UMIN-CTR Clinical Trial

Public title

Study on the accumulation of AGEs by test food intake

Acronym

Study on the accumulation of AGEs by test food intake

Scientific Title

Study on the accumulation of AGEs by test food intake

Scientific Title:Acronym

Study on the accumulation of AGEs by test food intake

Region

Japan

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is accumulation of AGEs by test food intake and verification of safety.
Have a healthy woman aged between 50 and 70 take a test food for 4 weeks. The accumulation of AGEs and safety of it will be verified in a single blind group comparison test with placebo food as a control.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Accumulation of AGEs(Fluorescent AGEs,CML, Pentosidine)

Key secondary outcomes

Safety(Blood biochemistry etc.)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral ingestion of the test product A(4 weeks)

Interventions/Control_2

Oral ingestion of the test product B(4 weeks)

Interventions/Control_3

Oral ingestion of the control product(4 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

50

years-old

<=

Age-upper limit

70

years-old

>

Gender

Female

Key inclusion criteria

[1]Japanese females aged 50-69 years
[2]Healthy individuals not receiving any medical disease treatment
[3]Individuals voluntarily join the study with
written informed consent
[4]Individuals who can have an examination on a designated check day
[5]Individuals judged appropriate to join this study by principal investigators

Key exclusion criteria

[1]Individuals using medical products
[2]Individuals with skin disease,such as atopic dermatitis
[3]Individuals who have an inflammation or a scar on a measuring area
[4]Individuals under treatment or with history of mental disorders, sleep disorders,hypertension,diabetes,lipid metabolism abnormality,or other serious disorders
[5]Individuals receiving/received medical drug treatment for the past 1 month except for temporary relief medication for headache,menstrual pain,common cold,etc.
[6]Individuals with history of serious diseases (hepatic,renal,cardiovascular,respiratory,hematologic,etc.)
[7]Individual who have digestive organ disease
[8]Individuals donated blood >200ml in past 1 month or >400ml in past 3 months
[9]Individual who have experienced mood disorder or physical condition deterioration due to blood sampling in the past
[10] Individuals deemed sensitive to the test product or highly allergic to foods or medical drugs
[11]Currently,health food,supplements with continuous ingestion habits,individuals who intend to intake during the examination period (but not those who can stop taking the intake at the time of consent acquisition)
[12]Individuals with alcohol intake exceeding 60g/day,as ethanol volume
[13]Individuals who may significantly change exercise habit or lifestyle during the study period(ex. travel for a long time)
[14]Pregnant or lactating women (expected,desired inclusive)
[15]Individuals who will get sunburned during the test period
etc.
[16]Individuals participating or planning to join the other clinical investigations during the study period
[17]Individual with potential conflict of interests
[18]Individuals judged inappropriate for the study by the principal

Target sample size

24

Name of lead principal investigator

1st name
Middle name
Last name	Yoshikazu Yonei

Organization

Doshisha University

Division name

Graduate School of Life and Medical Sciences

Zip code

Address

1-3 Tatara Miyakodani Kyotanabe City Kyoto, 610-0394, Japan

TEL

0774-65-6394

Email

yyonei@mail.doshisha.ac.jp

Name of contact person

1st name
Middle name
Last name	Toshiyasu Tamura

Organization

TES Holdings Co., Ltd.

Division name

Department of Clinical Trial

Zip code

Address

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

TEL

03-6801-8480

Homepage URL

Email

info@tes-h.co.jp

Institute

Anti-Aging Bank Co.,Ltd.

Institute

Department

Personal name

Organization

Sunsho Pharmaceutical 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

一般社団法人オリエンタル労働衛生協会東京支部　オリエンタル上野健診センター（東京都）

Date of disclosure of the study information

2018

Year

01

Month

09

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

12

Month

11

Day

Date of IRB

Anticipated trial start date

2018

Year

01

Month

10

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

01

Month

05

Day

Last modified on

2018

Year

08

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034916