UMIN-CTR Clinical Trial

Basic information
Public title	Study of ingestion of protein powder
Acronym	Study of ingestion of protein powder
Scientific Title	Study of ingestion of protein powder
Scientific Title:Acronym	Study of ingestion of protein powder
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effect of test food on the body
Basic objectives2	Others
Basic objectives -Others	Absorption kinetics after food ingestion
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Plasma amino acids, BAP, d-ROMs, testosterone, glucose and irisin concentration and questionnaire
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of test food (1 week)
Interventions/Control_2	Ingestion of placebo food (1 week)
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	18 years-old <=
Age-upper limit	30 years-old >
Gender	Male
Key inclusion criteria	Male students belonging to University of Tsukuba who are healthy and not suffered from a chronic malady. Individuals whose written informed consent has been obtained.
Key exclusion criteria	Individuals who have possibility of allergy symptoms onset by the test food and who cause allergic symptoms in foods and medicines. Individuals who are a smoker. Individuals who have a habit to ingest food containing test food ingredients on a daily basis.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Naomi Middle name Last name Omi
Organization	University of Tsukuba
Division name	Faculty of Health and Sport Sciences
Zip code	305-8574
Address	1-1-1, Tennou dai, Tsukuba city
TEL	029-853-6319
Email	omi.naomi.gn@u.tsukuba.ac.jp

Public contact
Name of contact person	1st name Naomi Middle name Last name Omi
Organization	University of Tsukuba
Division name	Faculty of Health and Sport Sciences
Zip code	305-8574
Address	1-1-1, Tennou dai, Tsukuba city
TEL	029-853-6319
Homepage URL
Email	omi.naomi.gn@u.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	MORINAGA & 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	Research ethics committee,Faculty of Health and Sport Sciences,University of Tsukuba
Address	1-1-1 Tennodai, Tsukuba,Ibaraki
Tel	029-853-2571
Email	tg-kenkyurinri@un.tsukuba.ac.jp

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	2022 Year 01 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	2021 Year 11 Month 02 Day
Date of IRB	2021 Year 12 Month 22 Day
Anticipated trial start date	2022 Year 01 Month 20 Day
Last follow-up date	2023 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	2022 Year 01 Month 20 Day
Last modified on	2022 Year 07 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053133