UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041756 |
|---|---|
| Receipt number | R000047629 |
| Scientific Title | Effect of food containing water chestnut peel extract/lutein on changes in fingertip skin-measured advanced glycation endproducts/carotenoid levels |
| Date of disclosure of the study information | 2020/09/28 |
| Last modified on | 2022/03/31 16:56:57 |
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Basic information
Public title
Effect of food containing water chestnut peel extract/lutein on changes in fingertip skin-measured advanced glycation endproducts/carotenoid levels
Acronym
Effect of food containing water chestnut peel extract/lutein on changes in fingertip skin-measured advanced glycation endproducts/carotenoid levels
Scientific Title
Effect of food containing water chestnut peel extract/lutein on changes in fingertip skin-measured advanced glycation endproducts/carotenoid levels
Scientific Title:Acronym
Effect of food containing water chestnut peel extract/lutein on changes in fingertip skin-measured advanced glycation endproducts/carotenoid levels
Region
| Japan |
Condition
Condition
Eye disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of food containing water chestnut peel extract/lutein on changes in fingertip skin-measured advanced glycation endproducts(AGEs)/carotenoid levels
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change value/change rate in fingertip skin-measured AGEs/carotenoid levels 3 months after ingestion of food containing water chestnut peel extract/lutein
Key secondary outcomes
Changes in blood pressure, body weight, corrected visual acuity, and intraocular pressure
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral administration of food containing water chestnut peel extract/lutein(Sante Wellvision), 2 tablets once a day for 3 months
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Outpatient
2)20 years old and over, 75 years old and under
3)Willingness to provide written informed consent
4)Those who have a stable eye disease and are judged by the investigator that there is no need to change the ophthalmic drug or surgery within three months after participating in this study
5)Those who want to take Sante Wellvision
6)BCVA: 0.5 or more for both eyes
7)Intraocular pressure: 20mmHg or less for both eyes (Goldmann applanation tonometer)
8)Vegimeter measurement index value: 352 (Japanese average 95 percent confidence interval upper limit) or less
9)AGEs sensor measurement value: 0.49 (non-diabetic Japanese average 95 percent confidence interval lower limit) or more
Key exclusion criteria
1)severe systemic diseases
2)Those who are more likely to have decreased visual acuity and increased intraocular pressure within 3 months due to progression of eye disease
3)Smoker
4) Those who have a continuous intake habit of supplements that advocate anti-oxidation and anti-glycation over the past 6 months, or are scheduled to take supplements during this study period
5) Those who may change their lifestyle during this study period
6)Pregnant, lactating, or possibly pregnant
7)Those who may have allergic reactions to food containing water chestnut peel extract/lutein, and serious allergic reactions to other foods or drugs
8)Those who are judged to be ineligible for the purpose of this study by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Tanito |
Organization
Shimane university faculty of medicine
Division name
Department of Ophthalmology
Zip code
693-8501
Address
89-1, Enya, Izumo, Shimane, 693-8501, Japan
TEL
0853-20-2284
mtanito@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukari |
| Middle name | |
| Last name | Yamane |
Organization
Shimane university faculty of medicine
Division name
Department of Ophthalmology
Zip code
693-8501
Address
89-1, Enya, Izumo, Shimane, 693-8501, Japan
TEL
0853-20-2284
Homepage URL
yyukari@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane university
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical 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
Shimane University Hospital Clinical Trial Center
Address
89-1, Enya, Izumo, Shimane, 693-8501, Japan
Tel
0853-20-2259
kenkyu@med.shimane-u.ac.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
| 2020 | Year | 09 | Month | 28 | 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
20
Results
Compared to baseline, the AGEs score was significantly lower, and the carotenoids score was significantly higher at 3 months. Routine examinations parameters including blood pressure, body weight, best-corrected visual acuity, and intraocular pressure were equivalent between baseline and 3 months.
Results date posted
| 2022 | Year | 03 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Adverse events recorded included gain of body weight due to the exacerbation of existing kidney disease in one subject, and transient diarrhea after 1 month of the supplementation in one subject; those events were inferred that there was no causal relationship to the supplement.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 11 | Day |
Last modified on
| 2022 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047629
