Trial to confirm biological activities in humans after long term intake of polyamine-rich food -interventional tial using newly developed fermented soybeans "Natto"-

JRCT ID: jRCT1090220233

Registered date:18/12/2015

Basic Information

• Recruitment status: COMPLETED
• Health condition(s) or Problem(s) studied: Inhibition of aging-associated diseases
• Date of first enrollment: 22/12/2015
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intervention type:BEHAVIOUR
Name of intervention:Continuous intake of Natto, fermented soy bean products
Dose form / Japanese Medical Device Nomenclature:NOT APPLICABLE
Route of administration / Site of application:ORAL
Dose per administration:40 gram
more than 40 gram per day
40 gram
Dosing frequency / Frequency of use:BID
2
Planned duration of intervention:1 year
Intended dose regimen:volunteers in an object group are asked to eat 2 packs of "Natto" every day as much as possible.
detailes of teratment arms:Cancer patients are excluded from the study
Comparative intervention name:Control
Dose form / Japanese Medical Device Nomenclature:NOT APPLICABLE
Route of administration / Site of application:ORAL
Dose per administration:none
none
none
Dosing frequency / Frequency of use:OTHER, SPECIFY
none
Planned duration of intervention:1 year
Intended dose regimen:none

Outcome(s)

• Primary Outcome: Changes in blood polyamine levels. Changes of blood data induced by polyamine, sucha as LFA-1(lymphocyte function associated antigen 1) expression on immune cells, blastoid transformation of lymphocyte by con-A, HDL, LDL, and CRP.
• Secondary Outcome: event of aging-associated diseases

Key inclusion & exclusion criteria

• Age minimum: >= 40month old
• Age maximum: <= 70age old
• Gender: Male
• Include criteria: Healthy volunteer
• Exclude criteria: soybean allergy, cancer patients

Related Information

• Source(s) of Monetary Support: Ministry of Agriculture, Forestry and Fisheries of Japan
• Secondary ID(s): JMA-IIA00233