UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of ingestion of a food on glycometabolism A randomized, double blind, placebo-controlled study
Title of the study (Brief title)	Effects of ingestion of a food on glycometabolism
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to evaluate the effects of ingestion of a food on glycometabolism for japanese male and female between the ages of 20 years and 59 years.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	P1asma glucose, 2-hr PG, Insulin, TG, Glico albumin, Insulinogenic index, HOMA-IR
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
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	Ingestion of food for 12 consecutive weeks
Interventions/Control_2	Ingestion of placebo for 12 consecutive weeks
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	59 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Japanese male and female aged between 20 and 59 years (2)Subjects who have blood sugar level between 140 and 199mg/dL at 120 minutes after 75g glucose load by OGTT and high levels of fasting blood sugar and triglyceride. The investigator judge whether subjects who have blood sugar level of between 200 and 210mg/dL are included in this study or not.
Key exclusion criteria	(1)Subjects who are treating diabetes or dyslipidemia (2)Subjects who have a serious disease or health history (3)Subjects who have disability of the functions of the heart and the lungs (4)Subjects who were operated on the alimentary canal (5)Subjects who are treating illness at present (6)Subjects with food and medicine allergies (7)Subjects who take vigorous exercise or are on a diet
Target sample size	44

Research contact person
Name of lead principal investigator	Makoto Terashima
Organization	Oneness Support Co., Ltd.
Division name	Clinical trial Division
Address	Higashi-Tenma Building 8F, 1-7-17, Higashi Tenma, Kita-ku, Osaka
TEL	0648018917
Email	mterashima@oneness-sup.co.jp

Public contact
Name of contact person	Makoto Terashima
Organization	Oneness Support Co., Ltd.
Division name	Clinical trial Division
Address	Higashi-Tenma Building 8F, 1-7-17, Higashi Tenma, Kita-ku, Osaka
TEL	0648018917
Homepage URL
Email	shiken@oneness-sup.co.jp

Sponsor
Institute	Oneness Support Co., Ltd.
Institute
Department

Funding Source
Organization	FUJI OIL CO., LTD
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	みうらクリニック（大阪府）

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 24 Day
Anticipated trial start date	2014 Year 06 Month 23 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 06 Month 19 Day
Last modified on	2018 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016667