UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054234 |
|---|---|
| Receipt number | R000061906 |
| Scientific Title | Survey on sense of health by measuring glycative stress markers |
| Date of disclosure of the study information | 2024/04/24 |
| Last modified on | 2024/04/22 16:47:24 |
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Basic information
Public title
Survey on sense of health by measuring glycative stress markers
Acronym
Survey on sense of health by measuring glycative stress markers
Scientific Title
Survey on sense of health by measuring glycative stress markers
Scientific Title:Acronym
Survey on sense of health by measuring glycative stress markers
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The excessive intake of carbohydrates, which is common among modern people, promotes the production of substances called advanced glycation end products (AGEs) in the body, which accelerate aging, and increases the risk of various diseases. Doshisha University Professor Yoshikazu Yonei and his colleagues reported that ingesting ingredients that have the effect of inhibiting AGE production, such as those rich in vegetables, fruits, spices, and herbs, can inhibit AGE production and promote decomposition, helping to maintain a healthy state. The inhibitory effect on AGE production contained in foods can be expressed as the "aminoguanidine (AG) equivalent".
It is expected that consuming "AG equivalent of 500 mg/day or more" can suppress glycative stress and help maintain and improve health conditions. However, there is no data showing that glycative stress can be reduced by consumers having a diet that is conscious of AG equivalent.
In this study, we verified whether labeling AG equivalents on foods and dishes is effective, in the same way as displaying salt equivalent or protein, in improving people's sense of health after providing basic nutrition education to lead a healthy diet. Verification is performed by comparing glycation stress markers before and after. The research results are expected to contribute to extending healthy life expectancy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[1] Measurement of fluorescent AGEs by AGE reader
[2] Anti-Aging QOL Common Questionnaire
[3] Questionnaire survey (Food Intake Frequency and Dietary Practices Questionnaire, Implementation Status Questionnaire)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Continue to eat "AG equivalent conscious meals" at least 4 days a week for 2 months.
Interventions/Control_2
No intervention
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
| 23 | years-old | <= |
Age-upper limit
| 67 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
[1]Healthy men and women between the ages of 23 and 67
[2]Those who are interested in their own health condition.
[3]Those who are able to consume the product four days a week, either in the morning, afternoon, or evening.
Key exclusion criteria
Individuals currently undergoing drug treatment for any disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satomi |
| Middle name | |
| Last name | Akiyama |
Organization
SL Creations Co.,Ltd.
Division name
Health Support Promotion Office
Zip code
144-0043
Address
4-3-1 Haneda, Ota-ku, Tokyo
TEL
03-5735-1611
s_akiyama@sl-creations.co.jp
Public contact
Name of contact person
| 1st name | Satomi |
| Middle name | |
| Last name | Akiyama |
Organization
SL Creations Co.,Ltd.
Division name
Health Support Promotion Office
Zip code
144-0043
Address
4-3-1 Haneda, Ota-ku, Tokyo
TEL
03-6890-1632
Homepage URL
s_akiyama@sl-creations.co.jp
Sponsor or person
Institute
SL Creations Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
SL Creations Co.,Ltd.
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
Society of Glycative Stress Research
Address
6F,Nishishinjuku Mizuma Bldg,3-3-13 Nishishinjuku,Shinjuku-ku,Tokyo
Tel
03-6868-4364
rinri-glycativestress@antiaging-bank.com
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
株式会社SL Creations 健康サポート推進室（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 23 | Day |
Last modified on
| 2024 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061906
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| Registered date | File name |
| Research case data | |
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