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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028510
Receipt No. R000032539
Scientific Title Effects of administrating of test foods for 8 weeks on skin condition in subjects
Date of disclosure of the study information 2017/08/08
Last modified on 2017/08/03

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Basic information
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
Condition Healthy subjects
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute House Wellness Foods Corporation
Research and Development Institute
Institute
Department

Funding Source
Organization House Wellness Foods Corporation
Research and Development Institute
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
Address
Tel
Email

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
2017 Year 08 Month 08 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
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
Other related information

Management information
Registered date
2017 Year 08 Month 03 Day
Last modified on
2017 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032539

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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