UMIN-CTR Clinical Trial

Basic information
Public title	Effect of small dose of whey and soy protein hydrolysate on postprandial glucose level in young men: a randomized controlled crossover trial
Acronym	The effects of small dose of whey and soy protein hydrolysate on Postprandial Blood Glucose
Scientific Title	Effect of small dose of whey and soy protein hydrolysate on postprandial glucose level in young men: a randomized controlled crossover trial
Scientific Title:Acronym	The effects of small dose of whey and soy protein hydrolysate on Postprandial Blood Glucose
Region	Japan

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

Objectives
Narrative objectives1	soy and 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 glucagon level Blood C-peptide level Blood amino acid level

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	1. Whey protein hydrolysate ingestion a dose of 10g, 5 meals was performed over the two days 2. Wash out 1 week 3. Soy protein hydrolysate ingestion a dose of 10g, 5 meals was performed over the two days
Interventions/Control_2	1. Soy protein hydrolysate ingestion a dose of 10g, 5 meals was performed over the two days 2. Wash out 1 week 3. Whey protein hydrolysate ingestion a dose of 10g, 5 meals was performed over the two days
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
Key inclusion criteria	1)Subjects who can make self-judgment and are voluntarily giving written informed consent. 2)BMI range: 18.5-25.0 kg/m2
Key exclusion criteria	1. Who are not prohibited from exercising by a doctor. 2. Subjects who have diagnostic of mental disorder 3. Subjects who have steroid hormone drug regularly. 4. Subjects who have past surgical history of gastroenterological surgery. 5. Past medical history of kidney disease. 6. Subjects who use pharmaceuticals regularly. 7. Subjects who have an acute disease like a inflammation of the upper airway or acute gastroenteritis. 8. Subjects who excessive alcohol intake and who have a smoking habit. 9. Subjects who is irregular eating habits. 10. Subjects who are participating or will participate other clinical trials. 11. Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Kentaro Middle name Last name Kawanaka
Organization	Fukuoka University
Division name	Faculty of Sports and Health Science
Zip code	814-0180
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	1st name Yoichi Middle name Last name Hatamoto
Organization	Fukuoka University
Division name	Faculty of Sports and Health Science
Zip code	814-0180
Address	8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL	+81-92-871-6631
Homepage URL
Email	y.hatamoto.7@gmail.com

Sponsor
Institute	Fukuoka University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of Fukuoka University
Address	8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
Tel	092-871-6631
Email	pj.ca.u-akoukuf.mda@nisius

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	2019 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	8
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 04 Day
Date of IRB	2017 Year 09 Month 15 Day
Anticipated trial start date	2017 Year 11 Month 02 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 25 Day
Last modified on	2019 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042665