UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026089
Receipt No. 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

* 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 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
Institute QOL RD Co.,Ltd.
Institute
Department

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
URL(English) https://upload.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


Contact us.