UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024433
Receipt number R000028121
Scientific Title A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Plant Extract. (Ex.no.H28-0827)
Date of disclosure of the study information 2016/10/18
Last modified on 2020/03/31 23:35:44

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Basic information

Public title

A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Plant Extract. (Ex.no.H28-0827)

Acronym

A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Plant Extract.

Scientific Title

A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Plant Extract. (Ex.no.H28-0827)

Scientific Title:Acronym

A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Plant Extract.

Region

Japan


Condition

Condition

Healthy Adult

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of excessive consumption of beverage containing plant extract for 4 weeks in healthy adult.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Medical examination by blood biochemistry, hematology, urinalysis, physical examination at 2-week and 4-week consumption.

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

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

test food containing plant extract
4 weeks excessive consumption.

Interventions/Control_2

control food containing plant extract (commercial product)
4 weeks excessive consumption.

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

(1) (Healthy) subjects aged 20 to 64 years old.

(2) Subjects giving written informed consent.

Key exclusion criteria

(1) Subjects with serious medical history of hepatic, renal, cardiovascular, respiratory and intestinal disease.

(2) Subjects taking any kind of medicine or supplement which affect the result of the trial for habitual use.

(3) Subjects with serious food allergy .

(4) Subjects who are judged as unsuitable for the study by the investigator for the other reasons.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Moriyama

Organization

Kanazawabunko Hospital

Division name

Deputy Director

Zip code

236-0042

Address

2-6-22,Kamariyahigashi,Kanazawa-ku, Yokohama sity,Kanagawa,Japan

TEL

045-785-3311

Email

nagashima@kanabun-hp.jp


Public contact

Name of contact person

1st name Hitomi
Middle name
Last name Nasu

Organization

QOL RD Co.,Ltd.

Division name

CRO Department Food Division

Zip code

103-0023

Address

2-14-1,Nihonbashi,Chuo-Ku,Tkyo,

TEL

03-6386-8809

Homepage URL


Email

h-nasu@qol-rd.co.jp


Sponsor or person

Institute

QOL RD Co.,Ltd.

Institute

Department

Personal name



Funding Source

Organization

Kao 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

Kanazawabunko Hospital IRB

Address

2-6-22,Kamariyahigashi,Kanazawa-ku, Yokohama sity,Kanagawa,Japan

Tel

045-785-3311

Email

nagashima@kanabun-hp.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

金沢文庫病院(神奈川県)、白岡中央総合病院(埼玉県)、埼玉回生病院(埼玉県)


Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 18 Day


Related information

URL releasing protocol

Unpublished due to the protocol including the intellectual property rights

Publication of results

Unpublished


Result

URL related to results and publications

works in progress

Number of participants that the trial has enrolled

32

Results

No significant difference in the primary outcome

Results date posted

2020 Year 03 Month 31 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Healthy subjects

Participant flow

32 participants completed and 32 subjects were incorporated into the analyses

Adverse events

No adverse effect related to the test diets reported

Outcome measures

Safety

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 09 Month 21 Day

Date of IRB

2016 Year 09 Month 21 Day

Anticipated trial start date

2016 Year 10 Month 19 Day

Last follow-up date

2017 Year 02 Month 23 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 10 Month 17 Day

Last modified on

2020 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028121


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name