UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028838
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute HUMA R&D CORP
Institute
Department

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
URL(English) https://upload.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


Contact us.