UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022863 |
|---|---|
| Receipt number | R000026349 |
| Scientific Title | A Study on the Effect of whey protein hydrolysate on Postprandial Blood Glucose |
| Date of disclosure of the study information | 2016/06/24 |
| Last modified on | 2016/08/19 11:05:51 |
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Basic information
Public title
A Study on the Effect of whey protein hydrolysate on Postprandial Blood Glucose
Acronym
The Effect of whey protein hydrolysate on Postprandial Blood Glucose
Scientific Title
A Study on the Effect of whey protein hydrolysate on Postprandial Blood Glucose
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kentaro Kawanaka |
Organization
Fukuoka University
Division name
Faculty of Sports and Health Science
Zip code
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 | |
| Middle name | |
| Last name | Shihoko Nakashima |
Organization
Fukuoka University
Division name
Faculty of Sports and Health Science
Zip code
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL
+81-92-871-6631
Homepage URL
shihoko@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 06 | Month | 21 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026349
