UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049050 |
|---|---|
| Receipt number | R000055841 |
| Scientific Title | Examination of the effect of test food intake on improving vascular function in healthy adults-Randomized, double-blind, placebo-controlled, parallel-group study- |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2024/04/01 15:07:37 |
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Basic information
Public title
Examination of the effect of test food intake on improving vascular function in healthy adults-Randomized, double-blind, placebo-controlled, parallel-group study-
Acronym
Examination of the effect of test food intake on improving vascular function
Scientific Title
Examination of the effect of test food intake on improving vascular function in healthy adults-Randomized, double-blind, placebo-controlled, parallel-group study-
Scientific Title:Acronym
Examination of the effect of test food intake on improving vascular function
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of test food intake on improving vascular function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vascular function
Key secondary outcomes
Subjective feelings evaluation
Blood pressure
Blood analysis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intakes of test food for 12 weeks
Interventions/Control_2
Intakes of placebo food 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
| 45 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Men and women in good health who are between 45 and 70 years old: Women are limited to postmenopausal (Duration of amenorrhea; >1 y)
(2) Subjects whose FMD values of 5.5% >=
(3) Subjects whose baPWV values of 1400 cm/sec <=
(4) Subjects who have a briefing of the content of the present study, fully understanding and agreeing to its objective and are able to provide a written informed consent.
Key exclusion criteria
(1) Subjects who have been diagnosed with heart disease, liver disease, kidney disease, respiratory disease, endocrine disease, metabolic disease, or a history of these diseases
(2) Subjects who have the disease under treatment
(3) Subjects who regularly use supplements, health food (including foods for specified health use / foods with functional claims) during the test period
(4) Subjects who have currently been taking medicines, supplements / health foods or cosmetics with any functional claims such as L-citrulline, L-arginine, L-ornithine, procyanidins, bonito elastin, linolenic acid, DHA, EPA, CoQ10, nattokinase, lutein, blueberries, cassis, vitamin E, ginkgo biloba extract, melilot, polyphenols (hesperidin, flavangenol, pycnogenol etc.)
(5) Subjects who have currently been taking medicines, supplements / health foods or cosmetics for the purpose of improving blood flow and blood pressure in addition to the ingredients listed in (4)
(6) Subjects who take part in another clinical study during the study, or who have participated as subjects in another clinical trials within the past 3 months
(7) Subjects who are excessively take alcohol (expressed in an amount of alcohol: over 20g/day)
(8) Subjects who have a smoking habit (those who smoke daily or occasionally in the last 3 months)
(9) Subjects who conduct hormone replacement therapy in the 3 months.
(10) Asthma patients
(11) Subjects who have severe anemia
(12) Subjects who have multiple irregularities in their lives during the research period due to day / night shift work or night work, or those who are engaged in physical labor such as transporting heavy objects.
(13) Subjects who have been pregnant , or have a plan to breast feed during the study period
(14) Subjects who are judged by the investigator to be inappropriate as subjects based on the test results at the time of screening
(15) Subjects deemed unsuitable by the investigator for other reasons
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Morita |
Organization
Kirin Holdings Company, Limited
Division name
Health Science Research Institute, Health Science Division.
Zip code
251-8555
Address
Shonan Health Innovation Park, 2-26-1, Muraoka-Higashi, Fujisawa, Kanagawa, Japan
TEL
090-3063-2127
Masahiko_Morita@kirin.co.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Tomaru |
Organization
Synapse Planning Company, Limited.
Division name
Clinical Trial Session
Zip code
162-0054
Address
7-5, Kawadacho, Shinjuku-ku, Tokyo, Japan
TEL
03-5604-9442
Homepage URL
tomaru@synaps.co.jp
Sponsor or person
Institute
Kirin Holdings Company, Limited
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company, Limited
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
Research Ethical Review Committee of Kirin Holdings Company, Ltd.
Address
Nakano Central Park South, 4-10-2, Nakano, Nakano-ku, Tokyo, Japan
Tel
03-6837-4128
02976_Ni@kirin.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
東京シーサイドクリニック（東京都）Tokyo seaside clinic (Tokyo)、医療法人社団曙光会 コンフォガーデンクリニック（東京都）, Medical corporation association Shokoukai Comfo-Garden Clinic (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2022 | Year | 09 | Month | 28 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055841
| 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 |
