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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
