UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A verification study on effects of alcohol metabolism improvement: A randomized double-blind crossover trial
Title of the study (Brief title)	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	Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
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	Naoko SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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