UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038630
Receipt number R000044011
Scientific Title Effects of a Test Food for Improvement of Skin Function.
Date of disclosure of the study information 2019/11/19
Last modified on 2021/05/21 14:28:50

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Basic information

Public title

Effects of a Test Food for Improvement of Skin Function.

Acronym

Effects of a Test Food for Improvement of Skin Function.

Scientific Title

Effects of a Test Food for Improvement of Skin Function.

Scientific Title:Acronym

Effects of a Test Food for Improvement of Skin Function.

Region

Japan


Condition

Condition

N/A(healthy adults)

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study examines effects of a test food for improvement of skin function.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

[1]Indexes for skin function (skin moisture content, transepidermal water loss) (Screening, Week 0, Week 8, Week 12).

Key secondary outcomes

*Secondary indexes
[1]Observation for skin condition by dermatologists (Screening, Week 0, Week 8, Week 12).
[2]Japanese Edition of Profile of Mood States (2nd edition) (Week 0, Week 8, Week 12).
[3]Visual Analogue Scale (Week 0, Week 8, Week 12).

*Safety
[1]Blood test (Screening, Week 0, Week 12).
[2]Blood biochemical test (Screening, Week 0, Week 12).
[3]Urine analysis (Screening, Week 0, Week 12).
[4]Blood pressure, pulsation (Screening, Week 0, Week 8, Week 12).
[5]Weight, body fat percentage, BMI (Screening, Week 0, Week 8, Week 12).
[6]Doctor's questions (Screening, Week 0, Week 8, Week 12).
[7]Subject's diary (From the first day of ingestion of a test material to the last day of the test).


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

Oral intake of the test food (1 stick / day; 12 weeks).

Interventions/Control_2

Oral intake of the placebo (1 stick / day; 12 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

60 years-old >

Gender

Male and Female

Key inclusion criteria

[1]Healthy Japanese females aged 30-59 years.
[2]Individuals who are healthy and have no chronic physical disease including skin disease.
[3]Individuals who are aware of skin dryness.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can have an examination on a designated check day.
[6]Individuals judged appropriate for the study by the principal.

Key exclusion criteria

[1]Individuals using medical products.
[2]Individuals with skin disease, such as atopic dermatitis.
[3]Individuals with strange skin conditions at measurement points.
[4]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis).
[5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[6]Individuals who contract or have a history of serious gastrointestinal disease.
[7]Individuals with serious anemia.
[8]Individuals whose BMI is over 30.0.
[9]Individuals who are sensitive to test product or other foods, and medical products.
[10]Individuals who have a habit to ingest foods similar with the test product.
[11]Individuals who had a habit to ingest health-promoting foods or supplements in the past 3 months or will ingest those foods during the test period.
[12]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[13]Individuals who are or are possibly pregnant, or are lactating.
[14]Individuals who take alcohol (expressed in an amount of alcohol: over 60mg/day).
[15]Individuals who are patient or have a history of psychiatric disease.
[16]Individuals who are a smoker.
[17] Individuals with possible changes of life style during the test period.
[18]Individuals who will develop seasonal allergy symptoms like hay fever and a drug.
[19]Individuals who neglect skin care.
[20]Individuals who cannot avoid daylight exposure during the test period.
[21]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[22]Individuals who had been conducted an operation on the test spot.
[23]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[24]Individuals who are or whose family is engaged in functional foods or cosmetics.
[25]Individuals judged inappropriate for the study by the principal.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Takahiro
Middle name
Last name Ono

Organization

Ueno-Asagao Clinic

Division name

Head

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6240-1162

Email

info@ueno-asagao.clinc


Public contact

Name of contact person

1st name Ryoma
Middle name
Last name Shimizu

Organization

TES Holdings Co., Ltd.

Division name

Administrative Department of Clinical Trials

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6801-8480

Homepage URL


Email

r.shimizu@tes-h.co.jp


Sponsor or person

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Hakkaisan Brewery Co., Ltd.

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

Ueno-Asagao Clinic Ethical Review Committee

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

Tel

+81-3-6240-1162

Email

jimukyoku@tes-h.co.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

2019 Year 11 Month 19 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

2019 Year 10 Month 21 Day

Date of IRB

2019 Year 10 Month 23 Day

Anticipated trial start date

2019 Year 12 Month 12 Day

Last follow-up date

2020 Year 04 Month 08 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 11 Month 19 Day

Last modified on

2021 Year 05 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044011


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name