UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045917 |
|---|---|
| Receipt number | R000052398 |
| Scientific Title | Verification of efficacy and long-term intake safety of test food intake for liver function in healthy adults |
| Date of disclosure of the study information | 2021/10/29 |
| Last modified on | 2022/12/21 13:51:00 |
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Basic information
Public title
Verification of efficacy and long-term intake safety of test food intake for liver function in healthy adults
Acronym
Verification of efficacy and long-term intake safety of test food intake for liver function in healthy adults
Scientific Title
Verification of efficacy and long-term intake safety of test food intake for liver function in healthy adults
Scientific Title:Acronym
Verification of efficacy and long-term intake safety of test food intake for liver function in healthy adults
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to verify the effectiveness and long-term intake safety of test food intake for liver function in healthy adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Liver function markers(ALT,AST,Gamma-GTP)
Key secondary outcomes
(Safety evaluation)
Vital signs, physical measurement, blood biochemistry, hematology, urinalysis, adverse events
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
16-weeks intake of the test food
Interventions/Control_2
16-weeks intake of the placebo food
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Japanese healthy male and female subjects whose ages are 30 <= years old <65 at the time of obtaining written consent.
2.Subject who is not currently receiving treatment or medication.
3.Subject whose liver function marker values correspond to one of the following two.
a.Liver function marker (ALT) is normal, ALT is 20 or more and 30 or less.
b.Liver function marker (ALT) is slightly higher, ALT is 31 or more and 50 or less.
4.Subject who has received sufficient explanation of the purpose and content of the research, have the ability to consent, voluntarily volunteered to participate in the examination after understanding it well, and agreed to participate in the examination in writing.
5.Subject who is not expected to meet the exclusion criteria from the results of the primary SCR background questionnaire.
Key exclusion criteria
1.Subject who has been diagnosed with serious liver disease (viral hepatitis, drug-induced liver injury, liver cirrhosis, etc.) by a doctor, or those who have a medical history or are suspected (hepatitis virus test positive, etc.)
2.Subject who is currently undergoing medication or outpatient treatment due to some serious illness.
3.Subject who is under exercise therapy or dietetic therapy.
4.Subject who may develop allergies due to test foods.
5.Subject with current or history of drug or alcohol dependence.
6.Alcohol polydipsia.
7.Subject who is out of the hospital due to mental disorders (depression, etc.) or sleep disorders(Insomnia, sleep apnea syndrome, etc.), or who has a history of mental illness in the past.
8.Subject with irregular life rhythms due to night shifts or shift work.
9.Subject who has extremely irregular lifestyle habits such as eating and sleeping.
10.Subject who has an extremely unbalanced diet.
11.Subject with serious current or history of brain disease, malignant tumor, immune disease, diabetes, renal disease, heart disease, thyroid disease, adrenal disease, and other metabolic diseases.
12.Subject who uses or cannot refrain from using health foods, supplements, medicines, quasi-drugs, Chinese medicine, etc. that contain ingredients that affect liver function (eg, ornithine, sulforaphane, turmeric, etc.)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Yamatsu |
Organization
Pharma Foods International Co., Ltd.
Division name
Research and Development
Zip code
615-8245
Address
1-49, Goryo-ohara, nishikyo-ku, Kyoto city, Kyoto, Japan
TEL
075-748-9829
a-yamatsu@pharmafoods.co.jp
Public contact
Name of contact person
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
toya@huma-rd.co.jp
Sponsor or person
Institute
Pharma Foods International Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Corporation Life Sciences Limited
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
Ethics Committees of Yoga Allergy Clinic
Address
4-32-16 Yoga,Setagaya-ku,Tokyo 158-0097 Japan
Tel
03-5491-4478
jim@medipharma.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
FH20-002
Org. issuing International ID_1
HUMA R&D CORP
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 29 | 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 | 10 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 24 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 11 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 02 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 19 | Day |
Other
Other related information
(Exclusion criteria continued)
13.Subject who has participated in other clinical trials (research) within 2 months from the date of consent acquisition, or those who plan to participate in other clinical trials (research) during the trial period.
14.Subject who cannot take the test food as instructed during the test period.
15.Subject who has collected more than 200 mL of blood or donated more than 400 mL of blood within 1 month or 3 months from the date of consent acquisition.
16.Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
17.Subject who has difficulty observing records on various survey forms.
18.Subject judged to be inappropriate as subjects based on clinical laboratory test values and measured values at the time of SCR.
19.Others who are judged by the investigator to be inappropriate as subjects.
Management information
Registered date
| 2021 | Year | 10 | Month | 29 | Day |
Last modified on
| 2022 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052398
