UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052122 |
|---|---|
| Receipt number | R000059486 |
| Scientific Title | A single-arm study on the effect of continuous intake of test food on lowing blood pressure |
| Date of disclosure of the study information | 2025/07/31 |
| Last modified on | 2023/09/05 18:04:42 |
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Basic information
Public title
Study on the effect of continuous intake of test food on lowing blood pressure
Acronym
Study on the effect of test food on lowing blood pressure
Scientific Title
A single-arm study on the effect of continuous intake of test food on lowing blood pressure
Scientific Title:Acronym
Study on the effect of test food on lowing blood pressure
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the effects of test food on lowing blood pressure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of the blood pressure
Key secondary outcomes
Status of capillary
Circulating EV component
Hematological test
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test food: Beverage
Intake period: 12 weeks
Daily intake: 160ml
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects whose systolic blood pressure is between 130mmHg and 139 mmHg.
Key exclusion criteria
Subjects who take a medicine or visit the hospital for disease
Subjects who have taken a medicine for disease within 1month from the start of the study excluding headche,menstrual cramps,cold,etc
Subjects who are currently taking antihypertensive medicatins
Subjects who are current past history of serious illness
Subjects who are treatment for dyslipidemia
Subjects who currently taking supplements and health foods that lower blood pressure
Subjects who are current or past history of the digestive system excluding acute appendicitis
Subjects who donated either 400ml whole blood within 3months,200ml whole blood within 1month,prior to this study
Subjects who have severe anemia
Subjects who have food allegie
Pregnant or lactating women or women who expect to be pregnant during this study
Subjects with disorgered lifestyle during this study
Subjects who are currently participate in other clinical trials, or participated
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasuaki |
| Middle name | |
| Last name | Nakanishi |
Organization
Ezaki Glico Co.Ltd
Division name
Products Development Division Well-being Snack Business unit
Zip code
5558502
Address
4-6-5, Utajima, Nishiyodogawa-ku, Osaka, 555-8502, Japan
TEL
08085191271
yasuaki.nakanishi@glico.com
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Matsumoto |
Organization
Ezaki Glico Co.Ltd
Division name
Products Development Division Well-being Snack Business unit
Zip code
5558502
Address
4-6-5, Utajima, Nishiyodogawa-ku, Osaka, 555-8502, Japan
TEL
09053056676
Homepage URL
tadashi.matsumoto2@glico.com
Sponsor or person
Institute
Ezaki Glico Co.Ltd
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Glico Group
Address
4-6-5, Utajima, Nishiyodogawa-ku, Osaka, 555-8502, Japan
Tel
+81-6-6477-8793
toshihiko.koike@glico.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
| 2025 | Year | 07 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 05 | Day |
Last modified on
| 2023 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059486
