UMIN-CTR Clinical Trial

Public title

Verification test on improvement in a liver disorder marker and a cholesterol lowering effect

Acronym

Verification test on improvement in a liver disorder marker and a cholesterol lowering effect

Scientific Title

Verification test on improvement in a liver disorder marker and a cholesterol lowering effect

Scientific Title:Acronym

Verification test on improvement in a liver disorder marker and a cholesterol lowering effect

Region

Japan

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine an influence of a test food product on improvement in a liver disorder marker and a cholesterol lowering effect by selecting healthy males and females aged 20 and over, below 65 who are not affected with a disease as subjects and assigning them to take the test food product for 12 weeks on a continuous basis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II

Primary outcomes

1.ALT
2.LDL-C

Key secondary outcomes

1.GAMMA-GTP
2.AST
3.TC
4.HDL-C
5.TG

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

12-week intake of the test food

Interventions/Control_2

12-week intake of the test food

Interventions/Control_3

12-week intake of the placebo food

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

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1.Subjects giving written informed consent
2. Age: 20 and over, below 65 Males and females with Japanese nationality who are not affected with a disease
3. Persons who are able to drink 1 can of beverage per day for 12 weeks on a continuous basis
4.As liver function markers, ALT: 50 and below, GAMMA-GTP: 100 and below, AST: 50 or below
5. LDL-C: 120 to 159 mg/dl
6.Average pure alcohol intake per day for males: below 60 g, females: below 40 g

Key exclusion criteria

1. Currently in treatment with medication or seeing a doctor for treatment
2. Previous history of severe liver disorder (viral hepatitis, drug-induced liver injury, cirrhosis) or currently suspected to have liver disorder (a positive test result on hepatitis screening, etc.)
3. Previous history of liver disorder or severe disorder related to kidney, endocrine, cardiovascular system, gastrointestine, lung, blood, metabolism, or currently presence of complications
4. Previous history of a drug allergy and/or food allergy
5. Regular intake of a health food product or supplement possibly influencing the liver function and lowering cholesterol
6. Regular intake of medication possibly influencing the liver function and lowering cholesterol
7.Extreme faddiness
8. Extremely irregular lifestyle such as a dietary pattern and a sleeping pattern
9.Presence or previous history of mental disorder (depression, etc.)
10. A large volume of alcohol intake (average pure alcohol intake per day for males: 60 g or over, females: 40 g or over)
11.11) Current participation in another clinical trial or participation in another clinical trial within the last three months
12.Determined by the investigator to be unsuitable for enrollment in this study

Target sample size

69

Name of lead principal investigator

1st name
Middle name
Last name	Ochitani Daisuke

Organization

HUMA R&D CORP

Division name

Clinical Development Division

Zip code

Address

Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan

TEL

81-3-3431-1260

Email

ochitani@huma-c.co.jp

Name of contact person

1st name
Middle name
Last name	Ochitani Daisuke

Organization

HUMA R&D CORP

Division name

Clinical Development Division

Zip code

Address

Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan

TEL

81-3-3431-1260

Homepage URL

Email

ochitani@huma-c.co.jp

Institute

HUMA R&D CORP

Institute

Department

Personal name

Organization

Asahi Group Holdings,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

Date of disclosure of the study information

2017

Year

09

Month

05

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

2017

Year

07

Month

14

Day

Date of IRB

Anticipated trial start date

2017

Year

08

Month

30

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

08

Month

25

Day

Last modified on

2018

Year

03

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033006