UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study on the Effect of whey protein hydrolysate on Postprandial Blood Glucose
Title of the study (Brief title)	The Effect of whey protein hydrolysate on Postprandial Blood Glucose
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore inhibitory effect of whey protein hydrolysate on postprandial blood glucose level.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postprandial blood glucose level
Key secondary outcomes	Blood insulin level Blood C-peptide level Blood total amino acid level Blood BCAA level

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Whey protein hydrolysate, single ingestion. Wash out 1 week. Placebo, single ingestion
Interventions/Control_2	Placebo, single ingestion. Wash out 1 week. Whey protein hydrolysate, 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	40 years-old <=
Age-upper limit	60 years-old >
Gender	Male
Key inclusion criteria	1) Subjects who can make self-judgment and are voluntarily giving written informed consent. 2) Males whose age 40 to 59 years old and meet the following conditions (1) and/or (2) at the day of screening test. (1) Fasting blood glucose level is 100mg/dL to less than 126 mg/dL. (2) HbA1c value is 5.8 to less than 6.5% (NGSP).
Key exclusion criteria	1) Seriously or progressive ill patients 2) Subjects who use pharmaceuticals regularly. 3) Subjects with food allergies 4) Subjects who excessive alcohol intake. (intake over 60g alcohol per day) 5) Subjects who have a smoking habit. 6) Subjects who donated 400 mL of blood within 12 weeks. Subjects who donated 200 mL of blood within 4 weeks. Subject who donated platelet blood within 2weeks. 7) Fasting blood glucose level over 126mg/dL, or HbA1c over 6.5% at the day of screening test. 8) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	10

Research contact person
Name of lead principal investigator	Kentaro Kawanaka
Organization	Fukuoka University
Division name	Faculty of Sports and Health Science
Address	8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL	+81-92-871-6631
Email	kawanaka@fukuoka-u.ac.jp

Public contact
Name of contact person	Shihoko Nakashima
Organization	Fukuoka University
Division name	Faculty of Sports and Health Science
Address	8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL	+81-92-871-6631
Homepage URL
Email	shihoko@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University
Institute
Department

Funding Source
Organization	Meiji 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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 24 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 06 Month 21 Day
Anticipated trial start date	2016 Year 08 Month 14 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 06 Month 23 Day
Last modified on	2016 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026349