UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051963 |
|---|---|
| Receipt number | R000059305 |
| Scientific Title | Effect of test food intake on liver function. -Randomized, double-blind, placebo-controlled parallel-group study- |
| Date of disclosure of the study information | 2023/08/21 |
| Last modified on | 2024/05/09 14:04:50 |
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Basic information
Public title
Effect of test food intake on liver function.
-Randomized, double-blind, placebo-controlled parallel-group study-
Acronym
Effect of test food intake on liver function.
Scientific Title
Effect of test food intake on liver function.
-Randomized, double-blind, placebo-controlled parallel-group study-
Scientific Title:Acronym
Effect of test food intake on liver function.
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of 8 weeks of consumption of the test food on liver function marker values.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ALT
Key secondary outcomes
Secondary outcomes
AST, gamma-GT, Fatigue VAS, OSA-MA, triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol, glucose, HbA1c(NGSP)
Safety outcomes
Incidence of side effects, Adverse Event Rate
Other outcomes
Physical measurement items, Physiological test items, Laboratory test items excluding efficacy endpoints
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
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food for 8 weeks
Interventions/Control_2
Intake of placebo food for 8 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 males and females between 20 and 65 years of age at the time of consent to participate in the study
2) Subjects with ALT >= 20 U/L and <= 50 U/L in screening test
3) Subjects who can visit on schedule days
4) Subjects who recognize the object and contents of the study and submit the written informed consent
Key exclusion criteria
1) Subjects with chronic diseases and taking medication
2) Subjects with a history of serious liver disease (viral hepatitis, drug-induced liver injury, cirrhosis) or suspected of currently having such disease
3) Subjects suffering from mental illness, sleep disorders, cardiac or renal disease, diabetes or other serious illnesses
4) Subjects with a history of severe illness in the past that would be considered problematic for study participation
5) Subjects who may show allergic symptoms to ingredients in the test food
6) Shift workers or late-night workers whose work schedule exceeds 0:00 AM
7) Subjects with extremely irregular daily habits and eating habits
8) Subjects with systolic blood pressure less than 90 mmHg
9) Subjects with an average daily drinking habit of 60 g/day or more of pure alcohol in the one-week alcohol consumption survey starting the day after the screening test
10) Subjects who have experienced moodiness or worsening of physical condition due to blood collection in the past
11) Subjects who regularly use medicines, quasi-drugs, herbal medicines, or health foods (including supplements) that may affect the study
12) Subjects who fail to comply with the requests to subjects during the study period
13) Subjects participating in another clinical trial at the time of screening test or within 2 months prior to study entry
14) Subjects who have donated component blood or had at least 200 mL of whole blood drawn in the month prior to the screening test or plan to do so during the study period
15) Subjects who have an average of 10 or more days per month of business travel or trips
16) Subjects who wish to become pregnant, are pregnant (including possible pregnancy), or are lactating
17) Other subjects deemed inappropriate by the investigator based on medical examination data, etc
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kosei |
| Middle name | |
| Last name | Tsukamoto |
Organization
Rohto Pharmaceutical Co.
Division name
Internal medicine and Functional food Development Division Function Development Group
Zip code
544-8666
Address
1-8-1 Tatsumi Nishi, Ikuno-ku, Osaka City, Osaka, Japan
TEL
06-6758-9848
kouseit@rohto.co.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Zembutsu |
Organization
New drug research center, Inc.
Division name
Clinical Research Group of Food Clinical Research Dept.
Zip code
061-1405
Address
452-1 Toiso, Eniwa, Hokkaido, Japan
TEL
0123-34-0412
Homepage URL
k-zenbutsu@ndrcenter.co.jp
Sponsor or person
Institute
Rohto Pharmaceutical Co.
Institute
Department
Personal name
Funding Source
Organization
Rohto Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
MG PHARMA Inc.
IRB Contact (For public release)
Organization
Medical Corporation Jikokai Fukuzumi Internal Medicine Clinic Clinical Trial Review Committee
Address
1-2-5 Itoyokado Fukuzumiten-5F Fukuzumi-2jo, Toyohira-ku, Sapporo, Hokkaido, Japan
Tel
011-836-3531
shibata@jkkai.or.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
福原医院（北海道）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 21 | 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
| 2023 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 21 | Day |
Last modified on
| 2024 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059305
