UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044415 |
|---|---|
| Receipt number | R000050745 |
| Scientific Title | Evaluation of the improving effects on liver function, status of fatigue, mood, and sleep after ingestion of the supplement |
| Date of disclosure of the study information | 2022/10/23 |
| Last modified on | 2023/08/09 13:40:29 |
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Basic information
Public title
Evaluation of the improving effects on liver function, status of fatigue, mood, and sleep after ingestion of the supplement
Acronym
Evaluation of the improving effects on liver function, status of fatigue, mood, and sleep after ingestion of the supplement
Scientific Title
Evaluation of the improving effects on liver function, status of fatigue, mood, and sleep after ingestion of the supplement
Scientific Title:Acronym
Evaluation of the improving effects on liver function, status of fatigue, mood, and sleep after ingestion of the supplement
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the improving effects of liver function and status of fatigue, mood, and sleep on subjects with relatively high liver function after ingestion of the supplement
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Liver function indexes (ALT and AST) before the study and 4, 8, and 12 weeks after using the test food
Key secondary outcomes
gamma-GTP, ALP, Fatigue VAS, Japanese short version of POMS2, OSA sleep inventory MA version at before the study and 4, 8, 12 weeks after using the test food
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake the research food for 12 consecutive weeks
Interventions/Control_2
Intake the placebo food for 12 consecutive 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females from 20 to 64 years old
(2) The ALT level in the range from 31 to 50 U/L, and the AST level is relatively high will be considered first
Key exclusion criteria
(1) Subjects who ALT levels >= 51 U / L or AST levels >= 51 U / L or gamma-GTP levels >= 101 U / L on the preliminary examination
(2) Subjects who are positive for HCV antibody or HbsAg on the preliminary examination
(3) Subjects who cannot accomplish the intact inspection procedure as prescribed
(4) Subjects who are judged as unsuitable for the study based on the results of the lifestyle questionnaire
(5) Subjects who constantly use health food richly containing involvement ingredient
(6) Subjects who constantly use supplements or drugs affecting the liver function
(7) Subjects who constantly use supplements or drugs affecting the status of fatigue, mood, and sleep
(8) Subjects who have serious illnesses such as diabetes, liver disease, kidney disease, heart disease, and cancer or history of those illnesses
(9) Subjects having possibilities for emerging allergy related to the study
(10) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(11) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(12) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(13) Subjects who intend to become pregnant or lactating during the test period
(14) Subjects who habitually do intense exercise such as marathon.
(15) Subjects who take constant or frequent night shifts
(16) Subjects judged as unsuitable for the study by the principle investigator for other reasons
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Jiro |
| Middle name | |
| Last name | Saito |
Organization
Medical Station Clinic
Division name
none
Zip code
152-0004
Address
3-12-8, Takaban, Meguroku, Tokyo
TEL
03-6452-2712
info@med-station.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Yasui |
Organization
EP Mediate Co., Ltd.
Division name
Development Business Headquarters, TTC Center, Trial Planning Department
Zip code
162-0822
Address
Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo
TEL
03-5657-4983
Homepage URL
yasui475@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Greenyn Biotechnology Co., 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
saito876@eps.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 23 | 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 | 05 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 23 | 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 | 03 | Day |
Last modified on
| 2023 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050745
