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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044495
Receipt No. R000050832
Scientific Title Effect of 12-week continuous ingestion of the supplement on liver function.-A placebo-controlled, randomized, double-blind, parallel-group comparative study-
Date of disclosure of the study information 2021/06/11
Last modified on 2021/06/10

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Basic information
Public title Effect of 12-week continuous ingestion of the supplement on liver function.-A placebo-controlled, randomized, double-blind, parallel-group comparative study-
Acronym Effect of 12-week continuous ingestion of the supplement on liver function.
Scientific Title Effect of 12-week continuous ingestion of the supplement on liver function.-A placebo-controlled, randomized, double-blind, parallel-group comparative study-
Scientific Title:Acronym Effect of 12-week continuous ingestion of the supplement on liver function.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of 12 weeks continuous ingestion of trial supplement on liver function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ALT : Alanine Aminotransferase
Key secondary outcomes AST : Aspartate Aminotransferase
Gamma-GTP : Gamma-Glutamic Transpeptidase

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
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Test food(Intake period:12 weeks)
Interventions/Control_2 Control food (Intake period:12 weeks)
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1.Male and female aged between 20 to 64 years old at the time of informed consent.
2.Subjects whose BMI is between the range of 25 and 29 kg/m2.
3.Subjects whose ALT is between 31 to 50 U/+-10% at the time of the screening test 1.
4.Subjects whose ALT is between 31 to 50 U/L+-10% at the time of the screening test 2.
5.Subjects who agree to participate in the study on one's own will.
Key exclusion criteria 1.Subjects whose AST is above 50 U/L and/or Gamma-GTP above 100 U/L at the time of the screening test 2.
2.Subjects who have history of liver disease, or is currently under medical treatment of the liver disease.
3.Subjects who are suffering or suffered from serious disease in the past.
4.Subjects who have average intake of alcohol more than 59 g per week.
5.Subjects who have food allergies or who may be allergic to the test food.
6.Subjects who are taking drugs and quasi-drugs that may affect the current study.
7.Subjects who are taking health foods that may affect the current study.
8.Subjects who cannot stop taking the drugs, quasi-drugs and health foods during the study period (after agreeing to the informed consent until the end of the 12-week test food ingestion period).
9.Subjects who have extremely irregular lifestyles.
10.Subjects who are currently participating in other studies, or participating in other studies within the past 3 months from the time of the informed consent.
11.Subjects who are planning to participate in other studies during this study.
12.Subjects who are pregnant, or planning to become pregnant or breastfeed during this study.
13.Subjects who are judged as unsuitable participant for the study by the doctor and investigator.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kei
Middle name
Last name Yui
Organization FANCL Corporation
Division name Research Institute, Health science research center
Zip code 244-0806
Address 12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL 045-820-3755
Email ke-yui@fancl.co.jp

Public contact
Name of contact person
1st name Eiji
Middle name
Last name Yoshikawa
Organization KSO Corporation
Division name Sales department
Zip code 105-0023
Address 1-9-7 Shibaura, Minato-ku, Tokyo
TEL 03-3452-7733
Homepage URL
Email eigyou27@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization FANCL Corporation
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 Ethical Committee of Nihonbashi Cardiology Clinic
Address Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel 03-5641-4133
Email niho-jimucho@well-sleep.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 医療法人財団健康睡眠会 日本橋循環器科クリニック

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 11 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 Preinitiation
Date of protocol fixation
2021 Year 05 Month 11 Day
Date of IRB
2021 Year 04 Month 06 Day
Anticipated trial start date
2021 Year 06 Month 12 Day
Last follow-up date
2021 Year 11 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 06 Month 10 Day
Last modified on
2021 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050832

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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