UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031502
Receipt number R000035961
Scientific Title A study for safety evaluation of excess consumption of the test drink containing citric acid
Date of disclosure of the study information 2019/02/27
Last modified on 2020/10/09 10:49:30

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Basic information

Public title

A study for safety evaluation of excess consumption of the test drink containing citric acid

Acronym

A study for safety evaluation of excess consumption of the test drink containing citric acid

Scientific Title

A study for safety evaluation of excess consumption of the test drink containing citric acid

Scientific Title:Acronym

A study for safety evaluation of excess consumption of the test drink containing citric acid

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Safety evaluation when healthy adults consume excess amount of the test food in 4 consecutive weeks.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Presence or absence of, type of, severity of and frequency of side effects and adverse events (include clinical test data).

Key secondary outcomes

Presence or absence of abnormal fluctuation of clinical test data.


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 1470mL of the test drink a day, four 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


Not applicable

Gender

Male and Female

Key inclusion criteria

(1)Males and females aged over 20 years old when consent acquisition.
(2)Subjects giving written informed consent.

Key exclusion criteria

(1)Subjects who are given continuous treatment by taking medicines.
(2)Subjects who constantly use oral medicines, food for specific health use, functional display foods and/or supplements having a possibility of affecting test results.
(3)Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
(4) Subjects who have previous and/or current medical history of serious disease in heart, liver, kidney, digestive organ.
(5) Subjects who excessive alcohol intake.
(6)Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
(7) Subjects who have previous medical history of drug and/or food allergy.
(8) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
(9) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
(10) Males who donated over 400mL blood and/or blood components within the last three month to the current study.
(11) Females who donated over 400mL blood and/or blood components within the last four month to the current study.
(12) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(13) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(14) Others who have been determined ineligible by principal investigator or sub-investigator.

Target sample size

16


Research contact person

Name of lead principal investigator

1st name Katsuhisa
Middle name
Last name Sakano

Organization

CPCC Company Limited

Division name

Clinical Research Planning Department

Zip code

101-0047

Address

4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

TEL

03-5297-3112

Email

info@cpcc.co.jp


Public contact

Name of contact person

1st name Kazuyoshi
Middle name
Last name Shibata

Organization

CPCC Company Limited

Division name

Planning & Sales Department

Zip code

101-0047

Address

4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

TEL

03-5297-3112

Homepage URL


Email

cpcc-contact@cpcc.co.jp


Sponsor or person

Institute

CPCC Company Limited

Institute

Department

Personal name



Funding Source

Organization

Kowa Company, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

Tel

03-5297-5548

Email

IRB@cpcc.co.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



Other administrative information

Date of disclosure of the study information

2019 Year 02 Month 27 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 02 Month 15 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 28 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 02 Month 27 Day

Last modified on

2020 Year 10 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035961


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name