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.

UMIN ID: UMIN000001237

Registered date:09/07/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy woman who is at lactation
• Date of first enrollment: 2008/06/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: 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.
• Secondary Outcome: 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).

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Female
• Exclude 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

Related Information

• Primary Sponsor: University of Tsukuba
• Secondary Sponsor: FDN Advancement INT SCI
• Source(s) of Monetary Support: FDN Advancement INT SCI