UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044156
Receipt No. R000050420
Scientific Title Survey of physiological effects after drinking alcohol
Date of disclosure of the study information 2021/05/10
Last modified on 2021/06/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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 No longer recruiting
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 05 Month 10 Day
Last modified on
2021 Year 06 Month 14 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.