UMIN-CTR Clinical Trial

Public title

Effects of administrating of test foods for 8 weeks on skin condition in subjects

Acronym

Effects of administrating of test foods on skin condition in subjects

Scientific Title

Effects of administrating of test foods for 8 weeks on skin condition in subjects

Scientific Title:Acronym

Effects of administrating of test foods on skin condition in subjects

Region

Japan

Condition

Healthy subjects

Classification by specialty

Dermatology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effects of 8 weeks intake of foods containing turmeric extract or turmeric extract + curcumin on skin condition of the face at the steady state, and skin condition of the back after ultraviolet irradiation

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

water content of the stratum corneum(face)
transepidermal water loss(face)
minimal erythema dose of ultraviolet irradiated area(back)
at 0,4,and 8-week ingestion period

Key secondary outcomes

color difference(face)
elasticity(face)
water content of the stratum corneum of ultraviolet irradiated area(back)
transepidermal water loss of ultraviolet irradiated area(back)
questionnaire(Subjective symptoms of skin condition)
questionnaire(Subjective symptoms of body condition)
questionnaire(Subjective symptoms of mood condition)
at 0,4,and 8-week ingestion period

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of placebo foods(once a day for 8 weeks)

Interventions/Control_2

Intake of foods containing turmeric extract(once a day for 8 weeks)

Interventions/Control_3

Intake of foods containing turmeric extract and curcumin (once a day for 8 weeks)

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

60

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Healthy male and female aged 20 to 60 years old
2)Those whose skin photo type corresponds to Type II or III of Fitzpatrick
3)Those who have erythema on the back skin after UV irradiation
4)Those who show written consent from participating in trial
5)Those who can visit the institution in scheduled date
6)Those who agreed in writing after fully understanding the purpose and contents of this trial

Key exclusion criteria

Those who
1)have been diagnosed with photosensitivity
2)taking drugs that affect the light sensitivity of the skin
3)taking drugs, quasi-drugs, health foods, supplements that emphasizes or promotes efficacy related to the effectiveness examined in this study or joint pain improvement
4)were judged to have a skin disease of the evaluation site by the doctor
5)are using drugs or quasi-drugs that may affect the results of the trial
6)already regularly use cosmetics, foods or supplements that may affect the results of the trial
7)drinks much alcohol, or are heavy smokers
8)have risk of allergies to drugs and foods
9)are hospitalized in dermatology department
10)have factors that may affect the results of the trial on the evaluation site
11)have subjective symptoms of advanced anemia
12)receiving medical treatment at a medical institution for treatment or prevention of diseases, or judged to be in a condition requiring treatment
13)have past or current medical history
14)have received skin care treatment or massage for the evaluation site within the past 4 weeks or are scheduled to receive during the trial period
15)have been exposed to UV beyond daily living such as long-term work outdoors, exercise, sea bathing, tanning salon, etc. during the past 2 months, or planned during the trial period
16)have irregular or disturbed life rhythms such as night shifts and shift work
17)are participating in other trial, have participated in the past 4 weeks or plan to participate in other trial during scheduled period in this trial.
18)are difficult to maintain lifestyle during the trial period
19)are lactating at the time of consent acquisition, pregnant or may be pregnant, or wish to be pregnant during the trial period
20)are difficult to menstruation
21)are difficult to fill in the subject diary
22)are judged inappropriate for participating in the trial by the doctor or investigator of this trial

Target sample size

45

Name of lead principal investigator

1st name
Middle name
Last name	Yoshihiro Yamamoto

Organization

House Wellness Foods Corporation

Division name

Research and Development Institute

Zip code

Address

Imoji 3-20, Itami, Hyogo

TEL

072-778-1121

Email

Yamamoto_Yoshihiro@house-wf.co.jp

Name of contact person

1st name
Middle name
Last name	Tatsuya Ohara

Organization

House Wellness Foods Corporation

Division name

Research and Development Institute

Zip code

Address

Imoji 3-20, Itami, Hyogo

TEL

072-778-1127

Homepage URL

Email

Ohara_Tatsuya@house-wf.co.jp

Institute

House Wellness Foods Corporation
Research and Development Institute

Institute

Department

Personal name

Organization

House Wellness Foods Corporation
Research and Development Institute

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

2017

Year

08

Month

08

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

2017

Year

01

Month

27

Day

Date of IRB

Anticipated trial start date

2017

Year

01

Month

31

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

03

Day

Last modified on

2017

Year

08

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032539