UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025986 |
|---|---|
| Receipt number | 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 17:31:13 |
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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
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
kawaih@arkray.co.jp
Sponsor or person
Institute
TTC CO., LTD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029869
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