UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026083 |
|---|---|
| Receipt number | R000029975 |
| Scientific Title | Safety evaluation study of long-term intake beef cooked with soy sauce containing Salacia extract in adult men and women. |
| Date of disclosure of the study information | 2018/02/13 |
| Last modified on | 2018/10/24 09:19:27 |
* 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 long-term intake beef cooked with soy sauce containing Salacia extract in adult men and women.
Acronym
Safety evaluation study of long-term intake of food containing plant extract in adult men and women.
Scientific Title
Safety evaluation study of long-term intake beef cooked with soy sauce containing Salacia extract in adult men and women.
Scientific Title:Acronym
Safety evaluation study of long-term 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
NO
Objectives
Narrative objectives1
To evaluate safety of intake of food containing plant extract for 12 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 12 weeks, everyday
Interventions/Control_2
Intake of placebo food for 12 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
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
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
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 | 13 | 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 | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 13 | 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=R000029975
