UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044784
Receipt number R000051151
Scientific Title Effect of ingestion of fermented milk food on the skin in healthy subjects
Date of disclosure of the study information 2021/07/07
Last modified on 2022/06/13 13:42:23

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Basic information

Public title

Effect of ingestion of fermented milk food on the skin in healthy subjects

Acronym

Effect of ingestion of fermented milk food on the skin

Scientific Title

Effect of ingestion of fermented milk food on the skin in healthy subjects

Scientific Title:Acronym

Effect of ingestion of fermented milk food on the skin

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate effects of fermented milk food on the skin in healthy adults

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Corneous moisture content

Key secondary outcomes

Skin elasticity, Transepidermal water loss


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

8weeks
Placebo food
Once a day

Interventions/Control_2

8weeks
Fermented milk food
Once a day

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

59 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy adults

Key exclusion criteria

1.Persons who consume functional foods or medicines that affect the skin
2.Persons who experienced cosmetic medicine or hormone replacement therapy
3.Persons who have undergone esthetic treatment on the skin of the measurement site during the month before this trial
4.Persons who got browned for a long time
5.Persons who have a habit to wash body strongly
6.Persons who have scratches or inflammations the skin of the measurement site
7.Persons who occur skin disorders before and after a menstrual period
8.Persons of irregular habits
9.Persons who have food allergies for test foods
10.Persons who have serious conditions
11.Persons who have a plan to participate in other clinical study during current study
12.Persons who are pregnant or may become pregnant
13.Other persons who are judged by the investigator to be inappropriate for this study

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Kentaro
Middle name
Last name Shoji

Organization

Otsuma Women's University

Division name

Department of Food Science, Faculty of Home Economics

Zip code

102-8357

Address

12 Sanban-cho,Chiyoda-ku,Tokyo

TEL

0352756086

Email

shoji@otsuma.ac.jp


Public contact

Name of contact person

1st name Kentaro
Middle name
Last name Shoji

Organization

Otsuma Women's University

Division name

Department of Food Science, Faculty of Home Economics

Zip code

102-8357

Address

12 Sanban-cho,Chiyoda-ku,Tokyo

TEL

0352756086

Homepage URL


Email

shoji@otsuma.ac.jp


Sponsor or person

Institute

Otsuma Women's University

Institute

Department

Personal name



Funding Source

Organization

Milk Lab. Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical review committee of Otsuma Women's University

Address

12 Sanban-cho,Chiyoda-ku,Tokyo

Tel

0352756408

Email

kenkyu.s@ml.otsuma.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

2021 Year 07 Month 07 Day


Related information

URL releasing protocol

Unpublished due to the protocol including the intellectual property rights

Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

40

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

2021 Year 04 Month 20 Day

Date of IRB

2021 Year 06 Month 07 Day

Anticipated trial start date

2021 Year 06 Month 08 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 07 Month 07 Day

Last modified on

2022 Year 06 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051151


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name