UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate the transition of growth hormone secretion by ingesting high protein processed food.
Acronym	A study to evaluate the transition of growth hormone secretion by ingesting high protein processed food.
Scientific Title	A study to evaluate the transition of growth hormone secretion by ingesting high protein processed food.
Scientific Title:Acronym	A study to evaluate the transition of growth hormone secretion by ingesting high protein processed food.
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we aimed to evaluate the transition of growth hormone secretion by ingesting high-protein food and loading walking exercise.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Growth hormone before and after walking
Key secondary outcomes	The following items before and after walking exercise. Cortisol, triglyceride, blood glucose, insulin, blood amino acids, degree of fatigue.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	From 1 day to 7 days, ingest high protein food. 8 to 14 days, ingest control food.
Interventions/Control_2
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	45 years-old >=
Gender	Male and Female
Key inclusion criteria	[1]Aged between 20 and 45 [2]Individuals who are healthy and do not treat any disease [3]Individuals whose written informed consent has been obtained [4]Individuals who can have an examination on a designated check day [5]Individuals judged appropriate for the study by the principal
Key exclusion criteria	[1]Individuals using medical products [2]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease,or blood disease [3]Individuals with serious anemia [4]Individuals who are sensitive to test products or Individual with fear who causes severe allergy in a food and medical supplies [5]Individuals who routinely take high protein food such as protein drinks and bars [6]Individual who is pregnant or lactate [7]Individuals who participated in other clinical studies in the past three months [8]Individuals judged inappropriate for the study by the principal
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Yoshikazu Middle name Last name Yonei
Organization	Faculty of Life and Medical Sciences,Doshisha University
Division name	Anti-Aging Medical Research Center
Zip code	6100394
Address	1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL	0774-65-6394
Email	yyonei@mail.doshisha.ac.jp

Public contact
Name of contact person	1st name Seigo Middle name Last name Isozaki
Organization	Anti-Aging Bank Co.,Ltd.
Division name	Clinical test support team
Zip code	1010054
Address	3-21,Kanda-nishikicho,Chiyoda-ku,Tokyo
TEL	03-5577-1010
Homepage URL
Email	isozaki@antiaging-bank.com

Sponsor
Institute	YOSHINOYA HOLDINGS CO., LTD.
Institute
Department

Funding Source
Organization	YOSHINOYA HOLDINGS 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	Society of Glycative Stress Research
Address	2-13-10-5F 11,Shinjuku,Shinjuku-ku,Tokyo
Tel	03-6709-8842
Email	rinri-glycativestress@antiaging-bank.com

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	浦田クリニック／スコール金沢（石川県）

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 07 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	12
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	2019 Year 01 Month 11 Day
Date of IRB	2019 Year 01 Month 21 Day
Anticipated trial start date	2019 Year 01 Month 23 Day
Last follow-up date	2019 Year 06 Month 30 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 01 Month 24 Day
Last modified on	2019 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040598