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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032454
Receipt No. R000037000
Scientific Title The verification study for safety evaluation of long-term administration of the test beverage in humans: an open-label trial
Date of disclosure of the study information 2018/05/02
Last modified on 2018/11/01

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Basic information
Public title The verification study for safety evaluation of long-term administration of the test beverage in humans: an open-label trial
Acronym The verification study for safety evaluation of long-term administration of the test beverage in humans
Scientific Title The verification study for safety evaluation of long-term administration of the test beverage in humans: an open-label trial
Scientific Title:Acronym The verification study for safety evaluation of long-term administration of the test beverage in humans
Region
Japan

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

Objectives
Narrative objectives1 To identify the safety of long-term administration of calcium-blended lemon beverage
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Physical examination
2. Urinalysis
3. Blood test
4. Subjective symptoms (the Likert scale)

* Assess at screening and examination before consuming, at 4, 8, and 12 weeks after ingestion, and follow-up period for 4 weeks
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 Duration: 12 weeks
Follow-up duration: 4 weeks
Test material: Calcium-blended lemon beverage
Dosage: Drink one bottle (350 mL) of the test beverage per day at any time of the day

* Daily dose must be taken within the 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Healthy Japanese adult people

2. Subjects who are judged as eligible to participate in the study by the physician
Key exclusion criteria 1. A medical history of malignant tumor, heart failure or myocardial infarction

2. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

3. Subjects who have a medical history of calculus

4. Subjects who are under the treatment of osteoporosis

5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily

6. Currently taking medicines (include herbal medicines) and supplements

7. Subjects who take fortified food/beverage with calcium in daily

8. Subjects who are allergic to medicines and/or the test beverage related products

9. Subjects who was on medication for hay fever for the last 3 years

10. Subjects who are pregnant, lactation, and planning to become pregnant

11. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial

12. 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
Middle name
Last name Kazuo YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
Zip code
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
Middle name
Last name Naoko SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code
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 POKKA SAPPORO FOOD & BEVERAGE LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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)

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 02 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
2018 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 02 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
2018 Year 05 Month 02 Day
Last modified on
2018 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037000

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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