UMIN ID: UMIN000019841
Registered date:18/11/2015
Verification test of anti-stress effects in humans by a single time intake of Asteraceous plant extracts -Preliminary test-
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 | 10 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Beverage blended with Asteraceous plant extracts(200mg) -> washout period -> Beverage which contains neither Asteraceous plant extracts nor theanine Beverage which contains neither Asteraceous plant extracts nor theanine -> washout period -> Beverage blended with Asteraceous plant extracts(200mg) |
Outcome(s)
| Primary Outcome | salivary levels of cortisol, free-MHPG and s-IgA, and the score of VAS at baseline, and 15 and 30 minutes after sample drinking. |
|---|---|
| Secondary Outcome | heartbeat, blood pressure |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 30years-old |
| Gender | Male and Female |
| Include criteria | |
| 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 |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hisayoshi Okamura |
| Address | 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan Japan |
| Telephone | 0942-31-7581 |
| okamura_hisayoshi@med.kurume-u.ac.jp | |
| Affiliation | Kurume University Cognitive and Molecular Research Institute of Brain Diseases |
| scientific contact | |
| Name | Akira Tsuda |
| Address | 1635 Mii-machi, Kurume-shi, Fukuoka-ken 839-8502 Japan Japan |
| Telephone | 0942-43-4411 |
| tsuda_akira@kurume-u.ac.jp | |
| Affiliation | Kurume University Department of Psychology |