UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026356 |
|---|---|
| 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 |
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Basic information
Public title
A verification study on effects of alcohol metabolism improvement: A randomized double-blind crossover trial
Acronym
A verification study on effects of alcohol metabolism improvement
Scientific Title
A verification study on effects of alcohol metabolism improvement: A randomized double-blind crossover trial
Scientific Title:Acronym
A verification study on effects of alcohol metabolism improvement
Region
| Japan |
Condition
Condition
Healthy Japanese adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects on alcohol metabolism improvement by test food
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
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)
Key secondary outcomes
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)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
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
Interventions/Control_2
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
Interventions/Control_3
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
Interventions/Control_4
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
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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
Key exclusion criteria
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
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
I-ne co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Seishin-kai Medical Association Inc, Takara Medical Clinic.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
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)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 01 | Day |
Last modified on
| 2018 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030279
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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