UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045762 |
|---|---|
| Receipt number | R000052247 |
| Scientific Title | Effect of supplement on liver. -A placebo-controlled, randomized, double-blind, parallel-group comparative study- |
| Date of disclosure of the study information | 2022/10/31 |
| Last modified on | 2022/11/16 18:39:47 |
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Basic information
Public title
Effect of supplement on liver.
-A placebo-controlled, randomized, double-blind, parallel-group comparative study-
Acronym
Effect of supplement on liver.
Scientific Title
Effect of supplement on liver.
-A placebo-controlled, randomized, double-blind, parallel-group comparative study-
Scientific Title:Acronym
Effect of supplement on liver.
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 supplement on liver.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Liver fat content
Key secondary outcomes
ALT : Alanine Aminotransferase
AST : Aspartate Aminotransferase
Gamma-GT : Gamma-Glutamic Transpeptidase
Low Density Lipoprotein cholesterol
High Density Lipoprotein cholesterol
Triglyceride
Body Weight
Body Mass Index
Body Fat Percentage
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
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:24 weeks)
Interventions/Control_2
Control food (Intake period:24 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.Japanese male and female aged between 20 to 65 years old at the time of informed consent.
2.Subjects whose BMI is between 25.0 to 30.0 kg/m2.
3.Subjects who agreed to participate in the study on one's own will.
Key exclusion criteria
1.Subjects whose liver stiffness is more than 6.0 kPa.
2.Subjects who had liver disease, or have currently under medical treatment of the liver disease.
3.Subjects who are currently undergoing treatment for serious diseases.
4.Subjects who have average intake of alcohol more than 60 g/day by 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 regularly take health foods that may affect the current study.
8.Subjects who will not stop taking the drugs, quasi-drugs and health foods during the study period (after agreeing to the informed consent until the end of the test food ingestion period).
9.Subjects who have extremely irregular lifestyles.
10.Subjects who are currently participating in other studies, or participated in other studies within the past 3 months from the time of the informed consent.
11.Subjects who participate in other studies during this study.
12.Subjects who will not maintain their daily routines.
13.Subjects who have difficulty in taking the test food as instructed.
14.Subjects who are pregnant or breastfeed, or planning to become pregnant during this study
15.Subjects who are consideredas unsuitable participant for the study by the doctor and investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Sayuri |
| Middle name | |
| Last name | Matsuoka |
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
045-820-3532
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kitahara |
Organization
APO PLUS STATION CO., LTD.
Division name
CRO Department Clinical Operations Division
Zip code
103-0027
Address
2-14-1,Nihonbashi,Chuo-ku,Tokyo, Japan
TEL
03-6386-8809
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
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
Hitachi Omika Hospital
Address
2-22-30,Omika-cho,Hitachi-shi,Ibaraki-ken
Tel
029-487-9111
masaki.ohata@medical-art.co.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
医療法人社団盟生会 東新宿クリニック
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 31 | 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
| 2021 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 12 | 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 | 10 | Month | 15 | Day |
Last modified on
| 2022 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052247
