UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of healthy adult males in a crossover comparison trial of postprandial blood glucose levels regarding noodles containing 0 grams of sugar and commercially available noodles.
Title of the study (Brief title)	A study of healthy adult males in a crossover comparison trial of noodles containing 0 grams of sugar vs commercially available noodles
Region	Japan

Condition
Condition	No
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Regarding postprandial blood glucose levels of humans for noodles containing 0 grams of sugar, it was found that postprandial blood glucose levels do not rise easily when compared with commercially available noodles.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood glucose level
Key secondary outcomes	Insulin

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	noodles containing 0 grams of sugar
Interventions/Control_2	commercially available noodles
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	35 years-old >=
Gender	Male
Key inclusion criteria	1)Healthy adult males Age:20 years old -35 years old 2)Blood glucose level:60-110mg/dL 3)Syphilis(-),HIV(-),HBsAg(-),HCV(-) 4)Written informed consent
Key exclusion criteria	1)People with an allergy towards wheat, soybean and ingredients from other experimental diets 2)People who regularly take supplements, health products and specified health foods that have an effect on blood sugar levels 3)People with Serious complications 4)People with Psychiatric disorder 5)People who participated in other trial within 4 months 6)People who judged inappropriate for this study by the treating physician
Target sample size	8

Research contact person
Name of lead principal investigator	Satoshi Tsunematsu
Organization	Kitasato University Kitasato Institute Hospital
Division name	Department of Research
Address	5-9-1 Shirokane, Minato-ku, Tokyo, Japan
TEL	03-5791-6350
Email	tunematu@insti.kitasato-u.ac.jp

Public contact
Name of contact person	Takaaki Takenaga
Organization	Kitasato Academic Research Organization, Kitasato University
Division name	Clinical Trial Coordinating Center
Address	5-9-1 Shirokane, Minato-ku, Tokyo, Japan
TEL	03-5791-6400
Homepage URL
Email	takena-t@insti.kitasato-u.ac.jp

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	KIBUN FOODS INC
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	北里大学北里研究所病院(東京都)

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 08 Day
Anticipated trial start date	2016 Year 10 Month 31 Day
Last follow-up date	2016 Year 11 Month 09 Day
Date of closure to data entry	2016 Year 11 Month 20 Day
Date trial data considered complete	2016 Year 11 Month 25 Day
Date analysis concluded	2016 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 09 Month 09 Day
Last modified on	2018 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027586