NIPH Clinical Trials Search

UMIN ID: UMIN000001237

Registered date:09/07/2008

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.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedHealthy woman who is at lactation
Date of first enrollment2008/06/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Intervention group will take brown rice as every staple diet for 4 weeks. Control group will take white rice as every staple diet for 4 weeks.


Primary OutcomeGene 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.
Secondary OutcomeChanges 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).

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
Include criteria
Exclude criteria1) 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

Related Information


public contact
Name Takashi Hayashi
Address 586-9 Akatsuka-Ushigafuchi, Tsukuba, Ibaraki, 305-0062,Japan Japan
Telephone 029-836-6830
Affiliation Foundation for Advancement of International Science Bio-Laboratory
scientific contact
Name Fumie Murai
Address 1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575, Japan Japan
Telephone 029-853-3439
Affiliation University of Tsukuba Graduate school of comprehensive human sciences