UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028275
Receipt number R000032369
Scientific Title Safety evaluation of long-term intake of drink containing plant-derived anthocyanin for healthy adults or subjects with high normal liver function
Date of disclosure of the study information 2017/07/18
Last modified on 2018/09/05 13:43:30

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Basic information

Public title

Safety evaluation of long-term intake of drink containing plant-derived anthocyanin for healthy adults or subjects with high normal liver function

Acronym

Safety evaluation of long-term intake of drink containing plant-derived anthocyanin

Scientific Title

Safety evaluation of long-term intake of drink containing plant-derived anthocyanin for healthy adults or subjects with high normal liver function

Scientific Title:Acronym

Safety evaluation of long-term intake of drink containing plant-derived anthocyanin

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of long-term intake of drink containing plant-derived anthocyanin, quantity of recommended daily intake (160 g), for 12 weeks

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Hematologic test, Blood biochemistry test, Urine test, Blood pressure/pulsation, Weight/body mass index, Medical Interview, before and 4, 8, 12 weeks after intake and 4 weeks after the end of intake period and Adverse events thorough the study

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

Intake of drink containing plant-derived anthocyanin, quantity of recommended daily intake, for 12 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

64 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Males and females from 20 to 64 years of age
(2) The liver function test value at the time of preliminary examination corresponds to the normal range or health guidance judgment value, and subjects who judged by a healthy person and a doctor from other inspection results
A. Subjects who satisfy all conditions of ALT 30 U/L or less, AST 30 U/L or less and gamma-GT 50 U/L or less (10 subjects)
B. Subjects who satisfy under at least one of the conditions of ALT 31 U/L or more, AST 31 U/L or more, or gamma-GT 51 U/L or more (10 subjects)

Key exclusion criteria

(1) Subjects who constantly use health food richly containing involvement ingredient
(2) Subjects who constantly use supplements or drugs affecting the liver function
(3) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(4) Subjects having possibilities for emerging allergy related to the study
(5) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(6) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(7) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(8) Subjects who intend to become pregnant or lactating
(9) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(10) Subjects judged as unsuitable for the study by the investigator for other reasons

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuyoshi Kano

Organization

YAKULT HONSHA CO., LTD

Division name

Research Management Center Yakult Central Institute

Zip code


Address

5-11, Izumi, Kunitachi-shi, Tokyo, Japan

TEL

042-577-8960

Email

mitsuyoshi-kano@yakult.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinsuke Tsuji

Organization

TTC CO., LTD.

Division name

Clinical Research Planning Department

Zip code


Address

Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL


Email

s.tsuji@ttc-tokyo.co.jp


Sponsor or person

Institute

TTC CO., LTD.

Institute

Department

Personal name



Funding Source

Organization

YAKULT HONSHA CO., 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


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



Other administrative information

Date of disclosure of the study information

2017 Year 07 Month 18 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

Items in which significant changes were observed in the average values of clinical laboratory test values and measured values compared with those before ingestion were found, but both were minor fluctuations, and if they were not clinically problematic fluctuations, the doctor It was judged by the responsible person.
Twenty-four adverse events occurred in eleven out of twenty-one patients, but there were no serious adverse events and symptoms were all mild, and all relevance to the research food was "None" It was done.
Based on the above results, it was shown that there is no problem in safety on long-term ingestion of plant-derived anthocyanin-containing beverages under this research condition.

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

2017 Year 07 Month 13 Day

Date of IRB


Anticipated trial start date

2017 Year 07 Month 19 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

2017 Year 07 Month 18 Day

Last modified on

2018 Year 09 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032369


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name