UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037855 |
|---|---|
| Receipt number | R000043158 |
| Scientific Title | Evaluation of glycation index, beauty index, glucose metabolism and liver function improvement from ingestion of test food. |
| Date of disclosure of the study information | 2019/08/30 |
| Last modified on | 2022/09/20 22:48:13 |
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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
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
matsuo.hv@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 Research Ethics Committee
Address
2-18-6, Higashiueno, Taitou-ku, Tokyo
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043158
