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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022283
Receipt No. 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

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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&#39;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
Email 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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025677

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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