UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030131
Receipt number R000034404
Scientific Title Examination of single ingestion of drink containing plant extract. A-17004
Date of disclosure of the study information 2017/11/27
Last modified on 2020/01/31 11:24:48

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Basic information

Public title

Examination of single ingestion of drink containing plant extract. A-17004

Acronym

Examination of single ingestion of drink containing plant extract. A-17004

Scientific Title

Examination of single ingestion of drink containing plant extract. A-17004

Scientific Title:Acronym

Examination of single ingestion of drink containing plant extract. A-17004

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Cardiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of plant extract on vascular function.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Skin temperature.

Key secondary outcomes

Peripheral blood flow and subjective evaluation.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Drink containing plant extract (single ingestion)->washout period->placebo drink not containing plant extract (single ingestion)

Interventions/Control_2

Placebo drink not containing plant extract (single ingestion) ->washout period->Drink containing plant extract (single ingestion)

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

35 years-old >=

Gender

Female

Key inclusion criteria

1.Healthy adults
2.Person whose estradiol cycle is stable between 28 and 32 days.
3.Person who is sensitive to cold.
4.Person whose body math indexes are from 18.5 or more to 25 less than 25.0
5.Person whose diastolic blood pressures are less than 90mmHg and systolic ones less than 140mmHg.
6.Person who agrees not to ingest specified foods and supplements during the test period.

Key exclusion criteria

1.Person who has severe allergic disease as rhinitis, atopicdermatitis.
2.Person who is pregnant, lactating or planned to become pregnant during the test period.
3.Patient with vascular function disorder.
4.Person who has problems with electrocardiogram test such as arrhythmia.
5.Person who takes medicine.
6.Person who regularly goes to hospital or went to the medical institution within a month.
7.Current smoker.
8.Person who plans to participate in the other clinical studies.
9.Person who is judged as unsuitable for the study by the investigator for other reasons.

Target sample size

24


Research contact person

Name of lead principal investigator

1st name Akane
Middle name
Last name Suma

Organization

Kao Corporation

Division name

R&D-Skin Care Products Research

Zip code

131-8501

Address

2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan

TEL

+81-3-5630-9581

Email

suma.akane@kao.com


Public contact

Name of contact person

1st name Shimizu
Middle name
Last name Ryoma

Organization

TES Holdings Co., Ltd

Division name

Administrative Department of Clinical Trials

Zip code

110-0015

Address

Kairaku Building 6F, Higashi-ueno, Taito-ku, Tokyo 113-0033, JAPAN

TEL

+81-3-6801-8480

Homepage URL


Email

r.shimizu@tes-h.co.jp


Sponsor or person

Institute

TES Holdings 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

Human Research Ethics Committee, Kao Corporation

Address

2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan

Tel

+81-3-5630-9220

Email

uesaka.toshio@kao.com


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

株式会社TESホールディングス(東京都)


Other administrative information

Date of disclosure of the study information

2017 Year 11 Month 27 Day


Related information

URL releasing protocol

Japanese Journal of Biometeorology, 56(2):89-99.2019

Publication of results

Published


Result

URL related to results and publications

Japanese Journal of Biometeorology, 56(2):89-99.2019

Number of participants that the trial has enrolled

24

Results

A cold stress (water temperature of 15 degC , 1 min) test was performed on both hands of each subject 50 minutes after ingesting 270mg of CGA and placebo. SkT and SkBF were then measured simultaneously before and after the cold stress test. Significant improvement of the recovery of SkT and SkBF after the cold stress test were observed in CGA compared with placebo. These findings suggested that the ingestion of CGA improves SkT and SkBF after cold stress.

Results date posted

2019 Year 07 Month 30 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Japanese Journal of Biometeorology, 56(2):89-99.2019

Participant flow

Japanese Journal of Biometeorology, 56(2):89-99.2019

Adverse events

Japanese Journal of Biometeorology, 56(2):89-99.2019

Outcome measures

Japanese Journal of Biometeorology, 56(2):89-99.2019

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 10 Month 30 Day

Date of IRB

2017 Year 10 Month 30 Day

Anticipated trial start date

2017 Year 11 Month 27 Day

Last follow-up date

2017 Year 12 Month 20 Day

Date of closure to data entry


Date trial data considered complete

2018 Year 11 Month 28 Day

Date analysis concluded

2019 Year 05 Month 17 Day


Other

Other related information



Management information

Registered date

2017 Year 11 Month 27 Day

Last modified on

2020 Year 01 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034404


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name