UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042678 |
|---|---|
| Receipt number | R000048700 |
| Scientific Title | Confirmation trial for safety and improvement effects by test-food ingestion on impaired liver function. |
| Date of disclosure of the study information | 2022/01/25 |
| Last modified on | 2022/04/15 15:39:09 |
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Basic information
Public title
Confirmation trial for safety and improvement effects by test-food ingestion on impaired liver function.
Acronym
Confirmation trial for safety and improvement effects by test-food ingestion on impaired liver function.
Scientific Title
Confirmation trial for safety and improvement effects by test-food ingestion on impaired liver function.
Scientific Title:Acronym
Confirmation trial for safety and improvement effects by test-food ingestion on impaired liver function.
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to evaluate whether test-food intakes can reveal some kind of improvement effect against an impaired liver function, as well as its clinical safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate of adverse events and side effects
Key secondary outcomes
1. ALT value
2. Physical measurement
3. Physiological test
4. Hematological test
5. Blood biochemical test, excluding ALT
6. General urine test
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test material: Soft capsule containing 20 mg of paprika extract per capsule
Dose: five capsules per day
Administration: Take the capsule with water or warm water after breakfast
Interventions/Control_2
Duration: 12 weeks
Test material: Placebo soft capsule (not include paprika extract)
Dose: five capsules per day
Administration: Take the capsule with water or warm water after breakfast
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy male/female subjects ranging in age from 20 to 59, at the moment of giving informed consent to participate in this trial.
2. Healthy subjects ranging in BMI from 18.5 to no more than 30.
3. Subjects ranging in ALT from 31 to no more than 51, at the moment of giving informed consent to participate in this trial.
4. Subjects who can give informed consent to take part in this trial after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects with some kind of medical treatment continuously.
2. Subjects who have used the following foods that might affect their test result; health-specific, functional, health foods, etc., with any difficulty in refraining from having those.
3. Pregnant or possibly pregnant women, or lactating ones.
4. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
5. Subjects with excessive alcohol intake.
6. Subjects with extremely irregular life rhythms, and subjects with midnight work or irregular shift work.
7. Subjects with previous medical history of drug and/or food allergy.
8. Subjects falling into the habit of smoking.
9. Subjects who are now under the other clinical tests with some kind of medicine/food, or going to take part in those tests within four weeks after the current trial.
10. Subjects who donated over 200 mL of their whole blood and/or blood components within a month to the current trial.
11. Male subjects who donated over 400 mL of their whole blood within the last three months to the current trial.
12. Female subjects who donated over 400 mL of their whole blood within the last four months to the current trial.
13. Male subjects who will be collected over 1200 mL in total of their blood within the last twelve months, after adding the planned sampling blood amounts in this trial.
14. Female subjects who will be collected over 800 mL in total of their blood within the last twelve months, after adding the planned sampling blood amounts in this trial.
15. Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinions.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | |
| Last name | FUJIWARA |
Organization
CPCC Company Limited
Division name
Division of Clinical Research
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | FUJIMOTO |
Organization
CPCC Company Limited
Division name
Planning & Sales Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Riken Vitamin 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.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 | 01 | Month | 25 | 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
48
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
| 2020 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 07 | Day |
Last modified on
| 2022 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048700
