UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022283 |
|---|---|
| Receipt number | R000025677 |
| Scientific Title | A study for evaluating the effect of the intake of meal containing Salacia extract on postprandial hyperglycemia. |
| Date of disclosure of the study information | 2017/06/18 |
| Last modified on | 2018/10/24 09:18:36 |
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Basic information
Public title
A study for evaluating the effect of the intake of meal containing Salacia extract on postprandial hyperglycemia.
Acronym
A study for evaluating the effect of the intake of meal containing plant extract on postprandial hyperglycemia.
Scientific Title
A study for evaluating the effect of the intake of meal containing Salacia extract on postprandial hyperglycemia.
Scientific Title:Acronym
A study for evaluating the effect of the intake of meal containing plant extract on postprandial hyperglycemia.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of an plant extract containing meal on postprandial hyperglycemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postprandial blood glucose
Area under the curve of plasma glucose
Key secondary outcomes
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
Test meal with plant extract (single ingestion)-washout period- placebo meal without plant extract (single ingestion)
Interventions/Control_2
placebo meal without plant extract (single ingestion) -washout period- Test meal with 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Fasting blood glucose >=100,and <125mg/dl
2.Subjects who don't have drink alcohol over 25g/day
3.Subjects having no habit of any restriction of food
4.Subjects who don't going to hospital, medicine for present treatment
5.Subjects, upon briefing of the content of the present study, fully understands and agrees to its objective and is able to personally give written informed consent
Key exclusion criteria
1.Subjects having possibilities for emerging allergy related to the study
2.Pregnant women, or women with intending to become pregnant, and lactating woman.
3.Person who donated more than 200ml of blood within 1 month or 400ml of blood within 3 months prior to the study
4.Subjects who is participating in another clinical trial
5.Subjects who don't follow the instructions from the doctor or the staff
6.Subjects judged by the doctor to be unsuitable
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
masayuki.nakamura@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
| 2017 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.toukastress.jp/webj/month/2017/page-2
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 | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 12 | 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
| 2016 | Year | 05 | Month | 11 | 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=R000025677
