UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044208
Receipt number R000050477
Scientific Title Safety evaluation of long term intake of test supplement
Date of disclosure of the study information 2021/05/16
Last modified on 2023/11/14 09:16:46

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Safety evaluation of long term intake of test supplement

Acronym

Safety evaluation of long term intake of test supplement

Scientific Title

Safety evaluation of long term intake of test supplement

Scientific Title:Acronym

Safety evaluation of long term intake of test supplement

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To evaluate the safety of ingestion of test supplement containing plant extract for 12 consecutive weeks, using placebo as a control.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Hematologic test
Blood biochemistry test
Urine analysis
Blood pressure/pulsation
Body weight/body mass index
Doctor's question
Adverse event

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of test supplement for 12 consecutive weeks

Interventions/Control_2

Intake of placebo for 12 consecutive weeks

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

Male and female whose age is between 20 and 64 years old.

Key exclusion criteria

1. Subjects who are judged as unsuitable for the study based on the results of clinical laboratory test or cardiopulmonary function.
2. Subjects who have allergy related to this study.
3. Subjects who have diseases requiring continuous medication, or serious medical history who needed medication.
4. Subjects whose clinical laboratory tests, blood pressure, and physical measurements before intake of trial supplements are significantly out of the standard values.
5. Subjects who have participated in other clinical studies.
6. Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period.
7. Subjects who are judged as unsuitable for the study based on the answers of background survey.
8. Subjects who are judged as unsuitable for the study by the investigator for other reasons.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Kei
Middle name
Last name Yui

Organization

FANCL Corporation

Division name

12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa

Zip code

244-0806

Address

12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa

TEL

045-820-3755

Email

ke-yui@fancl.co.jp


Public contact

Name of contact person

1st name Saki
Middle name
Last name Miyayama

Organization

EP Mediate Co., Ltd.

Division name

Development Business Headquarters, TTC Center, Trial Planning Department

Zip code

162-0822

Address

Tsuruya Bldg., 2-23 Shimomiyabi-cho, Shinjuku-ku, Tokyo

TEL

03-5657-4983

Homepage URL


Email

miyayama392@eps.co.jp


Sponsor or person

Institute

FANCL Corporation

Institute

Department

Personal name



Funding Source

Organization

FANCL Corporation

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

Medical Station Clinic Research Ethics Committee

Address

3-12-8, Takaban, Meguroku, Tokyo

Tel

080-2290-2544

Email

makabe295@eps.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

医療法人社団幸和会 幸和クリニック


Other administrative information

Date of disclosure of the study information

2021 Year 05 Month 16 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

2021 Year 04 Month 22 Day

Date of IRB

2021 Year 04 Month 22 Day

Anticipated trial start date

2021 Year 05 Month 17 Day

Last follow-up date

2021 Year 09 Month 21 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 05 Month 14 Day

Last modified on

2023 Year 11 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050477


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name