UMIN-CTR Clinical Trial

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

N/A(healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study examines effects of a jelly food containing glucosylceramide on improvement of skin function.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]Transepidermal water loss (Screening #1, Screening #2 & Week 0, Week 4, Week 8, Week 12)
[2]Skin moisture content (Screening #1, Screening #2 & Week 0, Week 4, Week 8, Week 12)
[3]Skin viscoelasticity (Screening #2 & Week 0, Week 4, Week 8, Week 12)
[4]Visual evaluation (Screening #2 & Week 0, Week 4, Week 8, Week 12)
[5]Questionnaire survey on skin condition (Screening #2 & Week 0, Week 4, Week 8, Week 12)

Key secondary outcomes

[1]Blood pressure, pulsation (Screening #2 & Week 0, Week 4, Week 8, Week 12)
[2]Weight, body fat percentage, BMI (Screening #2 & Week 0, Week 4, Week 8, Week 12)
[3]Doctor's questions (Screening #2 & Week 0, Week 4, Week 8, Week 12)
[4]Subject's diary(From the first day of ingestion of a test material to the last day of the test)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Oral ingestion of a test product containing glucosylceramide (10g per a day; 12 weeks)

Interventions/Control_2

Oral ingestion of a placebo not containing glucosylceramide (10g per a 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

Age-lower limit

30

years-old

<=

Age-upper limit

60

years-old

>

Gender

Female

Key inclusion criteria

[1]Japanese females aged 30-60 years
[2]Individuals who are healthy and are not suffered from a chronic malady
[3]Individuals who are anxious about skin dryness, sag, and tone
[4]Individuals whose written informed consent has been obtained
[5]Individuals who can visit an inspection facility and be inspected in designated days
[6]Individuals judged appropriate for the study by the principal

Key exclusion criteria

[1]Individuals using medical products
[2]Individuals who use a drug to treat a disease
[3]Individuals who contract or have a history of serious hepatopathy, kidney damage, heart disease and blood disease
[4]Individuals who contract or have a history of serious endocrine disease
[5]Individuals whose systolic blood pressure is over 160mmHg or diastolic pressure is over 100mmHg
[6]Individuals whose BMI is over 30
[7]Individuals with serious anemia
[8]Individuals who are sensitive to a test product or other foods, and medical products
[9]Individuals who are or are posslibly, or are lactating
[10]Individuals who have addiction to alcohol
[11]Individuals who have a habit of smoking
[12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day)
[13]Individuals whose bowel habit is irregular
[14]Individuals whose life style will change during the test period
[15]Individuals whose skin is sensitive or who is chronically red-faced
[16]Individuals with skin disease, such as atopic dermatitis
[17]Individuals who would emerge seasonal allergay and use drugs (except eye drops and nose drops)
[18]Individuals who is too sensitive to cold
[19]Individuals who is busy to their own work, housework or child care and neglect skin care
[20]Individuals who cannot avoid daylight exposure during the test period
[21]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments in the past 3 months or will ingest those foods during the test period
[22]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months
[23]Individuals who use cosmetics having a strong moisturizing effect or improvintg effect for wrinkle
[24]Individuals who had been conducted an operation on the test spot
[25]Individuals who participated in other clinical studies in the past 3 months
[26]Individuals judged inappropriate for the study by the principal

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Shuji Nakata

Organization

Medical Corporation Bokushinkai CLINTEXE Clinic

Division name

Internal Department

Zip code

Address

4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN

TEL

03-5405-1059

Email

info@tes-h.co.jp

Name of contact person

1st name
Middle name
Last name	Toshiyasu Tamura

Organization

TES Holdings Co., Ltd.

Division name

Department of Clinical Trial

Zip code

Address

6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, Japan

TEL

03-6801-8480

Homepage URL

Email

info@tes-h.co.jp

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

Aishitoto Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

08

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

01

Month

24

Day

Date of IRB

Anticipated trial start date

2016

Year

02

Month

15

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

08

Month

16

Day

Last modified on

2016

Year

08

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024086