UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating the effect of the intake of meal containing Salacia extract on postprandial hyperglycemia.
Title of the study (Brief title)	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	Kazuhiko Fujisawa
Organization	Ageokousei Hospital
Division name	Director
Address	421-1 , Jitoukata, Ageo-shi, Saitama
TEL	048-781-1101
Email	masayuki.nakamura@achs.jp

Public contact
Name of contact person	Hitomi Nasu
Organization	QOL RD Co.,Ltd.
Division name	CRO Department Food Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.toukastress.jp/webj/month/2017/page-2
Results
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