UMIN-CTR Clinical Trial

Basic information
Public title	Physiological effects test by continuous intake of alcohol
Acronym	Physiological effects test by continuous intake of alcohol
Scientific Title	Physiological effects test by continuous intake of alcohol
Scientific Title:Acronym	Physiological effects test by continuous intake of alcohol
Region	Japan

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

Objectives
Narrative objectives1	Examining the effect of continuous intake of a small amount of alcohol on physiological fluctuations in healthy adult male and female 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	General Well-Being Schedule: GWBS
Key secondary outcomes	(Secondary outcomes) POMS2 shortened version, Pittsburgh Sleep Quality Index, serum free testosterone, serum DHEA-S, serum cortisol, plasma ACTH (Safety evaluation) Vital signs, physical measurements, blood biochemistry, adverse events

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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	4-weeks intake of the test food. Wash out (4 weeks) 4-weeks intake of the placebo food.
Interventions/Control_2	4-weeks intake of the placebo food. Wash out (4 weeks) 4-weeks intake of the test food.
Interventions/Control_3
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 and Female
Key inclusion criteria	1.Japanese male and female who are between 40 and 70 years old at the time of obtaining written consent. 2.Subject who has a General Well-Being Schedule: GWBS score of 70 points or less. 3.Subject who has received sufficient explanation of the purpose and content of the research, has the ability to consent.
Key exclusion criteria	1.Habitual drinkers (subject who drinks more than once a week on average in the last 3 months). 2.Subject who plans to have a health checkup and a human dock test during the test period. 3.Subject who is taking medication or under medical treatment due to serious illness. 4.Subject who is under exercise therapy or dietetic therapy. 5.Subject who may develop allergies (alcohol) due to the test foods. 6.Subject with current or history of alcohol and drug dependence. 7.Subject who is out of the hospital due to mental disorders (depression, etc.) or sleep disorders, or who has a history of mental illness in the past. 8.Subject with irregular life rhythms due to night shifts or shift work. 9.Subject with extremely irregular lifestyle habits such as eating and sleeping. 10.Subject who has an extremely unbalanced diet. 11.Subject who uses health foods, supplements, and medicines that affect alcohol metabolism. 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 is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 15.Subject who has difficulty observing records on various survey forms. 16.Subject who is judged as an inappropriate candidate according to the screening data. 17.Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size	40

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	Ethics Committees of Yoga Allergy Clinic
Address	4-32-16 Yoga,Setagaya-ku,Tokyo 158-0097 Japan
Tel	03-5491-4478
Email	jim@medipharma.co.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 07 Month 30 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	42
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 07 Month 02 Day
Date of IRB	2021 Year 07 Month 09 Day
Anticipated trial start date	2021 Year 08 Month 02 Day
Last follow-up date	2021 Year 12 Month 03 Day
Date of closure to data entry	2021 Year 12 Month 13 Day
Date trial data considered complete	2021 Year 12 Month 17 Day
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2021 Year 07 Month 29 Day
Last modified on	2022 Year 04 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051402