UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034058
Receipt No. R000038821
Scientific Title Effect of intake of supplement containing peptide collagen on adults.
Date of disclosure of the study information 2018/09/06
Last modified on 2019/03/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect of intake of supplement containing peptide collagen on adults.
Acronym Clinical trial of peptide collagen.
Scientific Title Effect of intake of supplement containing peptide collagen on adults.
Scientific Title:Acronym Clinical trial of peptide collagen.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy of intake of supplement containing peptide collagen for improving mental health in adult
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Profile of Mood States
Cancer Fatigue Scale
Key secondary outcomes The Pittsburgh Sleep Quality Index

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
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 To intake supplements containing peptide collagen
1 tablets /day for 4 weeks.
Interventions/Control_2 To intake placebo 1 tablets / day for 4 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Persons who is generally judged as healthy
(2) Persons who feel sleepy or stress during the day
(3) Persons who can give voluntary written consent to participate in the present trial
Key exclusion criteria (1)Persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study
(2)Persons who have changed their habitats to take supplements within past 4 weeks.
(3)Persons who work in night shift or in day and night shift
(4)Persons who have been treated their illness or prevention in a clinic at their informed consent
(5)Persons with their medical histories as follows: serious diseases of sugar metabolism, lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system
(6)Persons with the medical histories of alcoholism or drug dependence
(7)Persons who might be developed allergic reaction to foods.
(8)Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period
(9)Persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device)
(10)Persons who will not be judged suitable to the participants by the investigator.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kuniyoshi Shimizu
Organization Faculty of Agriculture, Kyushu University
Division name Laboratory of Systematic Forest and Forest Products Science
Zip code
Address 744 Motooka, Nishi-ku, Fukuoka, Fukuoka, JAPAN
TEL 0928024673
Email shimizu@agr.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kuniyoshi Shimizu
Organization Faculty of Agriculture, Kyushu University
Division name Laboratory of Systematic Forest and Forest Products Science
Zip code
Address 744, Motooka,Nishi-ku, Fukuoka, Fukuoka, JAPAN
TEL 0928024673
Homepage URL
Email shimizu@agr.kyushu-u.ac.jp

Sponsor
Institute Faculty of Agriculture, Kyushu University
Institute
Department

Funding Source
Organization UHA MIKAKUTOU CO.,LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Faculty of Humanity-Oriented Science and Engineering, Kindai University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 09 Month 06 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
2018 Year 08 Month 07 Day
Date of IRB
2018 Year 09 Month 15 Day
Anticipated trial start date
2018 Year 09 Month 15 Day
Last follow-up date
2018 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 01 Month 25 Day

Other
Other related information

Management information
Registered date
2018 Year 09 Month 06 Day
Last modified on
2019 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038821

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.