UMIN-CTR Clinical Trial

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
Email	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
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048700