臨床研究等提出・公開システム

Japanese

Date of registration	Feb. 10, 2016
Last modified on	Feb. 18, 2019
Trial ID	jRCT1090220244

Scientific Title	Effect of the single administration of functional carbohydrate on plasma biomarkers : a single-blind, cross-over study (Allu trial to lipid)
Public Title	Effect of the single administration of functional carbohydrate on plasma biomarkers

Study end date
Performed Number of Subjects
Baseline Characteristics
Participant Flow
Safety Conclusions
Efficacy Conclusions
Discussion and Overall Conclusions
Posted Date
Date of First Publication
Results Links

Plan to Share IPD
Plan Description
Protocol Links

Contact for Scientific Queries	Investigator Name	Kazuhiko Takano
	Investigator Organization	Medical Corporation Hokubukai Utsukushigaoka Hospital
	Address	61-1, Shinei, Kiyota-ku, Sapporo, 004-0839, Japan
	TEL	+81-11-882-8881
	E-mail	noriko-hayashi@matsutani.co.jp
Contact for Public Queries	Contact Name	Noriko Hayashi
	Contact Organization	Matsutani Chemical Industry Co., Ltd.
	Address	5-3, Kita-Itami, Itami City, Hyogo 664-8508, Japan
	TEL	+81-72-771-2052
	E-mail	noriko-hayashi@matsutani.co.jp

Recruitment Status	COMPLETED

Date of First Enrollment		Feb. 23, 2016
Planned Number of Subjects		14
Nature of Investigation		Interventional
Study Design	Description of Trial Design	single-blind, cross-over study
	Type of Control
	Trial Blinding Schema	single blind
	Randomized	Yes
Trial Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	Borderline diabetic: Screened based on fasting blood glucose levels from 110 mg/dl and below 126 mg/dl, or HbA1c(NGSP) levels from 6.2% and below 6.5%. High LDL-C subject: LDL-C levels from 120 mg/dl and below 160 mg/dl.
	Exclusion Criteria	1. Individuals suffering from serious diseases 2. Individuals had intestinal surgeries 3. Individuals using medications to control blood glucose and lipid levels 4. Individuals how are allergic to oligosaccharides and sweeteners 5. Individuals using functional foods to control blood glucose and lipid levels 6. Individuals participate in other clinical trials (food material, medicine, cosmetics, liniment)
	Minimum Age	20age old over
	Maximum Age	65age old not
	Sex of Participants	Male
Trial Indication(s)		Borderline diabetic: Screened based on fasting blood glucose levels from 110 mg/dl and below 126 mg/dl, or HbA1c(NGSP) levels from 6.2% and below 6.5%. High LDL-C subject: LDL-C levels from 120 mg/dl and below 160 mg/dl.
Intervention(s)		Intervention type:DRUG,BEHAVIOUR Name of intervention:allulose Dose form / Japanese Medical Device Nomenclature:SYRUP Route of administration / Site of application:ORAL Dose per administration:5g, 15g Dosing frequency / Frequency of use:ONCE Planned duration of intervention: Intended dose regimen:Intake of allulose : erythritol 5 : 10 or 15 : 0 before the meal detailes of teratment arms: Comparative intervention name:Erythritol Dose form / Japanese Medical Device Nomenclature:SYRUP Route of administration / Site of application:ORAL Dose per administration:15g Dosing frequency / Frequency of use:ONCE Planned duration of intervention: Intended dose regimen:Intake of allulose : erythritol 0 : 15 before the meal
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Serum lipids of up to 24 hours after ingestion (triglyceride, cholesterol, apoprotein)
Secondary Outcome(s)		Blood glucose and insulin levels of up to 24 hours after ingestion

Primary Sponsor	Matsutani Chemical Industry Co., Ltd.
Secondary Sponsor

Sources of funding	Matsutani Chemical Industry Co., Ltd.

Name of Ethics Committee	Utsukushigaoka Hospital ethics committee
Address
TEL
FAX
E-Mail
Ethics Committee Website
Committee Approval Number
Approved by Ethics Committee	Yes
Reason for Unapproval

Date of approved	Jan. 14, 2016

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Secondary Study ID	JMA-IIA00244
Issuer Name

Countrie(s) of Recruitment	Japan

History of Changes

No	Publication date
2	Feb. 18, 2019	(this page)	Changes
1	Feb. 10, 2016	Detail

List of change history