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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041294
Receipt No. R000047157
Scientific Title A verification study of safety evaluation of excessive the test food consumption in humans: A randomized double-blind placebo-controlled trial
Date of disclosure of the study information 2020/08/03
Last modified on 2020/10/22

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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: A randomized double-blind placebo-controlled trial
Scientific Title:Acronym A verification study of safety evaluation of excessive the test food consumption in humans
Region
Japan

Condition
Condition Healthy Japanese subjects
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the safety of consuming five times the daily intake for four weeks in healthy Japanese subjects.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Incidence of side effects
2. Incidence of adverse events
Key secondary outcomes 1. Physical examination
2. Urinalysis
3. Blood test
4. Original questionnaires
5. The measured values of the total score of self-administered dementia checklist (SDC), and the score of cognitive function and life function at two and four weeks after the start of test-food consumption
6. The change of the total score of SDC, and the score of cognitive function and life function at two and four weeks after the start of test-food consumption
7. The measured value of BDNF at four weeks after the start of test-food consumption
8. The change of BDNF at four weeks after the start of test-food consumption
9. The measured values of all of the total score of SDC at two and four weeks after the start of test-food consumption

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Duration: Four weeks
Test food: Capsule containing lipid-soluble polyphenol
Administration: Take five capsules per day after breakfast with water.


*If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2 Duration: Four weeks
Test food: Placebo
Administration: Take five capsules per day after breakfast with water.

*If you forget to take the test food, take it as soon as you remember within the day.
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. Healthy Japanese adult subjects

2. Subjects who are judged as eligible to participate in the study by the physician
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. Currently undergoing treatment for any of the following chronic disease: 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", "Foods with Functional Claims", or other functional food/beverage in daily

5. Subjects currently regularly taking medications (including herbal medicines) and supplements

6. Subjects who are allergic to medicines and/or the test food related products

7. Subjects who are pregnant, breast-feeding, and planning to become pregnant

8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial

9. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kazuo
Middle name
Last name YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
Zip code 112-0002
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person
1st name Naoko
Middle name
Last name SUZUKI
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
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization Satsuma Shuzo 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
Email 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
2020 Year 08 Month 03 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 22
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 No longer recruiting
Date of protocol fixation
2020 Year 07 Month 27 Day
Date of IRB
2020 Year 07 Month 27 Day
Anticipated trial start date
2020 Year 08 Month 04 Day
Last follow-up date
2020 Year 12 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 08 Month 03 Day
Last modified on
2020 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047157

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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