UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016587 |
|---|---|
| Receipt number | 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 13:17:42 |
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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
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
jimukyoku@mail.souken-r.com
Public contact
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
k_masuda@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019242
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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