UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051176 |
|---|---|
| Receipt number | R000058364 |
| Scientific Title | Preliminary evaluation of the efficacy of plant-derived component on vascular endothelial function |
| Date of disclosure of the study information | 2023/05/26 |
| Last modified on | 2024/05/27 08:08:01 |
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Basic information
Public title
Preliminary evaluation of the efficacy of plant-derived component on vascular endothelial function
Acronym
The effect plant-derived component on vascular endothelial function
Scientific Title
Preliminary evaluation of the efficacy of plant-derived component on vascular endothelial function
Scientific Title:Acronym
The effect plant-derived component on vascular endothelial function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Preliminary evaluation of the efficacy of plant-derived component on vascular endothelial function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Flow Mediated Dilation (FMD) (12 weeks)
Key secondary outcomes
FMD (4, 8 weeks)
Urinary NOx, Urinary 8-OHdG, Urinary 8-isoPGF2a, Serum malondialdehyde (MDA), Serum plant-derived component concentration (4, 8, 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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Placebo beverage (For 12 weeks)
Interventions/Control_2
Beverage containing low-plant-derived components (For 12 weeks)
Interventions/Control_3
Beverage containing high-plant-derived components (For 12 weeks)
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
Male and Female
Key inclusion criteria
1) Healthy adults (ages 40 and over, under age 65, except for premenopausal women)
2) Subjects whose FMD is 4% and over.
3) Subjects who receive a sufficient explanation of the purpose and content of this study, have the ability to fully understand and consent it, and have voluntarily apply for participation with written informed consent.
Key exclusion criteria
1) Subjects who have a chronic disease and are undergoing treatment
2) Subjects with a history or current medical history of serious liver disease, kidney disease, gastrointestinal disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease, or other metabolic disease
3) Subjects diagnosed with arrhythmia at the screening test
4) Subjects who are judged unsuitable for this study based on the screening test
5) Subjects who have a history of gastrointestinal disease or gastrointestinal surgery that affects digestion and absorption
6) Subjects who have allergies to drugs or foods (especially test foods)
7) Subjects who cannot stop taking a supplement or a supplement/healthy food that may affect vascular endothelial function or blood pressure during the study period
8) Subjects who consume foods containing a large amount of the plant-derived component 3 times a week or more
9) Subjects who was collected more than 200 mL of blood within 1 month or 400 mL of blood within 3 months prior to the date of informed consent
10) Subjects who have a history of drug dependence or alcohol dependence
11) Subjects who drink 20 g or more of pure alcohol per day for 3 days or more a week
12) Subjects who smoke 21 or more cigarettes per day on average (including e-cigarettes)
13) Shift worker or late night worker
14) Subjects who are pregnant or who intend to become pregnant during the study period or who are breastfeeding
15) Subjects who are participating in research that takes other foods or medicines, applies cosmetics or medicines or who have participated in other research within one month prior to the date of informed consent or who are willing to participate in other research
16) Subjects who are judged unsuitable for this study by the investigator, principal researcher or researchers
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Takahashi |
Organization
KAGOME CO., LTD.
Division name
Innovation Division
Zip code
329-2762
Address
17, Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
Shingo_Takahashi@kagome.co.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Clinical Trial Management Department
Zip code
105-0023
Address
Shibaura Omodaka Building 7F, 1-9-7, Shibaura Minato-ku Tokyo 105-0023 Japan
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
KSO Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gunma
Tel
027-212-5608
sagawa@mc-connect.co.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
医療法人 前橋北病院(群馬県)（Maebashi North Hospital）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 26 | 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
75
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
| 2023 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 29 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 26 | Day |
Last modified on
| 2024 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058364
