UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049792 |
|---|---|
| Receipt number | R000056698 |
| Scientific Title | An open-label, single-arm study to evaluate the efficacy of yogurt containing probiotic bifidobacterium LKM512 and arginine on vascular endothelial function and blood pressure |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2022/12/15 13:24:10 |
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Basic information
Public title
Effects of yogurt containing probiotic bifidobacterium LKM512 and arginine on vascular endothelial function and blood pressure
Acronym
Effects of yogurt containing probiotic bifidobacterium LKM512 and arginine on vascular endothelial function and blood pressure
Scientific Title
An open-label, single-arm study to evaluate the efficacy of yogurt containing probiotic bifidobacterium LKM512 and arginine on vascular endothelial function and blood pressure
Scientific Title:Acronym
An open-label, single-arm study to evaluate the efficacy of yogurt containing probiotic bifidobacterium LKM512 and arginine on vascular endothelial function and blood pressure
Region
| Japan |
Condition
Condition
Individuals with preclinical stage of arteriosclerosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of oral administration of yogurt containing probiotic bifidobacterium LKM512 and arginine on vascular endothelial function in individuals with preclinical stage of arteriosclerosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Flow-mediated dilation (FMD) value
Blood pressure
Key secondary outcomes
BMI
Waist circumference
Hematological test, blood biochemical test
Fecal data (fecal microbiome; metabolites such as polyamines and trimethylamine)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The participants are given a 16-week treatment with 100 g yogurt containing bifidobacterium LKM512 (approximately 1 billion viable bacterial cells) and arginine (600 mg) once a day.
Interventions/Control_2
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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese male and female aged 35 to 64
2. Body-mass index (BMI) 25-30 kg/m2
3. Obtained written informed consent from the volunteers for the study participation
Key exclusion criteria
1. Participants who take a medicine, or visit the hospital for disease
2. Participants who are undergoing diet therapy or exercise therapy under medical supervision
3. Participants with current or past history of serious illness
4. Participants who can't stop taking over-the-counter drugs, quasi-drugs, and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims)
5. Participants who have drug or food allergies
6. Participants who donated component blood or 200 ml of whole blood within 1 month prior to the start of this study
7. Participants who donated 400 ml of whole blood within 4 months prior to the start of this study
8. Participants who have participated or are participating in other clinical study within one month prior to the obtaining consent, or those who plan to participate during the study period
9. Participants who are pregnant or breastfeeding, or those who might become pregnant during the study period
10. Participants who drink a lot of alcohol (60 g/day, the volume of pure alcohol)
11. Participants who have an irregular life rhythm, such as those who have extremely irregular eating habits, those who are shift workers, or those who work the graveyard shift
12. Inappropriate cases evaluated by medical doctors
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Matsumoto |
| Middle name | |
| Last name | Mitsuharu |
Organization
Kyodo Milk Industry Co., Ltd.
Division name
Research Laboratories
Zip code
190-0182
Address
20-1 Hirai, Hinode-machi, Nishitama-gun, Tokyo
TEL
042-597-5911
m-matumoto@meito.co.jp
Public contact
Name of contact person
| 1st name | Takahama |
| Middle name | |
| Last name | Tsuyoshi |
Organization
Seishukai Clinic
Division name
Clinical trial office
Zip code
111-0036
Address
3-18-5 Matsugaya, Taito-ku, Tokyo
TEL
080-4410-9269
Homepage URL
t-takahama@seishukai.or.jp
Sponsor or person
Institute
Kyodo Milk Industry Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kyodo Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The University of Tokyo, Institute of Medical Science, Prof. Toru Suzuki
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seishukai Clinic Institutional Review Board
Address
3-18-5 Matsugaya, Taito-ku, Tokyo
Tel
080-4410-9269
t-takahama@seishukai.or.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
成守会クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 01 | 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
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 01 | 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 | 12 | Month | 15 | Day |
Last modified on
| 2022 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056698
| 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 |
