Unique ID issued by UMIN | UMIN000026356 |
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Receipt number | R000030279 |
Scientific Title | A verification study on effects of alcohol metabolism improvement: A randomized double-blind crossover trial |
Date of disclosure of the study information | 2017/03/01 |
Last modified on | 2018/05/11 11:03:11 |
A verification study on effects of alcohol metabolism improvement: A randomized double-blind crossover trial
A verification study on effects of alcohol metabolism improvement
A verification study on effects of alcohol metabolism improvement: A randomized double-blind crossover trial
A verification study on effects of alcohol metabolism improvement
Japan |
Healthy Japanese adults
Not applicable | Adult |
Others
NO
To verify the effects on alcohol metabolism improvement by test food
Efficacy
Confirmatory
Pragmatic
1. Blood ethanol concentration
*Take blood samples before drinking alcohol and at 30, 60, 120, and 180 minutes after
*Implement after each single-dose (total 4 times)
1. Blood acetaldehyde concentration
* Take blood samples before drinking alcohol and at 30, 60, 120, and 180 minutes after
*Implement after each single-dose (total 4 times)
2. Questionnaire of subjective symptoms (The Likert scale method)
*Fill in the questionnaire 180 minutes after drinking alcohol
*Implement after each single-dose (total 4 times)
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
4
Treatment
Food |
I. Active beverage
II. Positive control beverage 1
III. Positive control beverage 2
IV. Placebo beverage
*The intervention sequence is I-IV, and each beverage is single dose
*Refrigerate the test beverage before drinking and drink (100 mL) it 30 minutes before drink alcohol
*Washout period is for 1 week and more
I. Positive control beverage 1
II. Placebo beverage
III. Active beverage
IV. Positive control beverage 2
*The intervention sequence is I-IV, and each beverage is single dose
*Refrigerate the test beverage before drinking and drink (100 mL) it 30 minutes before drink alcohol
*Washout period is for 1 week and more
I. Positive control beverage 2
II. Active beverage
III. Placebo beverage
IV. Positive control beverage 1
*The intervention sequence is I-IV, and each beverage is single dose
*Refrigerate the test beverage before drinking and drink (100 mL) it 30 minutes before drink alcohol
*Washout period is for 1 week and more
I. Placebo beverage
II. Positive control beverage 2
III. Positive control beverage 1
IV. Active beverage
*The intervention sequence is I-IV, and each beverage is single dose
*Refrigerate the test beverage before drinking and drink (100 mL) it 30 minutes before drink alcohol
*Washout period is for 1 week and more
20 | years-old | <= |
Not applicable |
Male and Female
1. Healthy Japanese adults
2. Those who is able to drink whisky (alcohol: 18%)
3. Those who have a low tolerance of alcohol
4. Those who are considered as appropriate for the study by the physician
5. The area under the blood ethanol concentration-time curve (TAUC) is relatively large
1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction
2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases
3. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily
4. Currently taking medicines and/or herbal medicines
5. Those who are allergic to medicines and/or the test food related products
6. Those who are pregnant, breast-feeding, and plan to become a pregnant
7. Those who had participated another clinical test for three months when you signed the informed consent form for this trial
8. Others considered as inappropriate for the study by the physician
15
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
kazu@orthomedico.jp
1st name | |
Middle name | |
Last name | Naoko SUZUKI |
ORTHOMEDICO Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
I-ne co., Ltd.
Profit organization
Seishin-kai Medical Association Inc, Takara Medical Clinic.
NO
医療法人社団 盛心会 タカラクリニック (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)
2017 | Year | 03 | Month | 01 | Day |
Published
Nakajima N, Toida E, Akaoka K, Yokogawa S, Suzuki N, Fujioka R, Takara T. Effects of a Beverage Containing Powder of Antrodia cinnamomea mycelium and Fermented Grain Extracts on Improving Alcohol Metabolism-A Randomized, Double-blinded, Placebo-controlled, Crossover Trial-. Jpn Pharmacol Ther. 2018; 46(3): 363-373.
Completed
2017 | Year | 02 | Month | 28 | Day |
2017 | Year | 03 | Month | 02 | Day |
2017 | Year | 03 | Month | 01 | Day |
2018 | Year | 05 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030279
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