UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026089
Receipt number R000029979
Scientific Title Safety evaluation study of excessive intake beef cooked with soy sauce containing Salacia extract in adult men and women.
Date of disclosure of the study information 2018/03/06
Last modified on 2018/10/24 09:20:01

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Basic information

Public title

Safety evaluation study of excessive intake beef cooked with soy sauce containing Salacia extract in adult men and women.

Acronym

Safety evaluation study of excessive intake of food containing plant extract in adult men and women.

Scientific Title

Safety evaluation study of excessive intake beef cooked with soy sauce containing Salacia extract in adult men and women.

Scientific Title:Acronym

Safety evaluation study of excessive intake of food containing plant extract in adult men and women.

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To evaluate safety of excessive intake of food containing plant extract, 3-fold quantity of recommended daily intake for 4 weeks

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence of side effect

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


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of test food for 4 weeks, everyday

Interventions/Control_2

Intake of placebo food for 4 weeks, everyday

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.Healthy subjects aged from 20 to 64 years-old at the time of giving informed consent
2.Subjects whose fasting blood glucose is less than or equal to 125mg/dl at the time of giving informed consent
3.Subjects having no dietary restriction
4.Subjects neither attending the hospital as outpatients nor medicated
5.Subjects without serious liver disorder, renal disturbance, heart disease, cerebrovascular disease, organ derangement and allergic disease
6.Subjects who fully understand and agree with the objective of this study by prior oral explanation and are able to give informed consent written by themselves

Key exclusion criteria

1.Subjects having allergies for drugs and foods
2.Subjects who drink alcohol more than in terms of 500ml beer in a day.
3.Subjects who smoke more than 20 cigarettes on average in a day
4.Pregnant women, or women intending to be pregnant, and lactating women
5.Subjects who donated more than 200ml of blood within 1 month or more than 400ml of blood within 3 months prior to the study
6.Subjects who are participating in the other clinical trial
7.Subjects who don't follow the instructions from the doctor or the staff

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiko Fujisawa

Organization

Ageokousei Hospital

Division name

Director

Zip code


Address

421-1 , Jitoukata, Ageo-shi, Saitama

TEL

048-781-1101

Email

susumu.hosonuma@achs.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hitomi Nasu

Organization

QOL RD Co.,Ltd.

Division name

CRO Department Food Division

Zip code


Address

2-14-1, Nihonbashi, Chuo-Ku, Tokyo, Japan

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

Yoshinoya holdings

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

2018 Year 03 Month 06 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.toukastress.jp/webj/month/2017

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

2016 Year 12 Month 28 Day

Date of IRB


Anticipated trial start date

2017 Year 03 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



Management information

Registered date

2017 Year 02 Month 10 Day

Last modified on

2018 Year 10 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029979


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name