UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021108 |
|---|---|
| Receipt number | R000024313 |
| Scientific Title | Estimation of effective intake of whey protein hydrolysate for stimulating muscle protein synthesis by using blood components as markers |
| Date of disclosure of the study information | 2016/02/20 |
| Last modified on | 2016/08/19 17:43:53 |
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Basic information
Public title
Estimation of effective intake of whey protein hydrolysate for stimulating muscle protein synthesis by using blood components as markers
Acronym
Estimation of effective intake of whey protein hydrolysate for stimulating muscle protein synthesis
Scientific Title
Estimation of effective intake of whey protein hydrolysate for stimulating muscle protein synthesis by using blood components as markers
Scientific Title:Acronym
Estimation of effective intake of whey protein hydrolysate for stimulating muscle protein synthesis
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the effective intake of whey protein hydrolysate for stimulating muscle protein synthesis by using blood components as markers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma leucine concentration 0-120 min after ingestion of whey protein hydrolysate or essential amino acids
Key secondary outcomes
1)Plasma concentration of the following items 0-120 min after ingestion of whey protein hydrolysate or essential amino acids; essential amino acids, insulin, IGF-1 and 3-methyl-histidine
2)Blood glucose level 0-120 min after ingestion of whey protein hydrolysate or essential amino acids
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
They ingest the following foods one time in the following order more than six days apart; 7.5 g whey protein hydrolysate (WPH), 5.0 g WPH, 2.5 g WPH and 2.5 g essential amino acids
Interventions/Control_2
They ingest the following foods one time in the following order more than six days apart; 5.0 g whey protein hydrolysate (WPH), 2.5 g essential amino acids, 7.5 g WPH and 2.5 g WPH
Interventions/Control_3
They ingest the following foods one time in the following order more than six days apart; 2.5 g whey protein hydrolysate (WPH), 7.5 g WPH, 2.5 g essential amino acids and 5.0 g WPH
Interventions/Control_4
They ingest the following foods one time in the following order more than six days apart; 2.5 g essential amino acids, 2.5 g whey protein hydrolysate (WPH), 5.0 g WPH and 7.5 g WPH
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
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy men not less than 20 years old and under 30 years old
Key exclusion criteria
1) Seriously or progressive ill patients
2) Patients with liver or kidney dysfunction
3) Patients with food allergies
4) Patients with congenital aminoacidopathy
5) HBsAg or HCVAb positive patients
6) Persons who donated blood within 3 months
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuji Ikegami |
Organization
Meiji Co., Ltd.
Division name
Sports Nutrition Research Department Food Science Research Laboratories R&D Division
Zip code
Address
540 Naruda, Odawara, Kanagawa 250-0862, Japan
TEL
+81-465-37-3796
shuuji.ikegami@meiji.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiaki Sanbongi |
Organization
Meiji Co., Ltd.
Division name
Sports Nutrition Research Department Food Science Research Laboratories R&D Division
Zip code
Address
540 Naruda, Odawara, Kanagawa 250-0862, Japan
TEL
+81-465-37-3796
Homepage URL
chiaki.sanbongi@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
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
CPCC Co., Ltd.
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
チヨダパラメディカルケアクリニック
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 20 | 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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 06 | Month | 23 | Day |
Date analysis concluded
| 2016 | Year | 07 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 19 | 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=R000024313
