UMIN-CTR Clinical Trial

Basic information
Public title	Test of re-verification of blood AGEs lowering effect (CML, 3-DG) and evaluation of effectiveness to the skins by intake of test food for 12 weeks
Acronym	Test of re-verification of blood AGEs lowering effect and evaluation of effectiveness to the skins by intake of test food for 12 weeks
Scientific Title	Test of re-verification of blood AGEs lowering effect (CML, 3-DG) and evaluation of effectiveness to the skins by intake of test food for 12 weeks
Scientific Title:Acronym	Test of re-verification of blood AGEs lowering effect and evaluation of effectiveness to the skins by intake of test food for 12 weeks
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate of blood AGEs lowering effect and effectiveness and safety to the skins by continuous intake of test food
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood AGEs(CML, 3-DG, pentosidine, MRX)
Key secondary outcomes	facial image analysis, trans-epidermal water loss(TEWL), horny layer water content, skin viscoelasticity, collect of horny layer (analysis of cell area, multiple peeling, carbonylated protein), questionnaire (changes in skin condition, impression of ingesting test food)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of test food 3 times a day for 12 weeks
Interventions/Control_2	Intake of placebo 3 times a day for 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

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	60 years-old >
Gender	Female
Key inclusion criteria	(1)30 to 60 years old at the time of consent (2)Persons who are concerned about skin quality of face(self-reported) (3)Persons who can voluntarily consent to participate in the study by consent form
Key exclusion criteria	(1)Having or suspected of having osteoporosis (2)Those who visit the hospital with s skin disease (3)Those who were judged to require treatment with liver function, renal function, glucose metabolism (4)Taking foods and supplements including Vitamin E and using cosmetics, quasi-drugs, health foods, foods (ex. indicating to anti-ageing effect, antioxidant effect) regularly (5)Having atopic dermatitis, urticarial, inflammation, eczema, trauma, acne, warts, age spots at the evaluation area (6)Having a experience of receiving aesthetic medicine or plan to receive during the test (7)Those who have received or plan to receive special skin care treatments at the evaluation area within the past 4 weeks (8)Those who have changed or started using health foods, basic cosmetics and sunscreens at the evaluation area within the past 4 weeks (9)Those who have been exposed to UV light beyond their daily lives within the past 4 weeks or who plan to do so during the test period (10)Night-shift and/or day-shift workers (11)Those who are receiving treatment at medical institutions or those who are judged to be in need of treatment (12)Having a history of serious or psychiatric disorders of glucose metabolism, lipid metabolism, liver function, renal function, heart, cardiovascular system, respiratory system, endocrine system, immune system, nervous system (13)Having a history of alcohol and drug addicts (14)Having a risk of developing allergies to cosmetics and foods(especially almonds) (15)Pregnant and nursing woman and those who wish to become pregnant during the test period (16)Taking part in another test and having plan to take part in another test within the past 4 weeks (17)Those who are judged not suitable to participate in this test by physician(or examiner)
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Kawabata
Organization	EZAKI GLICO Co., Ltd
Division name	R&D LABORATORY
Zip code	555-8502
Address	4-6-5, Utajima, NIshiyodogawa-ku, Osaka
TEL	06-6477-8793
Email	hiroshi.kawabata@glico.com

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name Iizuka
Organization	EZAKI GLICO Co., Ltd.
Division name	R&D LABORATORY
Zip code	555-8502
Address	4-6-5, Utajima, NIshiyodogawa-ku, Osaka
TEL	06-6477-8793
Homepage URL
Email	hiroyuki.iizuka@glico.com

Sponsor
Institute	EZAKI GLICO Co., Ltd.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Brain Care Clinic Ethics Review Committee
Address	Isobe Build. 2F, Samon-Cho13, Shinjyuku-ku, Tokyo
Tel	06-6882-1130
Email	ethics_board@drc-web.co.jp

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	2020 Year 10 Month 22 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	44
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	2020 Year 08 Month 21 Day
Date of IRB	2020 Year 08 Month 21 Day
Anticipated trial start date	2020 Year 09 Month 07 Day
Last follow-up date	2020 Year 12 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 21 Day
Last modified on	2021 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048122