UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042014 |
|---|---|
| Receipt number | R000047949 |
| Scientific Title | Verification of the effects of test food on vascular endothelium functionality and gut environment |
| Date of disclosure of the study information | 2021/10/23 |
| Last modified on | 2021/06/24 11:00:25 |
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Basic information
Public title
Verification of the effects of test food on vascular endothelium functionality and gut environment
Acronym
Verification of the effects of test food on vascular endothelium functionality and gut environment
Scientific Title
Verification of the effects of test food on vascular endothelium functionality and gut environment
Scientific Title:Acronym
Verification of the effects of test food on vascular endothelium functionality and gut environment
Region
| Japan |
Condition
Condition
Healthy men / female subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate effective quantity of test food by observing the effect of the test food on vascular endothelium and gut environment after 12 weeks of consumption.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Flow Mediated Dilation (FMD)
Key secondary outcomes
- Blood pressure (Systolic/Diastolic)
- Reactive hyperemia peripheral arterial tonometry (RH-PAT)
- Gut microbiota
- Gut metabolites
- Defecation characteristics (defecation frequency, No, of defecation, quantity, shape, color, incomplete evacuation, abdominal pain, fecal odor)
- QOL Questionnaire
- Laboratory test value
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
- Test food1: dietary capsule with 500 mg test ingredient.
- 5 capsules will be taken with water per time per day for 12 weeks.
Interventions/Control_2
- Test food2: dietary capsule with 100 mg test ingredient.
- 5 capsules will be taken with water per time per day for 12 weeks.
Interventions/Control_3
- Control food: dietary capsule without test ingredient.
- 5 capsules will be taken with water per time per day 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) Males and females aged between 40 to 65 years old.
(2) Subjects whose flow-mediated dilation (FMD) below 7.0%
(3) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria
(1) Subjects who are currently receiving medication.
(2) Subjects who have a plan or who have taken medication which would affects the trial result (drug for intestinal disorder, antihypertensive, laxative or antibiotics) within a month before the trial start.
(3) Subjects who are regularly consuming food for specified health uses (FOSHU), food with function claims, supplement and/or health foods which would affects the trial results for more the 3 times per week.
(4) Subjects who are breast-feeding, pregnant, and are planning pregnancy.
(5) Subjects who have current medical history/anamnesis of severe cardiac, hepatic, renal or digestive diseases.
(6) Subjects who are heavy use of alcohol.
(7) Subjects who have history of smoking. If subject have quit smoking for more than a month prior to trial, the subject could be included.
(8) Subjects with irregular life style and diet.
(9) Subjects who have allergies to food or medication.
(10) Subjects who are currently participating, or who have been participated to other study for medicine or food within the last 4 weeks of the trial, or who possibly participate to other clinical trial after agreement of this study.
(11) Subjects who donated over 200mL blood and/or blood components within a month to the current study.
(12) Males who donated over 400mL blood and/or blood components within the last 3 months to the current study.
(13) Females who donated over 400mL blood and/or blood components within the last 4 months to the current study.
(14) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study.
(15) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study.
(16) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Fukuda |
Organization
Metabologenomics, Inc.
Division name
Headquarters
Zip code
997-0052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
research@metagen.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Planning & Sales Department
Zip code
101-0047
Address
4F Sanwauchikanda Building, 3-3-5 Uchikanda, Chiyoda-ku, Tokyo, Japan
TEL
+81-3-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Daicel Corporation
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 23 | 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
36
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
| 2020 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 05 | Day |
Last modified on
| 2021 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047949
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