![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
![]() |
Name | UMIN ID |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000048542 |
Receipt No. | R000055302 |
Scientific Title | A verification study of safety evaluation of excessive the test food consumption in humans: an open-label trial |
Date of disclosure of the study information | 2022/08/01 |
Last modified on | 2022/08/01 |
Basic information | ||
Public title | A verification study of safety evaluation of excessive the test food consumption in humans | |
Acronym | A verification study of safety evaluation of excessive the test food consumption in humans | |
Scientific Title | A verification study of safety evaluation of excessive the test food consumption in humans: an open-label trial | |
Scientific Title:Acronym | A verification study of safety evaluation of excessive the test food consumption in humans | |
Region |
|
Condition | |||
Condition | Healthy Japanese subjects | ||
Classification by specialty |
|
||
Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To verify the safety of overdose the test food for four weeks in healthy Japanese subjects |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | 1. Incidence of adverse events |
Key secondary outcomes | 1. The proportion of subjects whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at screening (before consumption; Scr) |
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 |
|
|
Interventions/Control_1 | Duration: Four weeks
Test food: "New HG Premier Powder" Administration: Take five packets with water pre- or post-breakfast per day *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day. |
|
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | 1. Japanese
2. Men or women 3. Subjects aged 20 or more 4. Healthy subjects |
|||
Key exclusion criteria | 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products (particularly milk or soy) 7. Subjects who are pregnant, lactation, or planning to become pregnant during this trial 8. Subjects who suffer from COVID-19 9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who are judged as ineligible to participate in this study by the physician |
|||
Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Medical Corporation Seishinkai, Takara Clinic | ||||||
Division name | Director | ||||||
Zip code | 141-0022 | ||||||
Address | 9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan | ||||||
TEL | 03-5793-3623 | ||||||
t-takara@takara-clinic.com |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | ORTHOMEDICO Inc. | ||||||
Division name | R&D Department | ||||||
Zip code | 112-0002 | ||||||
Address | 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan. | ||||||
TEL | 03-3818-0610 | ||||||
Homepage URL | |||||||
nao@orthomedico.jp |
Sponsor | |
Institute | ORTHOMEDICO Inc. |
Institute | |
Department |
Funding Source | |
Organization | UN INTERNATIONAL CO.,LTD. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | the ethical committee of the Takara Clinic, Medical Corporation Seishinkai |
Address | 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan. |
Tel | 03-5793-3623 |
IRB@takara-clinic.com |
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 | 医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan) 南町医院 (東京都) Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan) |
Other administrative information | |||||||
Date of disclosure of the study information |
|
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 | Open public recruiting | ||||||
Date of protocol fixation |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055302 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |