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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026356
Receipt No. 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

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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
Email 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
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030279

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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