UMIN-CTR Clinical Trial

Public title

A pilot study on the inhibition of blood alcohol concentration increase after ingestion of peptides.

Acronym

A pilot study on the inhibition of blood alcohol concentration increase after ingestion of peptides.

Scientific Title

A pilot study on the inhibition of blood alcohol concentration increase after ingestion of peptides.

Scientific Title:Acronym

A pilot study on the inhibition of blood alcohol concentration increase after ingestion of peptides.

Region

Japan

Condition

Not applicable

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

To confirm the effect of peptides on the blood alcohol concentration after intake of alcohol.

Basic objectives2

Pharmacokinetics

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Efficacy : Area under the curve of blood alcohol level.
Safety : Adverse effects

Key secondary outcomes

Efficacy : Area under the curve of acetaldehyde level. Area under the curve of expired gas alcohol level. VAS.
Safety : Adverse events

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Subjects take peptides with 30g of alcohol for one day at the dosage of 3g/human for one time.

Interventions/Control_2

Subjects take 30g of alcohol for one day for one time.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

50

years-old

>

Gender

Male

Key inclusion criteria

1)Healthy males aged 20 or more and less than 50 years-old.
2)Subjects who can drink alcohol effortlessly.
3)Subjects who can make self-judgment and are voluntarily giving written informed consent.

Key exclusion criteria

1)Subjects whose systolic blood pressure is less than 90mmHg.
2)Subjects whose BMI is less than 20.0 and 23 or more.
3)Subjects who can't drink alcohol.
4)Subjects who are positive to alcohol patch test.
5)Subjects who drink alcohol a lot and smoke a lot.
6)Subjects who have an irregular sleep cycle, work shift or work on midnight shift
7)Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results.
8)Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks.
9)Subjects who are positive to hepatitis virus B, hepatitis virus C, HIV or human T-cell leukemia virus
10)Subjects who have allergic reaction to drug medicine and food.
11)Subject who are applicable to one of the below.
a)Subject who are contracting heart, liver or kidney disease including the case of complicating disease.
b)Subjects with a previous history of cardiovascular disease.
c)Subjects who are contracting diabetes.
12)Subjects who donated 200 mL of blood and/or blood components within four weeks prior to the current study.
13)Subjects whose blood was collected more than 400 mL within the last twelve weeks.
14)Subjects whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added.
15)Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.

Target sample size

12

Name of lead principal investigator

1st name
Middle name
Last name	Norihito Murayama

Organization

Suntory Global Innovation Center Ltd.

Division name

Innovation Development Department

Zip code

Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan

TEL

050-3182-0588

Email

Norihito_Murayama@suntory.co.jp

Name of contact person

1st name
Middle name
Last name	Hiroshi Watanabe

Organization

Suntory Global Innovation Center Ltd.

Division name

Innovation Development Department

Zip code

Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan

TEL

050-3182-0593

Homepage URL

Email

H_Watanabe@suntory.co.jp

Institute

Suntory Global Innovation Center Ltd.

Institute

Department

Personal name

Organization

Suntory Global Innovation Center Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

チヨダパラメディカルケアクリニック（東京都）

Date of disclosure of the study information

2015

Year

11

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

10

Month

21

Day

Date of IRB

Anticipated trial start date

2015

Year

11

Month

13

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

10

Month

07

Day

Last modified on

2016

Year

01

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022273