UMIN-CTR Clinical Trial

Basic information
Public title	Survey of physiological effects after drinking alcohol
Acronym	Survey of physiological effects after drinking alcohol
Scientific Title	Survey of physiological effects after drinking alcohol
Scientific Title:Acronym	Survey of physiological effects after drinking alcohol
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The transient effects of consuming beverages with different alcohol content on the body will be investigated in healthy adult males between the ages of 40 and 70.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum free testosterone, Drunkenness VAS Questionnaire
Key secondary outcomes	(Secondary outcomes) Serum testosterone, serum DHEA-S, serum cortisol, plasma ACTH, blood lactate, blood pyruvate, serum creatinine, plasma glucose, serum uric acid, serum TG, serum amino acids, blood acetic acid, breath alcohol content. (Safety evaluation) Vital signs, physical measurements, adverse events.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Take test food A on the day of the test. Wash out (2 weeks or more) Take placebo food on the day of the test. Wash out (2 weeks or more) Take test food B on the day of the test.
Interventions/Control_2	Take test food B on the day of the test. Wash out (2 weeks or more) Take test food A on the day of the test. Wash out (2 weeks or more) Take placebo food on the day of the test.
Interventions/Control_3	Take placebo food on the day of the test. Wash out (2 weeks or more) Take test food B on the day of the test. Wash out (2 weeks or more) Take test food A on the day of the test.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	70 years-old >
Gender	Male
Key inclusion criteria	1.Japanese males who are between 40 and 70 years old at the time of obtaining written consent. 2.Subject with serum free testosterone levels below 11.8 pg/ml. 3.Subject who can drink moderate amounts of alcohol (about 500ml of beer). 4.Subject who has received sufficient explanation of the purpose and content of the research, has the ability to consent.
Key exclusion criteria	1.Subject who has been diagnosed as an alcoholic by a physician. 2.Subject who is taking medication or under medical treatment due to serious illness. 3.Subject who is under exercise therapy or dietetic therapy. 4.Subject who may develop allergies due to the test foods. 5.Subject with current or history of drug dependence. 6.Subject who is out of the hospital due to mental disorders (depression, etc.) or sleep disorders, or who have a history of mental illness in the past. 7.Subject with irregular life rhythms due to night shifts or shift work. 8.Subject with extremely irregular lifestyle habits such as eating and sleeping. 9.Subject who has an extremely unbalanced diet. 10.Serious diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), renal disease, heart disease, thyroid disease, adrenal disease, and other serious current or past diseases such as metabolic disease those who have. 11.Subject who uses health foods, supplements, and medicines that affect male hormone. 12.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. 13.Subject who has blood collection or donation more than 200mL within the past 1 month or more than 400mL within the past 3 months from the day of the consent acquisition. 14.Subject who can't keep the daily records. 15.Subject who is judged as an inappropriate candidate according to the screening data. 16.Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size	36

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Public Relations Department
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Email	ochitani@huma-rd.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Public Relations Department
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	Asahi Quality & Innovations, Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	NISHI-UMEDA Clinic for Asian Medical Collaboration Clinical Research Institutional Review Board
Address	West Umeda Building 3F 3-3-45 Umeda Kita-ku Osaka Japan,530-0001
Tel	06-4797-5660
Email	jimukyoku@amc-clinc.jp

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

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	36
Results
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	2021 Year 04 Month 15 Day
Date of IRB	2021 Year 04 Month 22 Day
Anticipated trial start date	2021 Year 05 Month 11 Day
Last follow-up date	2021 Year 08 Month 26 Day
Date of closure to data entry	2021 Year 09 Month 07 Day
Date trial data considered complete	2021 Year 09 Month 21 Day
Date analysis concluded	2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2021 Year 05 Month 10 Day
Last modified on	2022 Year 08 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050420