Unique ID issued by UMIN | UMIN000036762 |
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Receipt number | R000041878 |
Scientific Title | Examination of the influence that continued intake of rosemary extract exerts stress and cognitive function from stress |
Date of disclosure of the study information | 2019/05/27 |
Last modified on | 2020/09/30 11:01:27 |
Examination of the influence that continued intake of rosemary extract exerts stress and cognitive function from stress
Examination of the influence that continued intake of rosemary extract exerts stress and cognitive function from stress
Examination of the influence that continued intake of rosemary extract exerts stress and cognitive function from stress
Examination of the influence that continued intake of rosemary extract exerts stress and cognitive function from stress
Japan |
Healthy subjects
Adult |
Others
NO
To investigate the effects of continuous intake of rosemary extract for 4 weeks on stress and cognitive function caused by stress in healthy Japanese men aged 20 to 65 years old.
Safety,Efficacy
POMS II (all items version),Cognitrax
VAS questionnaire(6 items),Blood catecholamine 3 fraction,d-ROM,BDNF,Salivary cortisol
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
4-week intake of the test food
4-week intake of the placebo food
20 | years-old | <= |
65 | years-old | > |
Male
1)Japanese male and aged between 20 and 65 years old at the time of the informed.
2)Subject who feels fatigue and routinely.
3)Subject who is Beck Depression Inventory(BDI)less than 21 points.
4)Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
1)Subject who is taking medication or under medical treatment.
2)Subject who is under exercise therapy or dietetic therapy.
3)Subject who has an allergy for test food.
4)Subject who has or had a history of either medicine or alcohol dependence syndrome.
5)Subject who has or had a history of mental illness (depression) or sleep disturbance.
6)Subject who is on a night-shift or is a shift worker.
7)Subject who currently have a smoking habit.
8)Subject whose lifestyle is extremely irregular.
9)Subject who has an unbalanced diet.
10)Subject who regularly drink energy drinks.
11)Subject who has current disease or history of diabetes, liver disease (hepatitis), kidney disease, serious disease such as heart disease, thyroid disease, adrenal disease, other metabolic diseases.
12)Subject who use stress, health foods, supplements, and medicines that affect cognitive function.
13)Subject who regularly take commercially available sleep improving drugs and sleep inducing agents.
14)Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study.
15)Subject who has blood drawn 200mL within the past 1 months or 400mL within the past 3 months from the day of the consent acquisition.
16)Subject who can't keep the daily records.
17)Subject who is judged as an inappropriate candidate according to the screening data.
18)Subject who is considered as an inappropriate candidate by the doctor in charge.
42
1st name | Kazuhiro |
Middle name | |
Last name | Ogura |
S&B FOODS INC.
Development and manufacturing group-Central Research Institute-Technology Research and Development Unit
174-8651
38-8, Miyamoto-cho Itabashi-ku, Tokyo
03-3558-5531
kazuhiro_ogura@sbfoods.co.jp
1st name | Daisuke |
Middle name | |
Last name | Ochitani |
HUMA R&D CORP
Clinical Development Division
108-0014
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
03-3431-1260
ochitani@huma-rd.co.jp
HUMA R&D CORP
S&B FOODS INC.
Profit organization
Ethics Committees of Nihonbashi Egawa Clinic
2F Kotobuki Build. 1-27-12 Yaesu Chuo-ku, Tokyo 103-0028 Japan
03-5204-0311
jim@medipharma.co.jp
NO
2019 | Year | 05 | Month | 27 | Day |
Unpublished
Completed
2019 | Year | 04 | Month | 03 | Day |
2019 | Year | 04 | Month | 15 | Day |
2019 | Year | 05 | Month | 27 | Day |
2019 | Year | 07 | Month | 05 | Day |
2019 | Year | 08 | Month | 15 | Day |
2019 | Year | 08 | Month | 30 | Day |
2020 | Year | 09 | Month | 30 | Day |
2019 | Year | 05 | Month | 16 | Day |
2020 | Year | 09 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041878
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