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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028275
Receipt No. 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

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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
Institute TTC CO., LTD.
Institute
Department

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
URL(English) https://upload.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


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