UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048377 |
|---|---|
| Receipt number | R000055087 |
| Scientific Title | Study of the preventive effect of ingestion of foods containing natural product-derived ingredients on arteriosclerosis -Placebo-controlled, randomized, double-blind, parallel-group comparative study- |
| Date of disclosure of the study information | 2022/07/15 |
| Last modified on | 2023/06/22 13:56:27 |
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Basic information
Public title
Study of the preventive effect of ingestion of foods containing natural product-derived ingredients on arteriosclerosis
Acronym
Preventive effect of ingestion of test food on arteriosclerosis
Scientific Title
Study of the preventive effect of ingestion of foods containing natural product-derived ingredients on arteriosclerosis -Placebo-controlled, randomized, double-blind, parallel-group comparative study-
Scientific Title:Acronym
Preventive effect of ingestion of test food on arteriosclerosis
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of preventive effects on arteriosclerosis by ingestion of foods containing natural product-derived ingredients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Urinary UrotensinII levels
Fingertip capillary clinical images
Blood pressure and pulse
Key secondary outcomes
Various questionnaires,
Blood oxygen saturation concentration,
Comparison of the results of the previous year's and post-trial checkups,
Optional persistent blood glucose measurement
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
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily ingestion 1 pack of food containing natural product-derived ingredients (EsV3) for 14 weeks.
Interventions/Control_2
Daily ingestion 1 pack of placebo food for 14 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Subjects who have received adequate explanation and understand the purpose and content of this study, volunteered freely, and are able to give their own written informed consent.
(2)Healthy males and females from 20 to 65 years of age
Key exclusion criteria
(1)Subjects with allergies (drugs and test food-related foods)
(2)Females who are pregnant, lactating, or willing to become pregnant during the study period
(3)Subjects being treated for the following diseases
Malignant tumore, renal failure, heart failure, myocardial infarction, cerebral infarction, immunodeficiency, collagen disease
(4)Subjects with pacemakers or implantable cardioverter defibrillators
(5)Smokers (average 21 cigarettes per day or more), regular users of alcohol (average daily net alcohol of 60g or more), or those with extremely irregular lifestyle habits.
(6)Subjects taking prescription drugs that affect the study
(7)Subjects who have participated in other clinical trials for 28 days before the date of informed consent or who are scheduled to participate during the study period.
(8)Subjects who were deemed inappropriate for inclusion in the study by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hisanori/Takashi |
| Middle name | |
| Last name | Tani /Hattori |
Organization
HYDROX Inc.
Division name
Hannou Laboratory
Zip code
357-0045
Address
610-19 Kasanui, Hannou-shi, Saitama, Japan
TEL
042-983-8080
ta2-13@hydrox.co.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Nakata |
Organization
SQL INC.
Division name
CRC
Zip code
164-0013
Address
3-1-15Yayoicho, Nakano-ku,Tokyo,Japan
TEL
090-1706-1329
Homepage URL
nakata@sql-i.com
Sponsor or person
Institute
HYDROX Inc.
Institute
Department
Personal name
Funding Source
Organization
HYDROX Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
NANOHANA CLINIC
SQL INC.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1599
jimukyoku@mail.souken-r.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 15 | 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
65
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
| 2022 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 14 | Day |
Last modified on
| 2023 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055087
