Verification test of anti-stress effects in humans by a single time intake of Asteraceous plant extracts -Main test-

UMIN ID: UMIN000019839

Registered date:18/11/2015

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: N/A
• Date of first enrollment: 2015/11/18
• Target sample size: 160
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Beverage blended with Asteraceous plant extracts(20mg)
Beverage blended with Asteraceous plant extracts(200mg)
Theanine-blended beverage
Beverage which contains neither Asteraceous plant extracts nor theanine

Outcome(s)

• Primary Outcome: cortisol in saliva, free-MHPG( final metabolites of central noradrenaline), s-IgA density and VAS
• Secondary Outcome: heartbeat, blood pressure

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 30years-old
• Gender: Male and Female
• Exclude criteria: (1) Those who take health assistant foods or supplements on a daily basis (2) Those who take medicaments or healthy foods regularly, which could influence the test results (3) Those who are receiving a medical treatment which might affect test results (psychosomatic medicine/neurology/neuropathic internal medicine etc.) (4) Those who have a medical history of allergic diseases (seasonal allergic rhinitis= pollinosis/chronic allergic rhinitis/asthma/atopic dermatitis/allergic conjunctivitis) (5) Those who have bleeding teeth or any other oral cavity problems (6) Heavy drinkers/ Heavy smokers and those who drink caffeinated drinks in large quantities (7) Those whose eating habits are extremely irregular/ Night-shift workers/ Those who work in shifts (8) Those who are judged as inadequate to participate this study by doctors in charge

Related Information

• Primary Sponsor: Kurume University
• Secondary Sponsor: Beppu University/ Kyoto Tachibana University
• Source(s) of Monetary Support: Suntory Beverage & Food Limited