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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025986
Receipt No. R000029869
Scientific Title Evaluation of indicators of glycative stress and beauty for skin from ingestion of test food
Date of disclosure of the study information 2017/02/06
Last modified on 2019/04/23

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Basic information
Public title Evaluation of indicators of glycative stress and beauty for skin from ingestion of test food
Acronym Anti-glycation and beauty effect for skin from ingestion of test food
Scientific Title Evaluation of indicators of glycative stress and beauty for skin from ingestion of test food
Scientific Title:Acronym Anti-glycation and beauty effect for skin from ingestion of test food
Region
Japan

Condition
Condition middle-aged female
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the anti-glycation effect and beauty effect for skin from ingestion of test food
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Skin AGEs accumulation, internal body AGEs, skin carboxymethyl lysine, carboxymethyl lysine, 3-deoxyglucosone, skin elasticity, skin color, skin image analysis by VISIA
Key secondary outcomes Lipid metabolism, sugar metabolism, the Anti-Aging QOL Common Questionnaire, physical measurement, blood pressure

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of capsules including high dose mixed plant extract once a day for 12 weeks
Interventions/Control_2 Ingestion of a capsule including low dose 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) Persons with a lot of skin AGEs accumulation
Key exclusion criteria (1)smoking
(2)less than five hours in mean sleep
(3)routinely taking foods or medicines which may affect skin or blood glucose
(4)BMI more than 30
(5)treatment or a history of serious disease or affecting a secretion of sex hormones
(6)diseases which affect this study
(7)expected to be developed the allergy symptoms on skin
(8)donated > 200 mL of blood within 1 month or > 400 mL within 3 months prior to the study
(9)eat or drink too much during this trial, or habit of eating out
(10)treated cosmetic care on measured site
(11)treated cosmetic care except for measuring sites, or hormonal therapy for one year
(12)a facial, a wash-rag, lost hair on measuring sites for one month ago, or plans these actions
(13)no habit of preventing sunburn
(14)plan to have ultraviolet exposure within a month before the screening test
(15)wash the body providing strong skin irritation
(16)the skin chronic disease including atopic dermatitis
(17)the wound or inflammatory disease affecting the measuring skin
(18)trouble by rough skin around a menstruates
(19)work for anti-glycation foods related companies, or persons who have family members working for such companies
(20)employed on a pre-dawn shift or on night duty more than twice
(21)planned to go overseas
(22)possibilities for emerging allergy related to the study
(23)judged as unsuitable for the study based on the results of clinical and physical examination on screening test
(24)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
(25)planned to become pregnant after informed consent for the current study or are pregnant or lactating
(26)judged as unsuitable for the study based on the results of lifestyle questionnaire
(27)judged as unsuitable for the study by the investigator for other reasons
Target sample size 20

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, 553-0004
TEL 06-6441-6848
Email ko293434@ares.eonet.ne.jp

Public contact
Name of contact person
1st name Hiroshige
Middle name
Last name Kawai
Organization Karada Lab, Inc.
Division name no division
Zip code 602-0008
Address Yousuien-nai, 59 Gansuin-cho, Kamigyo-ku, Kyoto, JAPAN
TEL 050-5830-0973
Homepage URL
Email kawaih@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 IRB
Address 2-18-6 higashiueno, taito-ku, Tokyo, Japan
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 DRC株式会社(大阪府)
いきいきクリニック(大阪府)

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 06 Day

Related information
URL releasing protocol Not opened
Publication of results Partially published

Result
URL related to results and publications No URL
Number of participants that the trial has enrolled 24
Results
Plasma pentosidine and fasting blood glucose were significantly reduced in both groups between before and after 12 weeks of intake. Also, VISIA wrinkles (left and right) were significantly reduced in L group and HOMA-IR was significantly reduced in H group. And, plasma 3-deoxyglucosone was reduced in the L group, and plasma carboxymethyl lysine was reduced in the H group, in trend. In addition, significant decrease was recognized in 5 items of liver function.
Results date posted
2019 Year 04 Month 23 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2018 Year 05 Month 25 Day
Baseline Characteristics
Item (unit) Whole L-group H-group p value
subjects     24     12      12     ---
Age (years) 47.3   48.8    45.9   0.342
Height (cm) 156.7  156.8   156.7  0.936
Weight (kg)  52.3   51.6    52.9  0.726
BMI(kg/m2)   21.2   21.0    21.5  0.662
Participant flow
The analysis number was 11 for both L and H groups.The two subjects were excluded from the efficacy analysis subjects because they suffered from a disease that violated the exclusion criteria after incorporation.
Adverse events
There were no adverse events or abnormal changes in clinical test values, attributable to the test food.
Outcome measures
Plasma pentosidine, fasting blood glucose, VISIA wrinkles (left and right), HOMA-IR, plasma 3-deoxyglucosone, carboxymethyl lysine, 5 items of liver function
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 01 Month 12 Day
Date of IRB
2017 Year 01 Month 12 Day
Anticipated trial start date
2017 Year 02 Month 07 Day
Last follow-up date
2017 Year 05 Month 23 Day
Date of closure to data entry
2017 Year 06 Month 22 Day
Date trial data considered complete
2017 Year 07 Month 04 Day
Date analysis concluded
2017 Year 09 Month 25 Day

Other
Other related information

Management information
Registered date
2017 Year 02 Month 03 Day
Last modified on
2019 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029869

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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