UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032454
Receipt number 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 10:24:58

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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 or person

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name



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

Value
https://center6.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