UMIN-CTR Clinical Trial

Public title

Evaluation of skin moisturizing effects by a vegetable and fruit juice intake.

Acronym

Evaluation of skin moisturizing effects by a vegetable and fruit juice intake.

Scientific Title

Evaluation of skin moisturizing effects by a vegetable and fruit juice intake.

Scientific Title:Acronym

Evaluation of skin moisturizing effects by a vegetable and fruit juice intake.

Region

Japan

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to evaluate skin moisturizing effects by a vegetable and fruit juice intake.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Stratum corneum water content at 4 and 8 weeks

Key secondary outcomes

Skin elasticity, textures and wrinkles of skin, pigmentation, advanced glycation end products, and skin condition questionnaire at 4 and 8 weeks

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

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of test food for 8 consecutive weeks

Interventions/Control_2

Intake of placebo for 8 consecutive 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

20

years-old

<=

Age-upper limit

59

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Japanese males and females aged 20 to 59 years old when agree to informed consent
2) Persons who have rough skins
3) Persons who have some age spots on face
4) Persons who have sagging skin
5) Persons who keep a stable lifestyle on dietary habit, especially meal time, and sleep
6) Persons who always eat breakfast every morning
7) Persons who are able to fill in all the necessary items on a daily questionnaire with intake diary and approximately 10 queries and another questionnaire about dietary survey of approximately 10 queries at designated days

Key exclusion criteria

1) Persons who are pregnant, could be pregnant in near future, or are lactating.
2) Persons who have menstrual disorder or have a significant change of some skin conditions by menstrual
3) Persons who might have an allergic symptoms on any components of test products.
4) Persons who are participating in other clinical trials
5) Persons who have a habit to take any more than 200ml vegetable juices three times a week
6) Persons who are routinely taking or applying any medicines for whitening and beautiful skin or anti-ultraviolet effect that might affect outcomes of this clinical trial
7) Persons who are routinely taking any health foods for whitening and beautiful skin or anti-ultraviolet effect that might affect outcomes of this clinical trial
8) Persons who have a past medical history of serious hepatopathy, renal problem, and cardiovascular disease
9) Persons who have a history of hepatitis or are affected
10) Persons who dislike vegetable juices, especially carrot one
11) Persons who have any skin damage or diseases such as wound and atopic dermatitis
12) Persons who have conducted a special facial treatment such as esthetic clinic, iontophoresis therapy, and peeling
13) Persons who have a plan to change their cosmetics used during this clinical trial
14) Persons who work night or irregular shifts

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Takashi Koikeda

Organization

Shiba Palace Clinic

Division name

Chair

Zip code

Address

6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan

TEL

81-3-5408-1590

Email

jimukyoku@mail.souken-r.com

Name of contact person

1st name
Middle name
Last name	Azusa Kouno

Organization

SOUKEN Co., Ltd

Division name

Management Division

Zip code

Address

3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan

TEL

81-3-5408-1555

Homepage URL

Email

a_kouno@mail.souken-r.com

Institute

Shiba Palace Clinic

Institute

Department

Personal name

Organization

ITO EN, 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

2018

Year

03

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

There was no significant difference between groups.

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

2017

Year

12

Month

20

Day

Date of IRB

Anticipated trial start date

2018

Year

02

Month

11

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

02

Month

06

Day

Last modified on

2019

Year

03

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035419