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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000463
Receipt No. R000000527
Scientific Title A randomized comparison study of the immunological and psychosomatic effects of brown rice diet compared with standard diet (white rice) in healthy lactating women.
Date of disclosure of the study information 2006/08/05
Last modified on 2007/03/06

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Basic information
Public title A randomized comparison study of the immunological and psychosomatic effects of brown rice diet compared with standard diet (white rice) in healthy lactating women.
Acronym A randomized comparison study of the immunological and psychosomatic effects of brown rice diet compared with standard diet (white rice) in healthy lactating women.
Scientific Title A randomized comparison study of the immunological and psychosomatic effects of brown rice diet compared with standard diet (white rice) in healthy lactating women.
Scientific Title:Acronym A randomized comparison study of the immunological and psychosomatic effects of brown rice diet compared with standard diet (white rice) in healthy lactating women.
Region
Japan

Condition
Condition Healthy lactating women
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate that brown rice exerts beneficial effects on psychosomatic health in terms of the immunological factor in the milk, 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 Before and After 2-weeks intervention, Lactoferrin, s-IgA, nucleotides and polyamine in milk as immunological aspect, and Amylase in saliva as psychological aspect will be measured.
Key secondary outcomes Changes in emotion and health by 2-weeks intervention will be assessed by Profile of mood states and General health questionnaire.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
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 2 weeks.
Interventions/Control_2 Control group will take white rice as every staple diet for 2 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 3 to 12 mo. postpartum.
2)Breastfeed routinely
3)Full-term delivery
4)Subjects are not receiving any medication known to interfere with lactation.
5)No extreme unbalanced diets
6)Subjects who can stop taking their supplements & vitamins 1 week before the study until end sampling.
7)Subjects who can collect sample between 12:00 & 16:00, using manual breast pump.
Key exclusion criteria N/A
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 science
Zip code
Address 1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8577, Japan
TEL 029-853-3439
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shigeko Sakamoto
Organization Foundation for Advancement of International Science
Division name Bio-Laboratory
Zip code
Address 586-9 Akatsuka-Ushigafuchi, Tsukuba, 305-0062, Japan
TEL 029-836-6830
Homepage URL
Email sakamoto@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
2006 Year 08 Month 05 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
2006 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2006 Year 06 Month 01 Day
Last follow-up date
2007 Year 03 Month 01 Day
Date of closure to data entry
2007 Year 03 Month 01 Day
Date trial data considered complete
2007 Year 03 Month 01 Day
Date analysis concluded
2007 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 08 Month 04 Day
Last modified on
2007 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000527

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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