UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052102 |
|---|---|
| Receipt number | R000059460 |
| Scientific Title | The effects of peptide on lowering blood pressure: a randomized, double blind, placebo-controlled study. |
| Date of disclosure of the study information | 2023/09/04 |
| Last modified on | 2024/03/05 09:14:02 |
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Basic information
Public title
The effects of peptide on lowering blood pressure: a randomized, double blind, placebo-controlled study.
Acronym
The effects of peptide on lowering blood pressure: a randomized, double blind, placebo-controlled study.
Scientific Title
The effects of peptide on lowering blood pressure: a randomized, double blind, placebo-controlled study.
Scientific Title:Acronym
The effects of peptide on lowering blood pressure: a randomized, double blind, placebo-controlled study.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of peptide on lowering blood pressure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Systolic blood pressure and diastolic blood pressure
Key secondary outcomes
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
Ingestion of peptide for 12 weeks
Interventions/Control_2
Ingestion of placebo 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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Subjects aged 20-74 years
2)Subjects with systolic blood pressure less than 140 mmHg and diastolic blood pressure less than 90 mmHg
3)Subjects with systolic blood pressure more than 120 mmHg or diastolic blood pressure more than 80 mmHg
Key exclusion criteria
1) Subjects who are undergoing continuous medical treatment.
2) Subjects who regularly use food for specified health uses, functional foods, health foods whose affects this study.
3) Subjects who smoke 20 cigarettes or more per day.
4) Subjects drink alcohol polydipsia (pure alcohol equivalent more than 60 g/day)
5) Subjects whose BMIs are >=30 kg/m^2.
6) Subjects who are under treatment or have a history of disorders such as the heart, liver, kidney, digestive organs, etc.
7) Subjects who have serious allergies to medicines and foods
8) Subjects who are pregnant, planning to become pregnant, or lactating.
9) Subjects who participated in clinical trials of other drugs or foods within one month, or who plan to do just after giving informed consent.
10) Subjects who are judged inappropriate to this trial by the principal investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Nakamura |
| Middle name | |
| Last name | Masahiko |
Organization
Matsumoto City Hospital
Division name
Hospital Director
Zip code
390-1401
Address
4417-180 Hata, Matsumoto, Nagano, Japan
TEL
0263-92-3027
hospi@city.matsumoto.lg.jp
Public contact
Name of contact person
| 1st name | Furuhata |
| Middle name | |
| Last name | Katsuya |
Organization
Matsumoto Health Lab
Division name
None
Zip code
390-0811
Address
M wing 1F, 1-18-1, Chuo, Matsumoto, Nagano, Japan
TEL
0263-39-1139
Homepage URL
info@m-health-lab.jp
Sponsor or person
Institute
Matsumoto City Hospital
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
Research Ethics Committee of Matsumoto City Hospital
Address
4417-180 Hata, Matsumoto, Nagano, Japan
Tel
0263-92-3027
hospi@city.matsumoto.lg.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
| 2023 | Year | 09 | Month | 04 | 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
| 2022 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 04 | Day |
Last modified on
| 2024 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059460
| 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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