UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of glycation index, beauty index, glucose metabolism and liver function improvement from ingestion of test food.
Acronym	Evaluation of glycation index, beauty index, glucose metabolism and liver function improvement from ingestion of test food.
Scientific Title	Evaluation of glycation index, beauty index, glucose metabolism and liver function improvement from ingestion of test food.
Scientific Title:Acronym	Evaluation of glycation index, beauty index, glucose metabolism and liver function improvement from ingestion of test food.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the anti-glycation effect, beauty effect, glucose metabolism from ingestion of test food.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluate skin AGEs accumulation, internal body AGEs, skin wrinkles, HOMA-IR, AST and ALT when taking the study food continuously for 12 weeks.
Key secondary outcomes	Evaluate other cosmetic indicators, glucose metabolism and liver function items when the study food is continually consumed for 12 weeks.

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	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of capsules including mixed plant extract once a day for 12 weeks.
Interventions/Control_2	Ingestion of capsules not including mixed plant extract once 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	40 years-old <=
Age-upper limit	65 years-old >
Gender	Female
Key inclusion criteria	(1) Female ages 40 or more and less than 65 years old (2) Subjects with a lot of skin AGEs accumulation
Key exclusion criteria	(1)smoking subjects (2)subjects who have a habit of drinking more than 4 times a week (3)less than five hours in mean sleep (4)routinely taking foods or medicines which may affect skin or blood glucose (5)BMI more than 30 (6)treatment or a history of serious disease or affecting a secretion of sex hormones (7)diseases which affect this study (8)expected to be developed the allergy symptoms on skin (9)donated > 200 mL of blood within 1 month or > 400 mL within 3 months prior to the study (10)eat or drink too much during this trial, or who have a habit of eating out (11)treated cosmetic care (12)treated cosmetic care except for measuring sites, or hormonal therapy for one year (13)a facial, a wash-rag, lost hair on measuring sites for one month ago, or plans these actions (14)no habit of preventing sunburn (15)plan to have ultraviolet exposure within a month before the screening test (16)wash the body providing strong skin irritation (17)the skin chronic disease including atopic dermatitis (18)subjects who have the wound or inflammatory disease affecting the measuring skin (19)trouble by rough skin around a menstruates (20)subjects who work for anti-glycation foods related companies, or subjects who have family members working for such companies (21)employed on a pre-dawn shift or on night duty more than 2 times (22)planned to go overseas (23)possibilities for emerging allergy related to the study (24)judged as unsuitable for the study based on the results of clinical and physical examination on screening test (25)participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (26)planned to become pregnant after informed consent for the current study or are pregnant or lactating (27)judged as unsuitable for the study based on the results of lifestyle questionnaire (28)judged as unsuitable for the study by the investigator for other reasons
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Sumio Middle name Last name Kondo
Organization	Medical Corporation Kensho-kai, Fukushima Healthcare Center
Division name	Internal Medicine, Department of Neurosurgery
Zip code	553-0004
Address	2-12-16, Tamagawa, Fukushima-ku, Osaka-shi, Osaka
TEL	06-6441-6848
Email	ko293434@ares.eonet.ne.jp

Public contact
Name of contact person	1st name Naoki Middle name Last name Matsuo
Organization	Karada Lab, Inc.
Division name	No division
Zip code	602-0008
Address	Yousuien-nai, 59 Gansuin-cho, Kamigyo-ku, Kyoto, JAPAN
TEL	070-2440-3772
Homepage URL
Email	matsuo.hv@arkray.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	ARKRAY, Inc.
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	Aisei Hospital Ueno Clinic Research Ethics Committee
Address	2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel	03-6455-0880
Email	t.saito@ttc-smo.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	2019 Year 08 Month 30 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	2019 Year 07 Month 25 Day
Date of IRB	2019 Year 07 Month 25 Day
Anticipated trial start date	2019 Year 09 Month 04 Day
Last follow-up date	2019 Year 12 Month 18 Day
Date of closure to data entry	2020 Year 01 Month 17 Day
Date trial data considered complete	2020 Year 01 Month 24 Day
Date analysis concluded	2020 Year 02 Month 25 Day

Other
Other related information

Management information
Registered date	2019 Year 08 Month 30 Day
Last modified on	2022 Year 09 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043158