UMIN-CTR Clinical Trial

Public title

Study on improvement of skin quality with almond chocolate intake

Acronym

Study on improvement of skin quality with almond chocolate intake

Scientific Title

Study on improvement of skin quality with almond chocolate intake

Scientific Title:Acronym

Study on improvement of skin quality with almond chocolate intake

Region

Japan

Condition

healthy volunteer

Classification by specialty

Dermatology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Study on skin quality improvement effect when almond chocolate is continuously ingested for 8 weeks

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1) defecation, flights, flights quantity, bowel movement days
2) stratum corneum turnover
3) serum inflammatory markers (TARC) 4) by dermatologist skin drying condition rating
5) stratum corneum moisture volume 6) percutaneous skin moisture transpiration rate amount
7) skin image analysis (age spots, wrinkles, texture, quantitative evaluation of pores, UV spots, Porphyrin, Brown freckles (melanin), red (hemoglobin))
8) awareness survey (investigation of subjective symptoms of intestinal and skin)

Key secondary outcomes

1) skin enlarged image
2) Lipids in the stratum corneum (horny cell covalently bonded ceramide)
3) Blood spoilage product
4) Eye buttock ski score evaluation

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Test food intake group (8 grains a day for 8weeks)

Interventions/Control_2

Test food non-intake group (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

25

years-old

<=

Age-upper limit

49

years-old

>=

Gender

Female

Key inclusion criteria

1) Those who received a sufficient explanation of the purpose and contents of this exam, who have the capacity to consent, voluntarily volunteer with full understanding, and who agreed to participate in the document
2) Women who are 25 years old or older and under 50 years old who have a defecation frequency of 2 to 4 times per week for the most recent 2 weeks at the time of screening
3) Person who has conscious of drying of skin at screening

Key exclusion criteria

1) Currently, those who have some sort of chronic illness and are undergoing drug treatment
2) Persons who have severe hay fever symptoms
3) Persons who have significant abnormalities in the skin condition of the test site
4) Persons who are allergic to cocoa, almonds, milk, wheat, eggs, soybeans
5) Persons who regularly consume cacao products, nuts on a daily basis
6) Those who ingested or ingested medicines, quasi-drugs, supplements, health foods, foods for specified health use, functional display foods that are likely to affect this test in the course of three months before screening , Those who are scheduled to take or intake during the exam
7) Persons conducting special facial care (Facial Equipment, Aesthetic, Peeling, Laser Therapy etc.)
8) Participants in other clinical and monitoring studies during the first month before screening
9) Persons who are pregnant, plan for pregnancy during the examination period, those whohave hope
10) Breast feeding
11) Others who judged that the investigatoror the test sharing doctor is inappropriateas the subject

Target sample size

70

Name of lead principal investigator

1st name
Middle name
Last name	Maiko Tajima

Organization

Beauty & Health Research_Inc

Division name

Medical Research Department

Zip code

Address

Sankyo Nisisinnjuku Buiding 4F 4-2-18 Nisisinnjuku Shinjuku-ku Tokyo, 160-0023 Japan

TEL

03-5354-7388

Email

info@b-hr.jp

Name of contact person

1st name
Middle name
Last name	Ai Marume

Organization

Beauty & Health Research_Inc

Division name

Medical Research Department

Zip code

Address

Sankyo Nisisinnjuku Buiding 4F 4-2-18 Nisisinnjuku Shinjuku-ku Tokyo, 160-0023 Japan

TEL

03-5354-7388

Homepage URL

Email

marume@b-hr.jp

Institute

Beauty & Health Research Inc

Institute

Department

Personal name

Organization

Meiji 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

株式会社ビューティアンドヘルスリサーチ（東京都）

Date of disclosure of the study information

2017

Year

02

Month

02

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

12

Month

21

Day

Date of IRB

Anticipated trial start date

2017

Year

02

Month

05

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

02

Month

02

Day

Last modified on

2017

Year

07

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029763