UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025151
Receipt number R000028925
Scientific Title Effects of single ingestion of food containing amla fruit extract on blood flow and body surface temperature
Date of disclosure of the study information 2018/02/28
Last modified on 2019/01/10 11:39:42

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Basic information

Public title

Effects of single ingestion of food containing amla fruit extract on blood flow and body surface temperature

Acronym

Effects of single ingestion of food containing amla fruit extract on blood flow and body surface temperature

Scientific Title

Effects of single ingestion of food containing amla fruit extract on blood flow and body surface temperature

Scientific Title:Acronym

Effects of single ingestion of food containing amla fruit extract on blood flow and body surface temperature

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigation of blood flow and body surface temperature effects of food containing amla fruit extract

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Body surface temperature (first observation, second observation)

Key secondary outcomes

Blood flow (first observation, second observation)


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


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Oral intake of the food containing amla fruit extract (1 time)

Interventions/Control_2

Oral intake of placebo food (1 time)

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

Female

Key inclusion criteria

1) Healthy females who are age from 20 to 64.
2) Subjects who are sensitive to the cold

Key exclusion criteria

1) Subjects who have the habit of taking test food.
2) Subjects who have the habit of taking healthcare products.
3) Patients who have serious disease or subjects who have serious disease history.
4) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination.
5) Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period.
6) Subjects who are participated in other clinical studies.
7) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
8) Subjects who are judged unfit to enroll in this trial by the investigator.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsutomu Okubo

Organization

Taiyo Kagaku Co., Ltd.

Division name

Nutrition division

Zip code


Address

1-3, Takara-cho, Yokkaichi-shi, Mie, 510-0844, JAPAN

TEL

059-347-5411

Email

tohkubo@taiyokagaku.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Zenta Yasukawa

Organization

Taiyo Kagaku Co., Ltd.

Division name

Nutrition division

Zip code


Address

1-3, Takara-cho, Yokkaichi-shi, Mie, 510-0844, JAPAN

TEL

059-347-5411

Homepage URL


Email

zyasukawa@taiyokagaku.co.jp


Sponsor or person

Institute

TTC Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

2018 Year 02 Month 28 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

The ingestion of amla extract accelerated recovery of body surface temperature and blood flow following cold water stress compared to placebo group.

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

2016 Year 12 Month 03 Day

Date of IRB


Anticipated trial start date

2016 Year 12 Month 06 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Jpn Pharmacol Ther 46(2), 227-235, 2018
Jpn Pharmacol Ther 46(8), 1456, 2018


Management information

Registered date

2016 Year 12 Month 05 Day

Last modified on

2019 Year 01 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028925


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name