, IGF-1, MHPG, salivary amylase, s-IgA and oxidation/reduction potential as psychological aspect will be measured.
Key secondary outcomes
Changes in emotion and health by 4-weeks intervention will be assessed by Profile of mood states, the Subjective Well-being inventory and clinical laboratory profiles (hepatic and renal function).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intervention group will take brown rice as every staple diet for 4 weeks.
Interventions/Control_2
Control group will take white rice as every staple diet for 4 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1)Healthy women between 2 to 10mo. postpartum
2)Breastfeed routinely
3)Full-term delivery
Key exclusion criteria
1) Medication known to interfere with lactation
2) Extremely unbalanced diets
3) Intake of supplements and/or vitamins 1 week before the study until end of sampling.
4)Pre-germinated brown rice diet
5)Resumption of menstruation
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumie Murai |
Organization
University of Tsukuba
Division name
Graduate school of comprehensive human sciences
Zip code
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575, Japan
TEL
029-853-3439
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Hayashi |
Organization
Foundation for Advancement of International Science
Division name
Bio-Laboratory
Zip code
Address
586-9 Akatsuka-Ushigafuchi, Tsukuba, Ibaraki, 305-0062,Japan
TEL
029-836-6830
Homepage URL
hayashi@fais.or.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
FDN Advancement INT SCI
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
FDN Advancement INT SCI
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
| 2008 | Year | 07 | Month | 09 | 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
Completed
Date of protocol fixation
| 2008 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 07 | Month | 09 | Day |
Last modified on
| 2010 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001421
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