UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037481
Receipt number R000042665
Scientific Title Effect of small dose of whey and soy protein hydrolysate on postprandial glucose level in young men: a randomized controlled crossover trial
Date of disclosure of the study information 2019/12/31
Last modified on 2019/07/25 10:10:04

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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 or person

Institute

Fukuoka University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042665


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name