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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035656
Receipt No. R000040598
Official scientific title of the study A study to evaluate the transition of growth hormone secretion by ingesting high protein processed food.
Date of disclosure of the study information 2019/02/07
Last modified on 2019/01/24

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Basic information
Official scientific title of the study A study to evaluate the transition of growth hormone secretion by ingesting high protein processed food.
Title of the study (Brief title) 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 Yoshikazu Yonei
Organization Faculty of Life and Medical Sciences,Doshisha University
Division name Anti-Aging Medical Research Center
Address 1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL 0774-65-6394
Email yyonei@mail.doshisha.ac.jp

Public contact
Name of contact person Seigo Isozaki
Organization Anti-Aging Bank Co.,Ltd.
Division name Clinical test support team
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 01 Month 11 Day
Anticipated trial start date
2019 Year 01 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2019 Year 01 Month 24 Day
Last modified on
2019 Year 01 Month 24 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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