UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041447 |
|---|---|
| Receipt number | R000047302 |
| Scientific Title | A Study for the Effect of a Food Containing Bifidobacterium on Blood Pressure A Randomized, Double-blind, Placebo-controlled, Parallel-group Study |
| Date of disclosure of the study information | 2021/08/16 |
| Last modified on | 2021/06/11 18:12:27 |
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Basic information
Public title
A Study for the Effect of a Food Containing Bifidobacterium on Blood Pressure
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
Acronym
A Study for the Effect of a Food Containing Bifidobacterium on Blood Pressure
Scientific Title
A Study for the Effect of a Food Containing Bifidobacterium on Blood Pressure
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
Scientific Title:Acronym
A Study for the Effect of a Food Containing Bifidobacterium on Blood Pressure
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the effects of Bifidobacterium intake on blood pressure in Japanese male and female
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure
Amount of salt intake
Questionnaire
Key secondary outcomes
SNPs
Safety
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants will intake one active capsule per day for twelve weeks. They will also get clinical tests before and 4, 8, 12 weeks after the beginning of the intervention.
Interventions/Control_2
Participants will intake one placebo capsule per day for twelve weeks. They will also get clinical tests before and 4, 8, 12 weeks after the beginning of the intervention.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects with diastolic blood pressure of 85-89 mmHg or systolic blood pressure of 130-139 mmHg at clinic.
Key exclusion criteria
1. Subjects who have a disease and are receiving continuous pharmaceutical treatment
2. Subjects with prior receipt of any continuous pharmaceutical treatment, aiming to cure a symptom, less than a month before enrolment (excluding medicine for common cold and pollen allergy)
3. Subjects with current alcohol/drug abuse and receiving treatment; or those with previous history of alcohol/drug abuse
4. Subjects with previous and/or current medical history of serious disease (e.g. liver, kidney, heart, lung, blood)
5. Subjects with prevalence of digestive system comorbidities and previous medical history of the system
6. Subjects with serious anemia
7. Subjects with a risk of presenting allergic reaction to test capsule, other food, and medicine
8. Females who are pregnant and/or lactating, or those with willingness/intention to become pregnant during the study
9. Subjects that plan to have irregular life cycle (e.g. midnight shift work, travel) and/or those with extremely irregular dining and sleep habits
10. Subjects with planned or prior (less than 3 months) continuous receipt of any food/functional food/supplement claiming an effect on blood pressure improvement
11. Subjects that cannot restrict themselves from taking yogurt, fermented milk, or food/intestinal medicine/supplement that contain effective microorganisms (e.g. Lactobacillus, Bifidobacterium), or functional food/supplement that effect intestinal environment (e.g. oligosaccharide, dietary fiber)
12. Subjects that cannot maintain their usual amount and frequency of alcohol intake
13. Subjects with current or past (less than 3 months) experience of participating in other clinical studies
14. Subjects with current or past (less than 1 month) history of smoking
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Oi |
Organization
DeNA Life Science, Inc
Division name
Member of the Board
Zip code
150-8510
Address
Shibuya Hikarie. 2-21-1. Shibuya. Shibuya-ku, Tokyo
TEL
0343667219
IRB_dis@dena.com
Public contact
Name of contact person
| 1st name | Shoko |
| Middle name | |
| Last name | Sassa |
Organization
DeNA Life Science, Inc
Division name
MYCODE service Dept
Zip code
150-8510
Address
Shibuya Hikarie. 2-21-1. Shibuya. Shibuya-ku, Tokyo
TEL
0343667219
Homepage URL
IRB_dis@dena.com
Sponsor or person
Institute
DeNA Life Science, Inc
Institute
Department
Personal name
Funding Source
Organization
NISSIN FOODS HOLDINGS CO., LTD.
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
The ethical committee of DeNA Life Science, Inc
Address
Shibuya Hikarie. 2-21-1. Shibuya. Shibuya-ku, Tokyo
Tel
03-4366-7219
IRB_dis@dena.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
| 2021 | Year | 08 | Month | 16 | 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
| 2020 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 20 | 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 | 08 | Month | 17 | Day |
Last modified on
| 2021 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047302
