UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028838
Receipt number R000033006
Scientific Title Verification test on improvement in a liver disorder marker and a cholesterol lowering effect
Date of disclosure of the study information 2017/09/05
Last modified on 2018/03/01 08:36:02

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Basic information

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

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

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


Assessment

Primary outcomes

1.ALT
2.LDL-C

Key secondary outcomes

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


Base

Study type

Interventional


Study design

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


Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

HUMA R&D CORP

Institute

Department

Personal name



Funding Source

Organization

Asahi Group Holdings,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


Address


Tel


Email



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

2017 Year 09 Month 05 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

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name