UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Sucrose tolerance test for human after intake of yogurt with blood glucose elevation inhibitory effect
Title of the study (Brief title)	Sucrose tolerance test after intake of yogurt
Region	Japan

Condition
Condition	Diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of yogurt on postprandial hyperglycemia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postprandial blood glucose levels Area under the curve (AUC) of postprandial plasma glucose levels
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Sucrose tolerance test is conducted under the conditions of both yogurt intake(single ingestion 200ml) and no yogurt intake at an interval of 2days or more.
Interventions/Control_2	Sucrose tolerance test is conducted under the conditions of both yogurt intake(single ingestion 200ml) and no yogurt intake at an interval of 2days or more.
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	1) Subject who are the age of 20 to less than the age of 60 years old. 2) Healthy adult Male and Female 3) Subjects who can make self-judgment and are voluntarily giving written informed consent
Key exclusion criteria	1) Diabetes patients on treatment 2) Subjects who have dairy products allergy. 3) Subjects who use oral medication and constantly consume supplements affecting blood glucose. 4) Subjects who constantly use pharmaceuticals for chronic malady. 5) Subjects who have a history of digestive disease affecting digestion and absorption. 6) Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Target sample size	10

Research contact person
Name of lead principal investigator	Setsuo Hasegawa
Organization	Pharmaspur Inc.
Division name	Pharmaspur Inc.
Address	Toyo Building, 1-2-10 Nihonbashi, Chuo-ku, Tokyo
TEL	03-6214-2670
Email	setsuo_hasegawa@pharmaspur.com

Public contact
Name of contact person	Michiko Kaiuma
Organization	Pharmaspur Inc.
Division name	Pharmaspur Inc.
Address	Toyo Building, 1-2-10 Nihonbashi, Chuo-ku, Tokyo
TEL	03-6214-2670
Homepage URL
Email	michiko_kainuma@pharmaspur.com

Sponsor
Institute	Pharmaspur Inc.
Institute
Department

Funding Source
Organization	University of Tokyo
Organization
Division
Category of Funding Organization	Other
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	2016 Year 01 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 27 Day
Anticipated trial start date	2016 Year 01 Month 31 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	2016 Year 01 Month 30 Day
Last modified on	2017 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024021