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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001237
Receipt No. 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

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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
Email

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
Email hayashi@fais.or.jp

Sponsor
Institute University of Tsukuba
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001421

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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