UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000016587
Receipt No. R000019242
Scientific Title Influence of collagen intake on growth hormone
Date of disclosure of the study information 2015/02/20
Last modified on 2019/05/13 (Ver. 11)

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Basic information
Public title Influence of collagen intake on growth hormone
Acronym Influence of collagen intake on growth hormone
Scientific Title Influence of collagen intake on growth hormone
Scientific Title:Acronym Influence of collagen intake on growth hormone
Region
Japan

Condition
Condition Healthy Adult
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to examine the influence of collagen intake on growth hormone, blood test, skin water content, skin elasticity, DermaLab (an equipment brought by client and measured with by SOUKEN staff) 1, skin condition photography with VISIA-Evolution and questionnaire survey are evaluated in a placebo-controlled double-blind comparative study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Growth hormone(GH)
Key secondary outcomes IGF-1 (somatomedin C)
Amino acid analysis (41 types) (amino acids fractionation)
Measurement of skin conditions (elasticity and water content of the skin, DermaLab, VISIA-Evolution)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 8week
2pack per day
Once a day
Administer study drugs to subjects within 8 weeks.
Interventions/Control_2 8week
2pack per day
Once a day
Administer placebo to subjects within 8 weeks.
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
30 years-old <=
Age-upper limit
39 years-old >=
Gender Female
Key inclusion criteria -Japanese females aged 30-39
-A person who feels skin roughness.
Key exclusion criteria -A person who is judged inappropriate to join the study by doctor in charge.
-A person with arrhythmia and severe anemia.
-A person who is using blood-coagulation inhibitor (e.g. warfarin).
-A person who has anemia symptom (e.g. dizziness, lightheadedness, headache, palpitations, short of breath) everyday.
-A person that quantity of total drawn blood is more than 400mL within three months or more than 200mL within two months before this study.
-A person who is pregnant, could be pregnant in near future, or is breast feeding.
-A person who possibly shows allergy symptom due to test products ingredient.
-A person who is alcohol dependence.
-A person who is routinely taking a health food
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name Takashi
Middle name
Last name Koikeda
Organization Shiba Palace Clinic
Division name Chair
Zip code 105-0013
Address 6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 03-5408-1599
Email jimukyoku@mail.souken-r.com

Public contact
1st name of contact person
1st name ko
Middle name
Last name masuda
Organization SOUKEN Co., Ltd
Division name Management Division
Zip code 105-0013
Address 3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013,
TEL 03-5406-1555
Homepage URL
Email k_masuda@mail.souken-r.com

Sponsor
Institute Shiba Palace Clinic
Institute
Department

Funding Source
Organization FUJIFILM Corporation
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shiba Palace Clinic Ethics Review Committee
Address 6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel 03-5408-1590
Email shiba_palace@s-palace-clinic.com

Secondary IDs
Secondary IDs YES
Study ID_1 FJFR-16232
Org. issuing International ID_1 SOUKEN Co.,Ltd.
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 芝パレスクリニック（東京都）

Other administrative information
Date of disclosure of the study information
2015 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 24
Results 
A tendency to increase the serum GH by ingestion of collagen was observed.
Results date posted
2019 Year 05 Month 13 Day
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
2015 Year 08 Month 17 Day
Date of IRB
2015 Year 01 Month 08 Day
Anticipated trial start date
2015 Year 09 Month 29 Day
Last follow-up date
2015 Year 10 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
2015 Year 02 Month 20 Day
Last modified on
2019 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019242