UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015242 |
|---|---|
| Receipt number | R000017720 |
| Scientific Title | Anti- glycation effect of "AG herb MIX" -containing food intake - A randomized, double blind, placebo-controlled study - |
| Date of disclosure of the study information | 2014/09/24 |
| Last modified on | 2017/02/03 10:36:29 |
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Basic information
Public title
Anti- glycation effect of "AG herb MIX" -containing food intake
- A randomized, double blind, placebo-controlled study -
Acronym
Anti- glycation effect of "AG herb MIX" intake
Scientific Title
Anti- glycation effect of "AG herb MIX" -containing food intake
- A randomized, double blind, placebo-controlled study -
Scientific Title:Acronym
Anti- glycation effect of "AG herb MIX" intake
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-glyaction effect "AG herb MIX" -containing food intake
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Skin elasticity, skin carboxymethylysine, skin AGEs accumulation, carboxymethylysine, 3-deoxyglucosone
Key secondary outcomes
skin color, skin image analysis by VISIA, fasting plasma glucose, HbA1c, insulin, questionnaire( the Anti-Aging QOL Common Questionnaire, skin questionnaire)
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 a capsule including AG herb MIX once a day in fasting for 12 weeks
Interventions/Control_2
Ingestion of a placebo capsule including AG herb MIX once a day in fasting 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
Healthy Japanese women ages 45 or more and less than 65 years old
Key exclusion criteria
1)Diabetics receiving medication or who need treatment
2)Persons with food allergy
3)Patients with a history of serious liver, renal or heart disease
4)Persons with the skin chronic disease including atopic dermatitis
5)Smoking persons
6)Persons with less than five hours in mean sleep
7)Users of anti-glycation foods or cosmetics
8)Users of foods or supplements affecting blood glucose
9)Patients who might affect the test values during the study due to chronic diseases or acute diseases
10)Patients with food or medicine allergies
11)Patients who had surgery of the digestive tract
12) Patients suspected of chronic or acute infectious diseases
13) Persons with high BMI more than 30
14)Persons who participated in other clinical trials within one month before start of this examination
15)Persons who have a difficulty in keeping their habits and customs
16)Persons who have a difficulty keeping a life diary
17)During the pregnancy or persons nursing and persons who may be pregnant
18)Persons who had donated > 200 mL of blood within 1 month or > 400 mL within 3 months prior to the study
19)Persons who work for anti-glycation foods related companies, or persons who have family members working for such companies
20)Persons who may eat or drink too much during this trial , or who have a habit of eating out
21)Persons who have been judged to be inappropriate for the study by a human medical trial supervisor
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiji Ohbayashi |
Organization
Ohbayashi Clinic
Division name
doctor and director
Zip code
Address
4-291 Ryogae-cho, Fushimi-ku, Kyoto, JAPAN
TEL
075-605-1313
keiji-ob@grape.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshige Kawai |
Organization
Karada Lab, Inc.
Division name
no division
Zip code
Address
Yousuien-nai, 59 Gansuin-cho, Kamigyo-ku, Kyoto, JAPAN
TEL
050-5830-0973
Homepage URL
http://ebn.arkray.co.jp/
kawaih@arkray.co.jp
Sponsor or person
Institute
Karada Lab, Inc.
Institute
Department
Personal name
Funding Source
Organization
Karada Lab, 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
Address
Tel
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
医療法人 千里丘協立診療所（大阪府）
エイキット株式会社 生命医科学検査センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.toukastress.jp/webj/month/2016
Number of participants that the trial has enrolled
Results
Blood 3-deoxyglucosone decreased.
Melanin index and color difference b* (yellow) of the upper arm skin, and a brown spots of the face skin were improved.
Blood oxygen saturation index of the cheeks skin increased.
Glycative Stress Research 2016; 3 (4): 236-245
http://www.toukastress.jp/webj/article/2016/GS16-19.pdf
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
| 2014 | Year | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 05 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 24 | Day |
Last modified on
| 2017 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017720
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
