UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044495 |
|---|---|
| Receipt number | 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 | 2022/03/30 11:41:35 |
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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
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
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
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
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
100
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
| 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
| 2022 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050832
