UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028377 |
|---|---|
| Receipt number | R000032487 |
| Scientific Title | A study for safety evaluation of excess consumption of the test food. |
| Date of disclosure of the study information | 2018/07/26 |
| Last modified on | 2020/10/06 08:54:28 |
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Basic information
Public title
A study for safety evaluation of excess consumption of the test food.
Acronym
A study for safety evaluation of excess consumption of the test food.
Scientific Title
A study for safety evaluation of excess consumption of the test food.
Scientific Title:Acronym
A study for safety evaluation of excess consumption of the test food.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety evaluation when healthy adults consume excess amount of the test food in 4 consecutive weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of, type of, severity of and frequency of side effects and adverse events (include clinical test data).
Key secondary outcomes
The inspection items at 2 and 4 weeks after beginning of ingestion of the test food, and at 2 weeks after end of ingestion of the test food as follows.
Medical interview, body length, body weight, body fat percentage, BMI, systolic blood pressure, diastolic blood pressure, heart rate, blood biochemical test (TP, ALB, AST, ALT, LDH, T-BIL, ALP, ganma-GTP, CPK, BUN, CRE, UA, Na, Cl, K, Ca, T-Cho, LDL-Cho, HDL-Cho, TG, GLC, HbA1c) , hematological test (WBC, RBC, Hb, Ht, and PLT), and urine analysis (protein, sugar, urobilinogen, bilirubin)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake nine capsules,which contain the test food, at once, three times a day, four consecutive weeks.
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Male and female aged over 20 years old when consent acquisition.
(2)Subjects giving written informed consent.
Key exclusion criteria
(1)Subjects who constantly use oral medicines, food for specific health use, functional display foods and/or supplements having a possibility of affecting test results.
(2) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
(3) Subjects who have previous and/or current medical history of serious disease in heart, liver, kidney, digestive organ.
(4) Subjects who excessive alcohol intake.
(5) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
(6) Subjects who have previous medical history of drug and/or food allergy.
(7) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
(8) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
(9) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study.
(10) Females who donated over 400mL blood and/or blood components within the last four month to the current study.
(11) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(12) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(13)Subjects who have weak digestive organ. Especially subjects who feel discomfort for example stomach astigmatism after intake of drinks containing tannin like strong green tea, black tea and coffee.
(14) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Katsuhisa |
| Middle name | |
| Last name | Sakano |
Organization
CPCC Company Limited
Division name
Clinical Research Planning Department
Zip code
101-0047
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Planning & Sales Department
Zip code
101-0047
Address
4F Chusin Building, 3-3-5 Uchikanda 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
NAGAOKA 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
| 2018 | Year | 07 | Month | 26 | 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
| 2017 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 26 | Day |
Last modified on
| 2020 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032487
