UMIN-CTR Clinical Trial

Public title

The effects on skin elasticity and hormone levels of blood by long-term ingestion of test food in human: a double-blind, randomized placebo-controlled, parallel comparison study

Acronym

The effects on skin elasticity and hormone levels of blood by long-term ingestion of test food in human

Scientific Title

The effects on skin elasticity and hormone levels of blood by long-term ingestion of test food in human: a double-blind, randomized placebo-controlled, parallel comparison study

Scientific Title:Acronym

The effects on skin elasticity and hormone levels of blood by long-term ingestion of test food in human

Region

Japan

Condition

Healthy volunteers

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effects of test food on skin elasticity and blood level of hormones

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Skin elasticity

Key secondary outcomes

Blood level of hormones
Skin condition
Safety evaluation

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

Ingestion of test food for 8 weeks

Interventions/Control_2

Ingestion of placebo for 8 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

50

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Subjects aged from 30 to 49 years old at the time informed consent is provided.
2) Subjects who show relatively low levels of blood polypeptides.
3) Subjects who show relatively low skin moisture and skin elasticity.
4) Subjects whose BMI is less than 25.
5) Subjects who can visit to the administrative facility on every inspection day.
6) Subjects who provide the written informed consent for the involvement of this trial by themselves.

Key exclusion criteria

1) Subjects who continuously take a functional food or a supplement.
2) Subjects who continuously take a functional food or quasi-medicine which has same or similar effect with active ingredient of test food.
3) Subjects who frequently intake food which is rich in same active ingredient of test food, or who intake these kind of food during 3 days before and after trial initiation and the last 3 days from the end of trial.
4) Subjects who work on the night shift or the day and night shift.
5) Subjects who are receiving the medical treatment or the prophylactic treatment, or who are diagnosed the need of medical treatment.
6) Subjects who have skin disease or abnormality in skin condition such as atopic dermatitis.
7) Subjects who show the apparent change of skin condition which is not related to the intake of test food at the end of trial compared with the initiation.
8) Subjects who have a past history for the severe disease or abnormality in glucose metabolism, lipid metabolism, liver function, kidney function, cardiovascular system including heart function, respiratory tract, endocrine system and nerve system, or for psychiatric disorder.
9) Subjects who suffer from anemia, or felt sick due to blood collection.
10) Subjects who have a past history of alcoholism or drug addiction.
11) Subjects who have a risk for food allergy.
12) Subjects who show apparent abnormality in blood test, or who are positive for HBs antigen or HCV antibody in trial duration including the screening period.
13) Subjects who are pregnant or during lactation when the informed consent is provided, or who hope to become pregnant during the trial.
14) Subjects who were involved in another trial within 4 weeks prior to this trial, who will participate in another trial.
15) Subjects who are judged to be inappropriate for this trial by the doctor who is responsible for this trial.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Dr. Sumio Kondo

Organization

Medical Corpoation Kenshokai Fukushima Healthcare Center

Division name

Medical Corpoation Kenshokai Fukushima Healthcare Center

Zip code

Address

2-12-13, Tamagawa, Fukushima-ku, Osaka, Japan

TEL

81-(0)6-6882-1130

Email

s.kondo@drc-web.co.jp

Name of contact person

1st name
Middle name
Last name	Yuri Okano

Organization

CIEL Corporation

Division name

CIEL Corporation

Zip code

Address

Renafine 302, 2-10-11, Midori, Sumida-ku, Tokyo

TEL

03-6659-2767

Homepage URL

Email

yuri.okano@ciel-tokyo.com

Institute

DRC Corporation, Ltd.
Product Testing Department

No.9 Tabuchi Bldg. 3F, 2-10-31, Higashi-Temma, Kita-ku, Osaka
Tel: 81-(0)6-6882-1130

Institute

Department

Personal name

Organization

FUJIFILM Corporation

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

2019

Year

03

Month

30

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.mdpi.com/1660-3397/16/12/482/htm

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

2017

Year

08

Month

18

Day

Date of IRB

Anticipated trial start date

2017

Year

09

Month

25

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

08

Month

31

Day

Last modified on

2019

Year

03

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033099