UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047853 |
|---|---|
| Receipt number | R000054550 |
| Scientific Title | Effect of Daily Ingestion of the Bifidobacterium and Dietary Fiber on Improving Vascular Endothelial Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study |
| Date of disclosure of the study information | 2022/05/26 |
| Last modified on | 2023/11/28 18:15:21 |
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Basic information
Public title
Effect of Daily Ingestion of the Bifidobacterium and Dietary Fiber on Improving Vascular Endothelial Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
Acronym
Beneficial Effect of the Bifidobacterium and Dietary Fiber on Improving Vascular Endothelial Function.
Scientific Title
Effect of Daily Ingestion of the Bifidobacterium and Dietary Fiber on Improving Vascular Endothelial Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
Scientific Title:Acronym
Beneficial Effect of the Bifidobacterium and Dietary Fiber on Improving 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
To prove improving vascular endothelial function and safety associated with 12 weeks daily ingestion of bifidobacterium and dietary fiber, in a double-blind, placebo-controlled, parallel group comparison study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Flow-mediated dilation after 12 weeks of ingestion.
Key secondary outcomes
Flow-mediated dilation after 8 weeks of ingestion, intestinal flora, adiponectin, PAI-1, hsCRP, GLP-1, serum glucose level, TMAO, PTX3, blood inflammatory marker, heart rate variability, electroencephalogram during sleeping, sleeping record, survey on subjects' sleeping and mental and physical conditions.
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily ingestion 100 g of the drink containing Bifidobacterium and dietary fiber for 12 weeks.
Interventions/Control_2
Daily ingestion 100 g of the drink not containing Bifidobacterium and dietary fiber 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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects who agree to participate in this study with a written informed consent.
2. Subjects whose PTX3 is relatively high.
3. Subjects whose L/H is relatively high.
Key exclusion criteria
1. Subjects with difficulty measuring flow- mediated dilation.
2. Subjects who are under physician's advice, treatment, and/or medication for hypertension, dyslipidemia and/or diabetes.
3. Subjects who have a history of bronchial disease (ex. asthma, tuberculosis, pleurisy).
4. Subjects with implantable electronic medical devices.
5. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
6. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
7. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data.
8. Subjects with severe anemia.
9. Pre- or post-menopausal women complaining of obvious physical changes.
10. Subjects who are at risk of having allergic reactions to drugs or foods especially based on milk.
11. Subjects who used antibiotics within 12 wks, prior to this study.
12. Subjects who regularly use gastrointestinal drugs.
13. Subjects who cannot abstain from taking yoghurt, lactic acid bacteria drink, functional foods which would affect bowl movement during this study.
14. Smokers, alcohol addicts or subjects with disordered lifestyle.
15. Subjects who donated either 400 ml whole blood within 16 wks (women), 12 wks (men), 200 ml whole blood within 4 wks, or blood components within 2 wks, prior to this study.
16. Pregnant or lactating women or women who expect to be pregnant during this study.
17. Subjects who currently participate in other clinical trials, or participated within the last 4 wks prior to this study.
18. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
hisc-acad.res@s.do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
hisc-acad.res@s.do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
National Agriculture and Food Research Organization
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Ezaki Glico Co., Ltd.
IRB Contact (For public release)
Organization
The ethics committee of Hokkaido Information University
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel
011-385-4411
soumu@do-johodai.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
北海道情報大学 保健センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/bbb/advance-article/doi/10.1093/bbb/zbad148/7320324
Number of participants that the trial has enrolled
60
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
Main results already published
Date of protocol fixation
| 2022 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 06 | 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 | 05 | Month | 25 | Day |
Last modified on
| 2023 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054550
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| Registered date | File name |
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