UMIN-CTR Clinical Trial

Public title

Effect of the Test Food on Anti-Glycative Actions, Skin Quality and Endothelial Function

Acronym

Effect of the Test Food on Anti-Glycative Actions, Skin Quality and Endothelial Function

Scientific Title

Effect of the Test Food on Anti-Glycative Actions, Skin Quality and Endothelial Function

Scientific Title:Acronym

Effect of the Test Food on Anti-Glycative Actions, Skin Quality and Endothelial Function

Region

Japan

Condition

N/A (healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to evaluate effect of the test food on anti-glycative actions, skin quality and endothelial function.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]Skin quality evaluation (Transepidermal water loss, skin moisture content, skin viscoelasticity, image analysis by VISIA, observation for skin condition by dermatologists), anti-glycation evaluation (Skin AGEs deposition, blood pentosidine), and vascular endothelial evaluation (acceleration pulse wave, arterial pressure-volume index, arterial velocity pulse index).

⁽¹⁾
Week 0, Week 4, Week 8, Week 12 (image analysis of Visia will be held in Week 0 and Week 12).

Key secondary outcomes

*Safety
[1]Blood pressure, pulsation (Week 0, Week 4, Week 8, Week 12)
[2]Weight, body fat percentage, BMI (Week 0, Week 4, Week 8, Week 12)
[3]Blood test (Week 0, Week 4, Week 8, Week 12)
[4]Blood biochemical test (Week 0, Week 4, Week 8, Week 12)
[5]Urine analysis (Week 0, Week 4, Week 8, Week 12)
[6]Doctor's questions (Week 0, Week 4, Week 8, Week 12)

*Other index
[1]Subject's diary (From the first day of ingestion of a test material to the last day of the test)

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

Treatment

Type of intervention

Food

Interventions/Control_1

Oral intake of the test food (1 time in a day, 12 weeks)

Interventions/Control_2

Oral intake of the placebo food (1 time in a day, 12 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

60

years-old

>

Gender

Female

Key inclusion criteria

[1]Females aged 20-59 years.
[2]Individuals who are healthy and have no chronic physical disease including skin disease.
[3]Individuals who are concerning on skin sagging and dullness.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can have an examination in a designated day.
[6]Individuals judged appropriate for the study by the principal.

Key exclusion criteria

[1]Individuals using medical products.
[2]Individuals who used or applied a drug for treatment of disease in the past 1 month.
[3]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[4]Individual who have digestive organ disease.
[5]Individuals whose systolic blood pressure is over 160mmHg or diastolic pressure is over 100mmHg.
[6]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[7]Individuals with serious anemia.
[8]Individuals who are sensitive to test product or other foods, and medical products.
[9]Individuals who are or are possibly pregnant, or are lactating.
[10]Individuals who have an addiction to alcohol or a mental illness.
[11]Individuals who are a smoker.
[12]Individuals whose bowel habit is irregular.
[13]Individuals with possible changes of life style during the test period.
[14]Individuals whose skin is sensitive or who is a chronic red face.
[15]Individuals with skin disease, such as atopic dermatitis.
[16]Individuals with probable seasonal allergy during the test period.
[17]Individuals who are sensitive to cold.
[18]Individuals who are busy to their own work, housework or child care and neglect skin care.
[19]Individuals who cannot avoid daylight exposure during the test period.
[20]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
[21]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[22]Individuals who use cosmetics having a strong moisturizing effect or improving effect for wrinkle.
[23]Individuals who had been conducted an operation on the test spot in the past 6months.
[24]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[25]Individuals judged inappropriate for the study by the principal.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Shuji Nakata

Organization

Medical Corporation Bokushinkai CLINTEXE Clinic

Division name

Head

Zip code

Address

4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN

TEL

+81-3-5405-1059

Email

info@tes-h.co.jp

Name of contact person

1st name
Middle name
Last name	Ryoma Shimizu

Organization

TES Holdings Co., Ltd.

Division name

Administrative Department of Clinical Trials

Zip code

Address

6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN

TEL

+81-3-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

Nippon Shinyaku 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

Date of disclosure of the study information

2018

Year

04

Month

19

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

2015

Year

12

Month

08

Day

Date of IRB

Anticipated trial start date

2016

Year

01

Month

26

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

04

Month

19

Day

Last modified on

2018

Year

04

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036755