UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037244 |
|---|---|
| Receipt number | R000042473 |
| Scientific Title | Evaluation of long term intake of test supplement on safety -open labeled study- |
| Date of disclosure of the study information | 2019/07/15 |
| Last modified on | 2020/06/12 09:04:55 |
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Basic information
Public title
Evaluation of long term intake of test supplement on safety -open labeled study-
Acronym
Safety of long term intake of test supplement
Scientific Title
Evaluation of long term intake of test supplement on safety -open labeled study-
Scientific Title:Acronym
Safety of long term intake of test supplement
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to assess the safety of 12 consecutive weeks of intake of test supplement
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hematologic test
Blood biochemistry test
Urine analysis
Blood pressure/pulsation
Weight/body mass index
Doctor's question
Adverse event
Key secondary outcomes
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 of test supplement for 12 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Male and female whose age is between 20 and 64 years old
Key exclusion criteria
(1) Subjects who have diabetes, liver disease, kidney disease, heart disease, diseases that affect the secretion of adrenocortical hormones, other metabolic diseases, or subjects who have a history of such diseases
(2) Subjects who have diseases requiring continuous medication, or serious medical history who needed medication
(3) Subjects who routinely use some medicine (including over-the-counter drug)
(4) Subjects who are judged as unsuitable for the study based on the results of clinical laboratory test or cardiopulmonary function
(5) Subjects with allergies to the test food in this study
(6) Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period
(7) Subjects who have participated in other clinical study within the past month prior
(8) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(9) Subjects who are judged as unsuitable for the study based on the results of clinical laboratory test or physical examination
(10) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Yui |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
2440806
Address
12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
0458203755
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | Yoshimi |
| Middle name | |
| Last name | Bansho |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
150-0021
Address
1-20-2, Ebisu-nishi, Shibuya-ku, Tokyo, Japan
TEL
03-5459-5329
Homepage URL
y.bansho@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aisei Hospital Ueno Clinic Research Ethics Committee
Address
2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel
03-6455-0880
t.saito@ttc-smo.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
メディカルステーションクリニック
公益財団法人愛世会 愛誠病院 上野クリニック
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 15 | 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
| 2019 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 03 | Day |
Last modified on
| 2020 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042473
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
