UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000052046
Receipt number R000059406
Scientific Title A study on the amount of food-derived collagen peptides in the urine of Japanese young women
Date of disclosure of the study information 2023/09/20
Last modified on 2024/09/04 18:10:44

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Basic information

Public title

A study on the amount of food-derived collagen peptides in the urine of Japanese young women

Acronym

A study on the food-derived collagen peptides in the urine of Japanese women

Scientific Title

A study on the amount of food-derived collagen peptides in the urine of Japanese young women

Scientific Title:Acronym

A study on the food-derived collagen peptides in the urine of Japanese women

Region

Japan


Condition

Condition

healthy women

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To obtain basic knowledge on nutritional dynamics by studying the relationship between the dietary intake and the constituents in 24-hour urine.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relationship between 24-hour urinary constituents and dietary intake.

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

18 years-old <=

Age-upper limit

65 years-old >

Gender

Female

Key inclusion criteria

Participants with no loss in data

Key exclusion criteria

Participants with incomplete data

Target sample size



Research contact person

Name of lead principal investigator

1st name Tomoko
Middle name
Last name Asai

Organization

Nara Women's Unniversity

Division name

Faculty of Human Life and Environment

Zip code

630 8506

Address

Ki

TEL

0742203453

Email

asai@cc.nara-wu.ac.jp


Public contact

Name of contact person

1st name Tomoko
Middle name
Last name Asai

Organization

Nara Women's Unniversity

Division name

Faculty of Human Life and Environment

Zip code

630 8506

Address

Kitauoyanishimachi, Nara-shi, Nara-ken, Japan

TEL

0742203453

Homepage URL


Email

asai@cc.nara-wu.ac.jp


Sponsor or person

Institute

Nara Women's Unniversity

Institute

Department

Personal name

Tomoko Asai


Funding Source

Organization

Nara Women's Unniversity

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nara Women's Unniversity

Address

Kitauoyanishimachi, Nara-shi, Nara-ken, Japan

Tel

0742203543

Email

asai@cc.nara-wu.ac.jp


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

2023 Year 09 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


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

Enrolling by invitation

Date of protocol fixation

2021 Year 08 Month 15 Day

Date of IRB

2021 Year 02 Month 10 Day

Anticipated trial start date

2022 Year 04 Month 15 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The relationship between 24-hour urinary constituents and dietary intake will be discussed.
Samples and data were from those stored at their institutions.


Management information

Registered date

2023 Year 08 Month 29 Day

Last modified on

2024 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059406


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name