UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044156 |
|---|---|
| Receipt number | R000050420 |
| Scientific Title | Survey of physiological effects after drinking alcohol |
| Date of disclosure of the study information | 2021/05/10 |
| Last modified on | 2022/08/08 10:14:44 |
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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
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
ochitani@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050420
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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